METABOLIC (GLYCEMIC, INSULINEMIC & SATIETY) CHARACTERISTICS OF A NOVEL COMMON BEAN (Phaseolus Vulgaris L.) PRODUCT
Conditions: Type 2 Diabetes
Sponsor: Jomo Kenyatta University of Agriculture and Technology

METABOLIC (GLYCEMIC, INSULINEMIC & SATIETY) CHARACTERISTICS OF A 
NOVEL COMMON BEAN (Phaseolus vulgaris L.)  PRODUCT 
Principal 
Investigator 
*KYALLO, 
Florence (Ph.D.) 
Jomo Kenyatta 
University of 
Agriculture and 
Technology, Kenya 
fkyallo@jkuat.ac.ke; 
kyallofm@gmail.com 
Mobile: +254 722693523 
P.O. BOX 62000-00200, Nairobi 
 
Co-Principal 
Investigator 
Prof. MATTHYS 
Christophe (Ph.D.) 
University of 
Leuven/University 
Hospital Leuven, 
Belgium 
christophe.matthys@uzleuven.be 
Tel: +32 16 34 26 55 
UZ Herestraat 49 - box 7003 44 
3000 Leuven 
Co-Investigator 
KIAGE, Beatrice 
N. (Ph.D.) 
 
Jomo Kenyatta 
University of 
Agriculture and 
Technology, Kenya 
Mobile: +254711641359 
P.O. BOX 62000-00200, Nairobi 
 
 
Co-Investigator 
Prof. Dr. VAN 
DER SCHUEREN, 
Bart 
University of 
Leuven/University 
Hospital Leuven, 
Belgium 
bart.vanderschueren@kuleuven.be 
Tel: +32 16 37 62 79 
UZ Herestraat 49 - box 7003 44 
3000 Leuven 
Co-Investigator 
(PhD Student) 
MUTWIRI Linet 
Nkirote 
Meru University of 
Science and 
Technology, Kenya 
nkirotte@gmail.com 
Mobile: +254 714 223507 
P.O. Box 595-60200, Meru. 
 
*Corresponding investigator 
 
October, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
List of acronyms and abbreviations............................................................................................... 5 
1. 
INTRODUCTION/BACKGROUND ..................................................................................... 6 
2. 
PROBLEM STATEMENT AND JUSTIFICATION ................................................................ 7 
Problem Statement ................................................................................................................. 7 
Problem justification............................................................................................................... 7 
3. 
REVIEW OF LITERATURE ............................................................................................... 8 
3.1 Double burden of malnutrition at the individual level.............................................................. 8 
3.2 Nutritional profile of common beans .................................................................................... 9 
3.3 Estimated Average Requirements (EARs) for Zinc, Iron and Copper......................................... 9 
3.4 Satiety and satiation..........................................................................................................10 
3.5 Insulin and glucose responses to food consumption ...............................................................10 
4. 
RESEARCH OBJECTIVES ................................................................................................11 
4.1 General objective .............................................................................................................11 
5. 
CONCEPTUAL FRAMEWORK AND OPERATIONALIZATION ..........................................11 
5.1 Conceptual framework ......................................................................................................11 
5.2 Operational definition of variables ......................................................................................12 
6. 
HYPOTHESES AND RESEARCH QUESTIONS ..................................................................13 
6.1 Hypotheses .....................................................................................................................13 
6.2 Research questions ...........................................................................................................13 
7. 
STUDY DESIGN AND SAMPLING STRATEGY.................................................................13 
7.1 Glycemic index (GI) and glycemic response study ................................................................13 
7.2 Food insulin index (FII) and insulin response .......................................................................15 
7.4 GI and FII study procedures...............................................................................................16 
7.5 Appetite scores using Visual Analog Scales (VAS) ...............................................................17 
8. 
DATA COLLECTION .......................................................................................................18 
8.1 Data collection processes...................................................................................................18 
8.2 Recruitment and Training of Research Assistants ..................................................................19 
8.3 Recruitment and Training of Phlebotomists ..........................................................................20 
8.4 Pre-testing of the tools ......................................................................................................20 
8.5 Reliability .......................................................................................................................20 
8.6 Ethical Considerations ......................................................................................................20 
8.7 Quality Control ................................................................................................................21 

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9. 
DATA PROCESSING AND ANALYSIS..............................................................................21 
9.1 Laboratory Analyses.........................................................................................................21 
9.2 Glycemic and insulinemic tests ..........................................................................................22 
9.3 Appetite scores ................................................................................................................23 
10. 
STUDY FINDINGS COMMUNICATION PLAN ...............................................................23 
11. 
STUDY LIMITATIONS AND RISKS ..............................................................................24 
12. 
MANAGEMENT AND ORGANIZATION OF THE STUDY...............................................24 
12.1 Team, members and roles ................................................................................................24 
12.2 Work plan .....................................................................................................................25 
12.3 Budget ..........................................................................................................................26 
13. 
REFERENCES AND APPENDICIES ...............................................................................28 
13.1 References ....................................................................................................................28 
13.2 Appendices....................................................................................................................31 
Appendix 1a: Information sheet and informed consent form for metabolic (glycemic, insulinemic 
and satiety) characteristics of a novel common bean product study ............................................31 
Appendix 1b: Information sheet and informed consent form for metabolic (glycemic, insulinemic 
and satiety) characteristics of a novel common bean product study ............................................33 
Appendix 1c: Research Assistant Confidentiality Agreement for metabolic (glycemic, insulinemic 
and satiety) characteristics of a novel common bean product study ............................................35 
Appendix 2: Questionnaire for glycemic and insulinemic response study. ...................................37 
Appendix 3: VAS in assessment of appetite sensations ............................................................39 
Appendix 4: CVs of Team Members .....................................................................................40 
CV of Dr. Florence Kyallo......................................................................................................40 
CV of Prof. dr. Christophe Matthys ..........................................................................................44 
CV of Dr. Beatrice N. Kiage ...................................................................................................47 
CV of Prof. Dr. Bart Van der Schueren .....................................................................................50 
CV of Linet N. Mutwiri..........................................................................................................52 
Appendix 6: Ethics Training Certificates ...............................................................................54 
Appendix 7: Adherence measures COVID 19 prevention and control regulations (adopted from 
Ministry of Health, Kenya)..................................................................................................59 
 
 
 

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List of Tables 
Table 1: Zinc, Iron and Copper EAR Summary, Ages 18 years and older ........................................... 9 
 
List of Figures 
Figure 1: Conceptual framework on how common beans can increase nutrient intake, and potentially 
improve metabolic responses in T2DM patients.............................................................................12 
Figure 2: Factors influencing consumer acceptance and preference ......... Error! Bookmark not defined. 
Figure 3: Factors influencing glycemic and insulinemic responses.......... Error! Bookmark not defined. 
Figure 4: Protocol for the assessment of postprandial glycemic, insulinemic and satiiety responses .......18 
 
 
 

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List of acronyms and abbreviations 
AMREF-ESRC  
African Medical Research Foundation-Ethics & Scientific Review 
 
 
 
 
Committee 
BIA 
 
 
Bioelectrical impedance analysis 
EAR 
 
 
Estimated average requirement 
EP 
FII 
 
 
Food insulin index 
GI 
 
 
Glycemic index 
GL 
 
 
Glycemic load 
iAUC 
 
 
Incremental area under the curve 
IUC 
 
 
Inter-university cooperation 
JKUAT  
 
Jomo Kenyatta University of Agriculture and Technology 
KEMRI  
 
Kenya Medical and Research Institute 
KU Leuven 
 
University of Leuven 
LCEFoNS 
 
Legumes Centre of Excellence for Food and Nutritional Security 
MoH 
 
 
Ministry of Health 
NACOSTI 
 
National Commission for Science, Technology and Innovation 
CoV 
 
 
Co-efficient of variance 
SEM 
 
 
Standard error of means 
SOP 
 
 
Standard operating procedure 
T2DM  
 
Type-2 diabetes mellitus 
VAS 
 
 
Visual analog sales 
VUB 
 
 
University of Brussels 
 

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1. INTRODUCTION/BACKGROUND 
Kenya is classified as having three main forms of malnutrition: overweight, anaemia and stunting 
[1], exhibiting a double burden of malnutrition nutritional landscape [2]. Indicators of overweight 
and obesity, and diabetes in both adult men and women either show no progress or are worsening 
when looking at trends from the 80’s to present [3]. Iron and zinc, whose deficiencies (acute or 
chronic) manifest as iron deficiency anaemia and stunting are micronutrients of public health 
concern in Kenya [4]. Type-2 diabetes is one of the priority non-communicable diseases (NCDs) 
[5] in Kenya with a prevalence of 5.8% and 6.2% in men and women [6].  
Type 2 diabetes (T2DM) is the most common form of diabetes. It is a chronic metabolic disease 
occurring when the pancreas is unable to produce sufficient amounts of insulin or when the body 
cannot effectively utilize produced insulin, or both. Insulin regulates the amount of glucose in 
blood and T2DM is characterized by hyperglycemia [7]. Diabetes due to its nature has an 
inflammatory disease character, with higher inflammatory processes as a result of diseases 
duration and glycemic control [8]. Iron homeostatsis is affected by hepcidin levels. Hepcidin levels 
are abnormally high during inflammation, resulting in a decrease in iron uptake in the gut [9]. 
Investigators have observed positive associations between serum ferritin and blood glucose levels, 
body mass index (BMI) and lipid profiles [11, 12]. This suggests that the incidence of anemia is 
likely to increase in poorly controlled diabetes. Therefore, reducing blood glucose levels could 
help reduce the risk of anemia in diabetic populations. Zinc is found in highest concentrations in 
the pancreatic β‐cell in the human body [12]. Dysregulation of zinc is known to occur in both type 
1 and type 2 diabetes. However there is no conclusive evidence as to whether zinc deficiency 
causes the diabetes or is merely a consequence of the disease [13]. Suggested potential beneficial 
mechanisms of action of zinc among diabetes patients are its antioxidant role. Studies have 
reported the association of high zinc levels with reduced oxidative stress (lowering lipid 
peroxidation [14], chronic hyperglycemia, insulin resistance  and β‐cell loss [15]). 
We conducted a baseline study during quarter 4, 2018 in Makueni County to study the double 
burden of malnutrition at the individual level in T2DM (N=168). Preliminary reports from the 
study show anaemia as present in 34.4% and 24.8% in men and women respectively. 142 
participants had a random blood sugar of >8.5mmol/L. 72.2% of the participants were also 

7 
 
hypertensive (reported current use of hypertension medication). Diets consumed were 
characterized by low sources of readily bioavailable iron and zinc. Diet quality is at the core of 
both diabetes management and the double burden of malnutrition. From the daily consumption 
data, we found the intake of both iron and zinc to be lower than their respective estimated average 
requirement (EAR). Further considering the characteristic low bioavailability diet, improvements 
in the quality of diets among this population is thus crucial. 
This study aims to study the associated glucose, insulin and appetite responses associated with the 
consumption of a novel common bean product. This product profiling is key to inform dietary 
management of T2DM patients using this specific product. 
2. PROBLEM STATEMENT AND JUSTIFICATION 
Problem Statement 
Though prevalence of T2DM in Makueni County is unknown, a high number of diabetes-related 
outpatient morbidity cases has been reported [16]. The double burden of malnutrition at the 
individual level has hardly been little studied and is less well understood than the prevalence of 
the double burden of malnutrition observed at country or household level.  
Zinc is found in very high concentrations in pancreatic beta-cells [17]. Low zinc levels have been 
reported elsewhere among diabetes patients as compared to non-diabetic patients [18]. 
Associations between dysregulation in zinc homeostasis and pancreatic beta-cell function has been 
suggested [19]. Evidence is however still inconclusive as to whether zinc deficiency causes the 
disease or is a consequence of the disease [15]. Studies suggest that inflammatory state associated 
with obesity lead to alterations in iron homeostasis. However, work on iron metabolism during 
inflammation has been focused on studies on obesity combined with anemia in women, or in 
persons undergoing bariatric surgery [20, 21]. The metabolic basis and complications associated 
with T2DM result in dysregulation in zinc, iron and copper homeostasis. Dietary management of 
T2DM has concentrated on macronutrient consumption[22, 23].  
Problem justification 
Micronutrients are cofactors in β-cell function, glucose metabolic pathways, and in insulin 
signaling. Baseline data shows us inadequate mean daily zinc and iron intakes in a characteristic 
low bioavailable diet. Additionally, presence of anaemia was >20% in T2DM patients in Makueni, 

8 
 
Kenya (N=168). The successes and challenges of diet and food-based approaches have been 
addressed before [24]. Despite the knowledge that several nutrients are implicated in glycaemic 
control: 1) limited studies and evidence on micronutrient status among T2DM patients in Kenya 
is available, and, 2)  limited evidence on targeted improved micronutrient consumption has been 
conducted in Kenya. To tackle both, micronutrient deficiency and metabolic health a new common 
bean product has been developed. We hypothesize that the newly developed product will have 
improved micronutrient bioaccessibility and that it will evoke desirable satiation and metabolic 
responses. Additionally, common beans contain soluble and insoluble fibre, phytonutrients and 
slowly digestible starch which are beneficial to glycaemic and lipaemic control. 
3. REVIEW OF LITERATURE 
3.1 Double burden of malnutrition at the individual level 
T2DM in Kenya is on a rise with about 458,900 people diagnosed in 2017 and a 2.5 fold projected 
increase [25]. It is one of the NCDs accounting a big proportion of NCD-related mortality[26]. 
Risk factors of T2DM in Kenya are: age, physical inactivity, adoption of unhealthy lifestyles [5, 
20].  Chronic hyperglycemia associated with T2DM results either in production of reactive oxygen 
radicals and/or compromises the antioxidant defense system activity [28]. In T2DM patients, zinc 
improves oxidative stress by a plethora of mechanisms: reducing chronic hyperglycemia, acting 
as a cofactor of the superoxide dismutase enzyme [29], regulating glutathione metabolism  and 
metallothionein expression [30], and promoting phosphorylation of insulin receptors[31]. Copper 
is a necessary pro-oxidant for the catalytic activity of superoxide dismutase [32]. Zinc and copper 
are important for balanced redox mechanisms. Imbalances in redox mechanisms may contribute 
to diabetic complications. The importance of antioxidant nutrients in the management of this 
disease should be further explored. 
Dysregulation of iron homeostasis is closely linked to the body’s inflammatory response and 
T2DM. As yet, the link between dietary iron and metabolic dysfunction is incompletely understood 
[25, 26]. Hepcidin controls dietary iron absorption and distribution in metabolic tissues. Hepcidin 
binds ferroportin in iron storage tissues inhibiting export of iron. Several studies have found high 
ferritin levels in T2DM patients. In enterocytes, inhibition of ferroportin reduces the absorption of 
dietary iron into the blood by trapping it within the enterocyte [35]. With both iron deficiency and 

9 
 
overload associated with metabolic disorder, it is important to maintain iron levels within a narrow 
physiological range. 
3.2 Nutritional profile of common beans 
Several studies report that common bean is a food with a high content of proteins, carbohydrates, 
diet fiber, minerals and vitamins [36]. Depending on the common bean variant, protein ranges 
between 14% and 33%. They contain amino acids such as lysine, phenylalanine and tyrosine. They 
lack in methionine and cysteine (sulphur amino acids). Beans contain slowly digestible 
carbohydrates and a high proportion of non-digestible carbohydrates. Fiber (soluble and non-
soluble) in beans would be beneficial to T2DM patients by reducing macronutrient absorption, 
satiety increase, increased sensibility to insulin, effects on inflammatory markers and on intestinal 
microbiota [37]. Common beans are important sources of iron and zinc. Moreover, they contain 
several bioactive compounds (anthocyanins, condensed tannins [38] and flavonoids [39]) 
possessing anti-inflammatory, antioxidant and other biological activity [40]. Due to their 
composition and effects, common beans have attractive properties for T2DM patients. 
3.3 Estimated Average Requirements (EARs) for Zinc, Iron and Copper 
The EARs for zinc, iron, and copper differ depend on age, body weight, sex, for pregnant and/or 
lactating women and on the bioavailability of the nutrient in a diet. Based on these factors 
approximate EAR values for adults’ ≥18 years and ≥70 years are shown in Table 1 below: 
Table 1: Zinc, Iron and Copper EAR Summary, Ages 18 years and older 
Micronutrient 
Male 
Female 
Zinc(mg/day) 
8.5 – 9.4 
6.8 – 7.3 
Iron (mg/day) 
6 – 7.7 
5 – 8.1 
Copper (μg/day) 
685 - 700 
685 - 700  
Source: adopted from Institute of Medicine (US) Panel on Micronutrients (2001) 
 It is important to remember that dietary reference intake values are set for healthy individuals, and 
nutrient requirements are likely to be differ in disease.  

10 
 
3.4 Satiety and satiation 
Satiety is defined as the extent to which feelings of hunger and desire to eating are reduced between 
meals (prompts termination of eating). Satiation refers to the amount of food consumed within a 
meal (fullness that persists after eating) [41]. Both are key factors in appetite control and energy 
intake. Satiety determines the length of time until next eating occasion and satiation the amount 
consumed at one sitting. Few studies have been conducted on satiety in the context of legumes and 
weight management. Studies suggest short  term improvements in satiety [37,38] and favorable 
influence on appetite sensations and energy intake in legume based meals when compared to 
animal based meals[44]. Satiety can be subjectively measured using visual analog scales (VAS) 
while satiation can be assessed by ad libitum consumption of test foods. 
3.5 Insulin and glucose responses to food consumption  
Following food consumption, absorbed carbohydrates give a rise in blood glucose concentrations. 
In response insulin is released causing blood glucose to fall. Different food components evoke 
different responses e.g. simple sugars give both rapid increases and falls. Glucose response refers 
to the degree of rise and fall in blood glucose levels and the time interval within which it occurs. 
Slowly digestible carbohydrates show a slower and more prolonged increase in blood glucose 
levels (with a lower peak) and vice versa. The glycemic index (GI) shows the average glucose 
concentration in the blood after consumption of a certain food (usually for 2 hours) relative to a 
standard food. The test foods usually contain 50 grams (or 25 grams if portion size is very large) 
of available carbohydrate and the reference food (anhydrous glucose powder, 50g or dextrose, 
55g) has a GI of 100 [45] . Available carbohydrate of a food is estimated by difference: 100 - water 
(g/100 g EP) - total fat (g/100g EP) - total protein (g/100 g EP) - total dietary fibre (g/100 g EP) 
- ash (g/100 g EP). The GI is obtained from the area under the 2hour curve (iAUC)1 [46] as: 
iAUC of the test food
individual subjects′average iAUC of the reference food* 100. Overall GI is calculated as mean (±SEM) GI 
value for ≥10 participants. From the GI, the glycaemic load (GL) can be derived. It is calculated 
                                                             
1 The incremental area under the curve has been calculated as the incremental area under the blood glucose 
response curve (iAUC), ignoring the area beneath the fasting concentration. This can be calculated geometrically by 
applying the trapezoid rule. When a blood glucose value falls below the baseline, only the area above the fasting 
level is included. 

11 
 
as: 
GI
Total available carbohydrate in the food portion /100. GL gives information on glycaemic quantity as 
a factor of food portion size, and may be used as an indicator of insulin demand.  
Insulin release can be triggered by other food components such as proteins and fats. The food 
insulin index (FII) allows for testing of foods with no or low carbohydrate content. It shows the 
observed (plasma) insulinemic response to consumption of a particular food compared to an iso-
caloric portion of the reference food over a 2 hour period. It is obtained as: 
iAUC for 1000kJ test food
iAUC for 1000kJ reference food * 100. FII has previously been reported to have potential of reducing 
postprandial hyperinsulinaemia in T2DM management [47]. 
4.  RESEARCH OBJECTIVES 
4.1 General objective 
1. To assess the appetite, insulin and blood glucose responses associated with consumption 
of  an acceptable novel common bean product 
 
5. CONCEPTUAL FRAMEWORK AND OPERATIONALIZATION 
5.1 Conceptual framework 
Common beans in type 2 diabetes patients could have many health benefits such as modulation of 
glucose metabolism, reduction of low density lipoproteins, and satiety [48,49] . The conceptual 
framework (Fig. 1) we have adopted proposes that short term metabolic responses are a factor of 
baseline characteristics of an individual, common bean product portion and feeding frequency 
[50].  

12 
 
 
 
 
 
 
 
= 
    X 
 X  
 
 
 
 
Figure 1: Conceptual framework on how common beans can increase nutrient intake, and 
potentially improve metabolic responses in T2DM patients 
For T2DM patients, portion control is one of the pillars in dietary management. Based on the main 
ingredient (common bean), form (solid), nutrient composition (available carbohydrate, fibre and 
protein) and oral processing needed (high sensory exposure/chewing time), we aim to develop a 
product that is highly satiating. The portion will also be influenced by the product packaging size 
of approximately 150-200 grams. 
The frequency and timing of the common bean product is also key. From the baseline study, 
majority of the T2DM were between 40-69 years. Age is associated with loss of appetite. In such 
a population group, small portions and frequent meals are recommended. We aim to provide a 
product that allows for optimization of the intake of vitamins and minerals in adults [48, 49].  
5.2 Operational definition of variables 
For the assessment of metabolic responses associated with consumption of the common bean 
product, Figure 2 below illustrates the relationship between the dependent (blood sugar, insulin) 
and independent variable (common bean product consumption): 
 
 
 
 
 
Appetite, 
insulin and 
blood glucose 
responses 
Baseline 
characteristics 
Feeding 
frequency 
Product portion 
Common bean 
product consumption 
Blood glucose 
Insulin 
C-reactive protein 
Lipid profile 
Adiposity measures 
Physical activity levels 
Dietary intake 
Diabetes management regimen 

13 
 
 
Figure 2: Factors influencing glycemic and insulinemic responses 
Recent evidence suggests that CRP levels are higher in people with diabetes compared with those 
without diabetes. However, less is known about whether CRP in people with diabetes is related to 
level of glycemic control. Poor glycemic control is significantly associated with the development 
of macrovascular complications of diabetes. We will be using the CRP data to evaluate association 
with glycemic control in this particular population. The lipid profile, dietary intake and bio-
electrical impedance data are some of the variables that will be used to explain observed blood 
glucose and insulin measurements. 
6. HYPOTHESES AND RESEARCH QUESTIONS 
6.1 Hypotheses 
H1: the new common bean product is not associated with desirable satiety, glycemic and 
insulinemic responses in the T2DM patients. 
 
6.2 Research questions 
1. What are the post prandial insulin, blood glucose and appetite responses associated with 
consumption of the common bean product in:  
a. healthy volunteers?  
b. T2DM patients? 
 
7. STUDY DESIGN AND SAMPLING STRATEGY  
7.1 Glycemic index (GI) and glycemic response study 
The GI evaluates the blood-raising ability of equi-carbohydrate portions of different single foods 
or mixed meals. To assess the GI of the common bean product in vivo, 10 healthy volunteers will 
be recruited. The selection of the number of participants, and the inclusion and exlusion criteria is 
based on the ISO_26642_2010 standard [53]. 
The 10 healthy volunteers will be recruited from Jomo Kenyatta University of Agriculture and 
Technology (JKUAT) and handled at the JKUAT University Hospital.  

14 
 
Inclusion criteria: 
 Male or female 18-69 years 
 No known food allergies or intolerances 
 No prescription medication2 (excluding oral contraceptives) known to affect glucose 
intolerance (e.g. steroids, protease inhibitors, antipsychotics e.t.c.)  
Exclusion criteria 
 Known history of diabetes mellitus or use of anti-hyperglycaemic medication or insulin 
 Alcohol or tobacco use in the evening preceding the test 
 Vigorous exercise on the morning of the test  
 Undergone major medical/surgical event needing hospitalization within the preceding 3 
months 
 Presence of disease or drug influencing digestion and absorption of medicine 
Glycemic response associated with consumption of the common bean product will be assessed in 
10 T2DM patients in Makueni County. The participants will be recruited from the Makueni Level-
5 and Mbooni sub-county hospitals which run a diabetes outpatient clinic.  
Inclusion criteria: 
 Male or female aged 18-69 years 
 Previously diagnosed with type 2 diabetes 
 Consenting to participate  
Exclusion criteria: 
 Use of prescription medication 
 History of eating disorders and irregular eating habits 
 Use of tobacco or alcohol 
 Females experiencing menstrual period or adverse premenstrual symptoms 
For the reference food, we will use either anhydrous glucose powder, 50g or dextrose (glucose 
monohydrate), 55g. The reference food will be dissolved in 250ml of water and refrigerated for 
use within 72 hours after preparation. Participants will be fed with an equi-carbohydrate portion 
of the common bean product to the reference food.  
                                                             
2 Stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to 
treat hypertension or osteoporosis are acceptable 

15 
 
 
The GI of the food will be measured over a 120 min period starting at the ingestion of the common 
bean product. The test food and reference food will be assessed in each subject on separate days 
with a 1 week period between each study day. 
 
The GI value of the common bean product will be calculated as follows: = [iAUC of the common 
bean product/individual subject’s average iAUC of reference food]*100. The overall GI will then 
be obtained as: The mean GI value for the 10 participants. 
The test conditions, sample size and methodology are as adopted from the international standard 
ISO 26642:20110(E)3 [53]. 
7.2 Food insulin index (FII) and insulin response 
To assess the FII of the common bean product in vivo, 10 healthy volunteers will be recruited from 
Jomo Kenyatta University of Agriculture and Technology. Insulin response associated with 
consumption of the common bean product will be assessed in 10 T2DM patients in Makueni 
County. Participants will be fed with iso-caloric (240 kilocalorie) portions of the test food and 
reference food. 
 
Inclusion and exclusion criteria for the FII and insulin response used will be as cited in GI study 
(see section 7.1). 
 
The FII of the food will be measured over a 120 min period starting at the ingestion of the common 
bean product. The test food and reference food will be assessed in each subject on separate days 
with a 1 week period between each study day.  
 
The FII value of the common bean product will be calculated as follows: = [iAUC of the common 
bean product/individual subject’s average iAUC of reference food]*100. The overall FII will then 
be obtained as: The mean FII value for the 10 participants. 
 
                                                             
3 The standard was issued under licence to Christophe Matthys (co-principal investigator) 

16 
 
Insulin response associated with consumption of the common bean product will be assessed in 10 
T2DM patients in Makueni County. 
 
7.4 GI and FII study procedures 
Researchers will obtain signed consent from the participants before testing. For the GI and FII 
study, the common bean product will be served with a standard 250 ml portion of water. 
Participants will first receive the reference food and then the test food on separate mornings after 
a 10-12h overnight fast. The conditions and testing times during the test days will be as similar as 
possible. Participants will be asked beforehand to maintain their usual diet; avoid alcohol; and not 
engage in unusual or excessive physical activity on the day preceding the test. For the night 
preceding the test day, participants will be asked to eat a standard evening meal that allows for the 
10h fasting period prior to the study and refrain from eating and/or drinking (except for water). 
 
On the test day, arrival time to the hospital will be 0700h. The researchers will assist participants 
in filling out a 24 hour dietary recall. Anthropometric measurements (weight, height, waist and hip 
circumferences); blood pressure; and body composition using bioelectrical impedance analysis 
(BIA) will be assessed. The subsequent tests will be conducted while the participants are in a rested 
position. A catheter will be introduced in the cubital vein to obtain venous blood by a phlebotomist. 
Two blood samples will be obtained within a five minutes interval in the fasting state, and their 
average taken as the baseline blood glucose concentration (time -5 and time 0). Participants will 
then be given the test food and 250ml water all presented in standard bowls and/or glasses. 
Participants will be asked to eat the whole portion in 12 to 15 minutes, at an even pace. Time taken 
to eat the entire portion will then be recorded. Participants will remain seated and will be allowed 
to read or use their phones. They will however not be allowed to sleep or eat or drink until the end 
of the 2h of study period. 
 
Postprandial blood samples will be collected after the feeding at six time-points, 15, 30, 45, 60, 90 
and 120 min. For each time point, ~2 ml of blood will be obtained. Whole-blood samples will be 
labelled using codes allocated to each participant for proper identification. Blood glucose content 
will be measured in either whole blood or plasma samples. Centrifugation will be done within 30 
minutes of blood collection using portable centrifuges carried to the field. Blood plasma or serum 

17 
 
will then be pipetted into aliquots in cryovials, labelled, wrapped with aluminium foil and stored 
in liquid nitrogen awaiting transportation to LANCET laboratories for analysis. The blood samples 
will be analysed for blood glucose, insulin, lipid profile and C-reactive protein.  
 
7.5 Appetite scores using Visual Analog Scales (VAS) 
Appetite scores will be used to assess the satiety power of the test (common bean) product among 
T2DM participants. The appetite score will be taken on one study day, that is, after consumption 
of the bean product. Subjective measures of appetite will be taken prior to, and at predetermined 
time intervals after consumption of the test meal. Appetite score refers to the average between 
hunger, desire to eat, prospective consumption and a 100-fullness score. The appetite score will be 
assessed at before and after consumption of test product at time points 0, 15, 30, 45, 60, 90 and 
120 minutes. Participants will be given a short questionnaire to assess satiety. 
  
A single vertical mark best expressing the participants’ response will be made on an anchored 100 
mm VAS scale. The anchor on the left and right will express the most positive and the most 
negative rating respectively (see Appendix 7). The response will be quantified by measuring the 
distance between the left anchor and the marking made. The questionnaires will be made as a small 
brochure booklet showing one question at a time [54][55]. Participants will be asked to remain 
silent while filling out their VAS. Between evaluations, they will be allowed to read or use their 
phones. The participants will not be allowed to discuss with each other or refer to previous ratings 
when filling out the VAS. 
 
240 kcal/ (50g or 25g 
available 
carbohydrate; 
250 ml H20 
 
 
 
 
 
 
 
0800h 
0815h 
0830h 
0845h 
0900h 
0930h 
 
1000h 
 
 
 
 
 
 
 
 
 
 
 
Fasting 
T=-5 min 
and 0min 
 
 
T=15 
min 
 
 
T=30min 
 
 
T=45min 
 
 
T=60min 
 
 
T=90min 
 
 
 
T=120min 
 

18 
 
 
 
 
 
 
 
Blood draw + Appetite scores 
 
Figure 3: Summary of protocol for the assessment of postprandial glycemic, insulinemic and 
satiety responses 
8. DATA COLLECTION 
8.1 Data collection processes  
Glycemic index and glycemic response (Appendix 2) 
a. Equi-carbohydrate (50g or 25g) portions of the common bean product 
b. 24-hour of dietary recall  
c. Anthropometry: weight, height, waist & hip circumference 
d. Body composition: BIA 
e. Biochemical samples: Blood  
Food insulin index (FII) and insulin response (Appendix 2) 
a. Iso-caloric (240kJ) portions of the common bean product 
b. 24-hour of dietary recall  
c. Anthropometry: weight, height, waist & hip circumference 
d. Body composition: BIA 
e. Biochemical samples: Blood  
Appetite scores (Appendix 3) 
a. Visual analog scales 
b. Timers 
 
BIA will be assessed with the Bodystat 500 (Bodystat, UK). Raw data on impedance, resistance, 
reactance and phase angle will be added to already validated equations to calculate fat free mass, 
body fat and hydration [56]. 
For blood draw, handling and processing; phlebotomists from the Kenya Medical and Research 
Institute (KEMRI) will be engaged. A catheter will be place in the cubital vein. Blood samples 
will be collected at seven time-points; 0, 15, 30, 45, 60, 90 and 120 minutes. For each bleeding 
moment ~2 ml of blood will be drawn from the participant. Plain tubes will be used for blood 
collection. After collection, whole-blood samples will be labelled with codes with participant 

19 
 
codes and separated based on time-collection point. A drop of blood will then be obtained for 
determination of haemoglobin concentration using the Hemocue 301 portable device. The tubes 
will then be placed immediately into insulated coolers containing ice/cold packs at around 4oC 
awaiting centrifuging. Centrifuging will be within 30 minutes of sample collection. After 
centrifuging, serum will be separated and divided in aliquots. Cryovials containing the aliquots 
will be labelled (with participant code and test to be run), wrapped with aluminum foil (to reduce 
chances of light degradation) and secured together with rubber bands. They will then be put in a 
portable freezer. At the end of sample collection and separation, the aliquots will be dropped into 
a liquid nitrogen tank awaiting transportation to analytical laboratories (LANCET), for further 
analysis. Necessary precautions will be taken to ensure a dust and light free environment during 
the blood sample collection and handling.  
Single use for alcohol swabs, clean disposable latex-free gloves, disposable needles, catheters and 
plain tubes will be observed. Biological waste and sharps will be disposed appropriately in 
biological hazard bags and biohazard box respectively and later on disposed of together with the 
hospital waste at the participating hospital facilities in Makueni County and JKUAT hospitals. 
 
8.2 Recruitment and Training of Research Assistants  
Enumerators will be recruited to assist in screening, recruitment and data collection. The research 
team will engage persons with previous field study experience and knowledge of the local 
language. The nurse/nutrition officer in charge of nutrition support in the clinic will be requested 
to assist the researchers in recording blood glucose levels of the T2DM patients. A two day training 
will be designed by the research team to introduce the study, study objectives and applicable 
methods to the enumerators. The training will encompass taking of anthropometric measurements, 
interviewing techniques and data collection procedures, code of ethics, data management and 
proper interpretation of questions to avoid the error of individual subjectivity during the interview.  
Practical demonstrations, discussions and role play will be used to ensure standardization of 
interviewing skills, taking of body measurements, and will also help in familiarization with the 
research questions. The enumerators’ competence will be assessed by the research team a day after 
completion of the training session.  

20 
 
8.3 Recruitment and Training of Phlebotomists 
Phlebotomists from KEMRI will be engaged. Through a meeting with the research team, the study, 
study objectives, blood collection procedures, biomarkers for analysis, standard operating 
procedures (SOPs), biomarker quantification methods, equipment needs and any other 
practicalities will be reviewed. This will amount to the development of a laboratory analytical plan 
for this study.  
8.4 Pre-testing of the tools 
Questionnaires to be used for the studies will be pre-tested before the commencement of the 
studies. Participant with similar characteristics will be used for the pre-testing. 
8.5 Reliability  
Other than pre-testing of the questionnaires, training of research assistants on the questionnaire 
administration and anthropometric measurements will be done. Calibration of anthropometric 
equipment will be done routinely to enhance reliability. An average of two readings will be used 
to record anthropometric measurements. Appetite scores will be assessed using Cronbach’s alpha. 
Approved and standardized SOPs will be followed for different procedures in the different studies. 
8.6 Ethical Considerations 
Ethical clearance will be sought from the African Medical Research Foundation-Ethics & 
Scientific Review Committee (AMREF-ESRC). A Research permit will be obtained from National 
Council for Science, Technology and Innovation. Local authority/opinion leaders and Ministry of 
Health & hospital management will be briefed by the researcher on the intended activities prior to 
the start of the study. Approval for all data collection procedures and tools will be sought from the 
aforementioned committee.  
Information on the study will be explained to the local administration, hospital administration and 
study participants in open sessions during outpatient clinic days. The study will be introduced to 
the hospital management with an introductory letter and approvals obtained. A pre-visit will be 
made to the hospitals. The T2DM patients will be issued information sheets containing all 
information pertaining to the study. Consenting individuals will be recruited only after signing of 
the informed consent. 

21 
 
During recruitment, unique codes will be used for identification and all data obtained from study 
subjects will be handled with utmost confidentiality. Study documents containing personal 
information will be stored in a separate repository. In this case, this information will be removed 
from study documents where possible. Data collected will strictly be used for study purposes only. 
The process will consider interests of the study participants and will aim to protect their privacy, 
dignity and integrity. Access to files will be limited to the investigators. 
The data collection procedures will have no serious risks to participants. Placement of the catheter 
will cause only a little discomfort at the site of the needle prick. Necessary care will be taken to 
stop the discomfort in a short while within the same day. Their participation in this study will 
enable us assess responses to the new product from the intended (real) or potential consumers. 
This will be vital to enable product optimization if need be, and in deciding on the use of this 
product for a food intervention.  
For any unforeseen events due to participation in the study, T2DM participants will be immediately 
referred from the diabetes outpatient clinic to the casualty department of the same health facility 
for further examinations, treatment and follow up. The participants from JKUAT will be referred 
to the University hospital. 
A lunch meal will be provided to the study participants after the end of the activity. This is 
considering the participants come for the research early in the morning in a fasted state. 
8.7 Quality Control 
The research team will be trained and assessed based on standardized methods and tools as in this 
protocol. Biochemical analysis will be done at the KEMRI laboratories which participate in a series 
of inter-laboratory calibration exercises to validate analytical results. All equipment will be well 
maintained and internally calibrated during the entire study period.  
9. DATA PROCESSING AND ANALYSIS 
9.1 Laboratory Analyses  
Biochemical samples will be assessed for blood glucose, lipid profiles, insulin and C-peptide in 
serum, all in the fasted state. 

22 
 
9.2 Glycemic and insulinemic tests 
Allowable mean within-subject co-efficient of variance (CV) for the reference food is ≤30%. The 
laboratory's inter-assay analytical variation on standard solutions should be <3.6%. The 
laboratory's minute-to-minute analytical variation in human subjects for 20 or more duplicate 
measurements of fasting glucose should generally be <5 %. Glycemic and insulinemic responses 
will be obtained from the iAUC (incremental area under the curve). iAUC is calculated by applying 
the trapezoid rule (sums of the areas of the triangles and trapezoids) [53]. iAUC is reported in 
millimole minutes per litre. Below is an example to how the iAUC and GI will be arrived at: 
Table 2: Sample blood glucose responses to the ingestion of a 50g carbohydrate portion 
Food sample 
Time of sampling, min 
iAUC 
0 
15 
40 
45 
60 
90 
120 
Reference food replicate 1 
4.3 
6.3 
7.9 
5.3 
4.1 
4.6 
4.9 
114 
Reference food replicate 2 
4.0 
6.0 
6.7 
5.5 
5.3 
5.0 
4.2 
155 
Test food 
4.0 
5.0 
5.8 
5.4 
4.8 
4.2 
4.4 
93 
 The iAUC for the Reference food replicate 1 = sums of the areas of the triangles and trapezoids 
A to F obtained after plotting the blood glucose responses at the different time intervals on a graph 
(Fig. 4). 
 
Figure 4: Graph of blood glucose responses to the ingestion of a 50g carbohydrate portion over a 
2h period 

23 
 
Calculation for GI 
 Mean iAUC for the reference food= (iAUC reference food replicate 1+ iAUC reference 
food replicate 2)/ 2= 135±29 mmol min/l 
 The CoV is thus 29/135*100 = 22% (Test condition: CV for the reference food for the 
group should be ≤30%). 
 iAUC for test food is 93 mmol min/l. For this subject, GI of the test food is thus 
93/135*100 = 69%. 
 
9.3 Appetite scores 
Averages of markings on the VAS for all the participants will be calculated. Descriptive data will 
be expressed as means and/or standard errors or deviations. Cronbach’s alpha will be used to assess 
validity of the appetite scores. ANOVA, Tukey’s significant difference test and Pearsons 
correlation will be used to analyze the effects of product consumption and composition on appetite 
scores and to assess the repeatability. 
Data will be coded, entered and analysed using either/or SPSS, R, Excel or STATA software. 
10.  STUDY FINDINGS COMMUNICATION PLAN 
Varied approaches (based on intended audience) will be used to disseminate salient study findings. 
Findings will be published in peer-reviewed journals and also presented in conferences, research 
seminars and workshops through oral or poster presentations.  Reports will also be shared with 
Ministries of Health, participating hospitals, LCEFoNS programme platform (hosted by JKUAT 
website). Letters of thanks to participating hospitals with study updates will be done upon 
completion of data analysis [57].  
Key stakeholders to be included in dissemination of the study include Ministry of Health (MOH), 
Kenya; Kenya Medical Research Institute (KEMRI) and relevant Non-Governmental 
Organisations, (participating) T2DM patients, T2DM patient support groups where they exist (at 
community level this are psychosocial support groups to raise the level of self-care and adherence 
to treatment), nutritionists/personnel in charge clinics where participants will be recruited from 
and community leaders. 

24 
 
11. STUDY LIMITATIONS AND RISKS 
Limitations include assessment of one test product. Additionally, when determining the GI and 
FII, a limitation is in the inter-individual, day-to-day, and even within-day variance in glycemic 
and insulinemic response to a particular food. For this, we will adhere to recommendations from 
the ISO 26642:2010 (e.g. testing the reference food twice to reduce day-to-day variability within 
individuals, follow recommendations as in protocol section 9.2 among other guidelines).  
12. MANAGEMENT AND ORGANIZATION OF THE STUDY 
12.1 Team, members and roles 
This study is being implemented through The Legumes in Human Nutrition and Health Project, 
which is one of the four projects of the Legumes Centre of Excellence for Food and Nutritional 
Security (LCEFoNS). LCEFoNS is an Inter-University Cooperation (IUC) programme between 
Jomo Kenyatta University of Agriculture and Technology (JKUAT), Kenya; University of Leuven 
(KU Leuven), Belgium and University of Brussels (VUB), Belgium. The IUC is funded by VLIR-
UOS, Belgium. Dr. Florence Kyallo is the project leader in Kenya (South) while Prof. Christophe 
Matthys is the project leader in Belgium (North). Prof. Tara Grauwet, Dr. Beatrice Kiage and Prof. 
Bart Van der Schueren are co-investigators in the study. Implementation of the study will be 
managed by Dr. Florence Kyallo, while Prof. Christophe Matthys will oversee the technical 
aspects of the study. All investigators are involved in the design and development, and 
implementation of study protocols. Ms.Linet Mutwiri, the PhD student in the study, will be 
responsible for data collection, analysis and reporting under guidance of the other 5 investigators. 

12.2 Work plan 
 
 
 
 
 
Year 2020 - 2021 
July-Sept 20 Oct-Nov 20 
Dec 20-Jan 21 
Feb-Mar 21 
Apr-July 21 
Work Package 1: Protocol preparation 
Proposal writing 
 
 
 
 
 
Submission of proposal for ethical clearance  
 
 
 
 
 
Expected response from ethical body 
 
 
 
 
 
Submission to NACOSTI and expected response 
 
 
 
 
 
Work Package 2: Metabolic studies 
Review of data collection tools 
 
 
 
 
 
Introductory visit to community/local (opinion) leaders/MoH 
Makueni/JKUAT/JKUAT hospital  to inform on research intent 
 
 
 
 
 
Recruitment and training of research assistants  
 
 
 
 
 
Gathering all data collecting tools 
 
 
 
 
 
Pre-test, review of data collection tools, and pre-test report 
 
 
 
 
 
Issuance of consent forms and data collection in the various study sites  
 
 
 
 
 
Data collection 
 
 
 
 
 
Analysis at LANCET and receipt of results 
 
 
 
 
 
Work Package 3: Data analysis 
Data compilation and analysis 
 
 
 
 
 
Report submission and dissemination (stakeholders) 
 
 
 
 
 

12.3 Budget 
Item 
Unit(s) required 
Unit Price(KSh) 
Amount (KSh) 
Ethics and Scientific Review 
Ethical clearance fee (AMREF) 
- 
- 
5,000 
Research approval by NACOSTI 
- 
- 
2,000 
Sub-total 
- 
- 
7,000 
Protocol costs 
ISO 26642 standard 
1 
9,000 
9,000 
Sub-total 
- 
- 
9,000 
Training Costs 
Training of 2 enumerators (2 days) 
2 
2,200 
4,400 
Meeting with phlebotomy team 
2 
6,300 
12,600 
Transport 
6 
600 
3,600 
Sub-total 
- 
- 
20,600 
Data collection costs 
Phlebotomy (4 days & 2 
phleobotomists) 
8 
7,640 
61,120 
Team leader (4 days) 
2 
7,640 
15,280 
PhD student (4 days) 
4 
7,640 
30,560 
Enumerators (4 days) 
8 
2,540 
20,320 
Driver (4 days) 
4 
5,135 
20,540 
Fuel 
 
20,000 
20,000 
Participant lunch (3 days) 
30 
500 
15,000 
Community mobiliser (4 days) 
4 
2,240 
8,960 
Stationery (paper for VAS scores) 
1 
500 
500 
2 dozen pens 
2 
300 
600 
Water (crates) 
4 
800 
3,200 
Airtime (4 study days) 
4 
500 
2,000 
Subtotal 
 
 
198,080 
Equipment and Consumables Costs 
Blood pressure measurement 
OMRON blood pressure monitor 
(digital, M2) 
1 
8,500 
8,500 
Subtotal 
 
 
8,500 
Collection, handling, storage and transfer of blood samples 
Butterfly needles (preferably size 
21G;22G;23G)  
80 
1500/100pc pkt 
1,500 
Flexible IV tube 
80 
200 
16,000 
Vacutainer tubes 
2 
1,200/100pcs 
2,400 
Vacutainer holder 
10 
250 
2,500 
Alcohol swabs 
80 
180/100 pieces 
180 
Disposable rubber gloves 
1 
250/100 pieces 
250 

27 
 
Bio-hazard box 
2 
50/pc 
100 
Biological waste disposal bag (20l) 
3 
15 
45 
Hand sanitizer 
1 
500 
500 
Cryogenic vials (freezable) 
2 
1,200/100pcs 
2,400 
Disposable pipettes or pipettes with 
changeable apex 
2 
4,500 
9,000 
Blue tips 
1 
1,200/1000pcs 
1,200 
Centrifuge, 12 tubes with timer  
1 
20,000 
20,000 
Permanent marker pens 
4 
250 
1,000 
Cool boxes (Thermos, 28lit) 
2 
3,000 
6,000 
Ice packs 
10 
400/pc 
4,000 
Liquid nitrogen 
50 
480/kg 
24,000 
Subtotal 
 
 
91,075 
Anthropometric and body composition measurements 
Tefal Weight scale 
4 
4,000/pc 
16,000 
Seca portable/wall mounted 
stadiometer with movable head piece, 
or measuring rod 
4 
7,000/pc 
28,000 
Waist circumference tape 
10 
1000/pc 
10,000 
Bodystat 500 
1 
80,00032 
80,000 
Subtotal 
 
 
134,000 
Laboratory Blood Specimen Analysis Costs 
Blood glucose (30 fasting, 180 random) 
210 
649 
136,290 
Plasma insulin (fasting) 
30 
3,849 
115,470 
Plasma insulin (non-fasting) 
180 
4,149 
746,820 
C-peptide (fasting/non-fasting) 
20 
2,949 
58,980 
HbA1C 
20 
2,949 
58,980 
Lipid profile (Cholestrol, 
HDL,LDL,Trig+Ratio calculations) 
20 
2,949 
58,980 
Subtotal 
 
 
1,175,520 
TOTAL 
 
 
1,643,775 
Miscellaneous (flat rate) 
 
 
10,000 
GRAND TOTAL 
 
 
1,653,775 
Funding: VLIR-UoS 

28 
 
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and Diversity to Address Multiple Micronutrient Deficiency.,” Front. public Heal., vol. 3, p. 277, 
2015. 
[53] 
ISO, “ISO 26642:2010(en), Food products — Determination of the glycaemic index (GI) and 
recommendation for food classification,” 2010. [Online]. Available: 
https://www.iso.org/obp/ui/#iso:std:iso:26642:ed-1:v1:en. [Accessed: 04-Jul-2019]. 
[54] 
A. Flint, A. Raben, J. E. Blundell, and A. Astrup, “Reproducibility, power and validity of visual 
analogue scales in assessment of appetite sensations in single test meal studies,” Int. J. Obes., vol. 
24, no. 1, pp. 38–48, 2000. 
[55] 
A. Lesdéma et al., “When satiety evaluation is inspired by sensory analysis: A new approach,” 
Food Qual. Prefer., vol. 49, pp. 106–118, 2016. 
[56] 
Bodystat, “Body Fat Analysers and Hydration Monitors | Bodystat,” 2018. [Online]. Available: 
https://www.bodystat.com/. [Accessed: 09-Jul-2019]. 
[57] 
Community Alliance for Research and Engagement, “Beyond Scientific Publication: Strategies for 
Disseminating Research Findings.” 
 
 

31 
 
13.2 Appendices 
Appendix 1a: Information sheet and informed consent form for metabolic (glycemic, 
insulinemic and satiety) characteristics of a novel common bean product study 
Study No.: 
Study title: Metabolic characteristics of a novel common bean product (shortened version) 
Information sheet 
Introduction: 
 
We are researchers under the Legume Centre of Excellence for Food and Nutrition Security (LCEFoNS), a 
programme by Jomo Kenyatta University of Agriculture and Technology (JKUAT), University of Leuven 
(KU LEUVEN), and, University of Brussels (VUB).You are being invited to take part in a study 
investigating the glycemic and food insulin indices, and metabolic responses of a novel common bean 
product at Jomo Kenyatta University of Agriculture and Technology University Hospital.  
Your participation is voluntary. You have the right to refuse to participate in this study. Before you decide 
whether to participate in the trial, you need to fully understand what the study is about and why we conduct 
the trial. This consent form explain why the research is being done, what we will ask you to do during the 
study, the possible risks and benefits of participating, and the amount of time the study will require. Please 
take time to understand the following information carefully before you decide.  Once you understand the 
study, you will be asked to sign this form if you wish to participate. If you decide to participate, you may 
still choose to withdraw from the study at any time without giving any reason. Withdrawal from the study 
will not result in any negative consequences to the services to which you are entitled or are presently 
receiving. 
Purpose of the study: This study aims to study the associated glucose, insulin and appetite responses 
associated with the consumption of a novel common bean product.  
Procedure: If you agree to take part in this study, you are expected to attend all the 3 study visits, each 
lasting approximately 140 minutes. The reference food will be tested two (2) times and the test food (1) 
time in each participant on separate days within a 3 month period. During some of the study visits you will 
be asked to consume a reference food, which will be either a anhydrous glucose powder or dextrose (glucose 
monohydrate) beverage. On other study visits you will be asked to consume the test food, a food grade 
novel common bean product(s) from food grade ingredients though the application of conventional food 
processing technologies.  
Each study visit will include the following procedures: • Avoid all food and beverages including alcohol at 
least 10 hours before the study visit, and avoid vigorous exercise on the morning of the visit • Provide two 
fasting blood samples • Consume a specified portion of the reference or test food during various timepoints 
of the study (water will also be available) • Provide a blood sample at 15, 30, 45, 60, 90, and 120 minutes 
after beginning to eat the food 
Possible harms and discomforts: The blood collection procedure may cause some discomfort and slight 
bruising at the site of the lancet poke. After the blood draw you will immediately be given a ball of cotton 
dipped in surgical spirit to cover the spot where the blood was taken. There are no other known risks 
involved with participating in this research. 

32 
 
Potential benefits of participating: There are no direct benefits to participating in this study. We hope that 
the information on the common bean product will be used in the future to help consumers make informed 
food choices.  
Withdrawal to participate: You can withdraw participation at any time without giving reasons. If you 
consent to participate but decide to withdraw at a later moment, you can request the withdrawal of your 
information collected during the study. However, in cases where the data and/or samples are no longer 
identifiable/ cannot be linked back to your identity/data has been merged the request to withdraw data 
and/or samples may not be possible.  
Confidentiality: Your confidentiality will be highly respected. As a study participant, you will be issued a 
unique study code. Only this code will be used on any research related information collected about you. 
Information on your identity will remain only with the Principal Investigator and/or designate. The list that 
matches your name to the unique study number that is used on your research-related information will not 
be removed or released without your consent unless required by law.  
Who to Contact: If you have any questions, you can ask them now or later. If you wish to ask questions 
later, you may contact Linet Mutwiri, Mobile: +254714223507. 
Participant consent 
By signing this form: 
 
I have read and understood the information in this information and consent form. 
 
I have had enough time to think about the information provided. 
 
I have been able to ask questions and have had satisfactory responses to my questions. 
 
I understand that the purpose of this study is to assess the associated glucose, insulin and appetite 
responses associated with the consumption of a novel common bean product 
 
I understand that all of the information collected will be kept confidential and that the results will 
only be used for scientific purposes. 
 
I understand that my participation in this study is voluntary. I understand that I am completely free 
at any time to refuse to participate or to withdraw from this study at any time, and that this will not 
change the quality of care that I receive. 
 
I will receive a signed copy of this consent form for my own records. 
 
I consent to participate in this study. 
 
Participant signature 
 
 
Participant name 
 
 
Date 
_________________ 
 
 
_______________________________ ______________ 
Signature of person obtaining consent Name and role in study  
 
Date 
_________________ 
 
 
_______________________________ ______________ 
 
 

33 
 
Appendix 1b: Information sheet and informed consent form for metabolic (glycemic, 
insulinemic and satiety) characteristics of a novel common bean product study 
Study No.: 
Study title: Metabolic characteristics of a novel common bean product (shortened version) 
Information sheet 
Introduction: 
 
We are researchers under the Legume Centre of Excellence for Food and Nutrition Security (LCEFoNS), a 
programme by Jomo Kenyatta University of Agriculture and Technology (JKUAT), University of Leuven 
(KU LEUVEN), and, University of Brussels (VUB).You are being invited to take part in a study 
investigating the glycemic and food insulin indices, and metabolic responses of a novel common bean 
product at _______________ Hospital.  
Your participation is voluntary. You have the right to refuse to participate in this study. Before you decide 
whether to participate in the trial, you need to fully understand what the study is about and why we conduct 
the trial. This consent form explain why the research is being done, what we will ask you to do during the 
study, the possible risks and benefits of participating, and the amount of time the study will require. Please 
take time to understand the following information carefully before you decide.  Once you understand the 
study, you will be asked to sign this form if you wish to participate. If you decide to participate, you may 
still choose to withdraw from the study at any time without giving any reason. Withdrawal from the study 
will not result in any negative consequences to the services to which you are entitled or are presently 
receiving. 
Purpose of the study: This study aims to study the associated glucose, insulin and appetite responses 
associated with the consumption of a novel common bean product.  
Procedure: If you agree to take part in this study, you are expected to attend 1 study visit, lasting 
approximately 140 minutes. During study visit you will be asked to consume a test food, a food grade novel 
common bean product(s) from food grade ingredients though the application of conventional food 
processing technologies.  
Each study visit will include the following procedures: • Avoid all food and beverages including alcohol at 
least 10 hours before the study visit, and avoid vigorous exercise on the morning of the visit • Provide two 
fasting blood samples • Consume a specified portion of the reference or test food during various time points 
of the study (water will also be available) • Provide a blood sample and give an appetitie score for the 
product at 15, 30, 45, 60, 90, and 120 minutes after beginning to eat the food 
Possible harms and discomforts: The blood collection procedure may cause some discomfort and slight 
bruising at the site of the lancet poke. After the blood draw you will immediately be given a ball of cotton 
dipped in surgical spirit to cover the spot where the blood was taken. There are no other known risks 
involved with participating in this research. 
Potential benefits of participating: There are no direct benefits to participating in this study. We hope that 
the information on the common bean product will be used in the future to help consumers make informed 
food choices.  
Withdrawal to participate: You can withdraw participation at any time without giving reasons. If you 
consent to participate but decide to withdraw at a later moment, you can request the withdrawal of your 

34 
 
information collected during the study. However, in cases where the data and/or samples are no longer 
identifiable/ cannot be linked back to your identity/data has been merged the request to withdraw data 
and/or samples may not be possible.  
 
Confidentiality: Your confidentiality will be highly respected. As a study participant, you will be issued a 
unique study code. Only this code will be used on any research related information collected about you. 
Information on your identity will remain only with the Principal Investigator and/or designate. The list that 
matches your name to the unique study number that is used on your research-related information will not 
be removed or released without your consent unless required by law.  
Who to Contact: If you have any questions, you can ask them now or later. If you wish to ask questions 
later, you may contact Linet Mutwiri, Mobile: +254714223507. 
Participant consent 
By signing this form: 
 
I have read and understood the information in this information and consent form. 
 
I have had enough time to think about the information provided. 
 
I have been able to ask questions and have had satisfactory responses to my questions. 
 
I understand that the purpose of this study is to assess the associated glucose, insulin and appetite 
responses associated with the consumption of a novel common bean product 
 
I understand that all of the information collected will be kept confidential and that the results will 
only be used for scientific purposes. 
 
I understand that my participation in this study is voluntary. I understand that I am completely free 
at any time to refuse to participate or to withdraw from this study at any time, and that this will not 
change the quality of care that I receive. 
 
I will receive a signed copy of this consent form for my own records. 
 
I consent to participate in this study. 
 
Participant signature 
 
 
Participant name 
 
 
Date 
_________________ 
 
 
_______________________________ ______________ 
Signature of person obtaining consent Name and role in study  
 
Date 
_________________ 
 
 
_______________________________ ______________ 
 
 
 
 

35 
 
Appendix 1c: Research Assistant Confidentiality Agreement for metabolic (glycemic, 
insulinemic and satiety) characteristics of a novel common bean product study 
 
A.  
CONFIDENTIALITY OF A RESEARCH STUDY: 
 
Confidentiality is the treatment and maintenance of information that an individual has 
disclosed in a relationship of trust and with the expectation that it will not be divulged to 
others in ways that are inconsistent with the understanding of the original disclosure (the 
consent form) without permission. Confidential information relating to human subjects in 
a research study may include, but is not limited to: 
 
 Name, date of birth, age, sex, address, and contact information; 
 Current contact details of family, guardian etc.; 
 Medical or educational history and/or records; 
 Sexual lifestyle; 
 Personal care issues; 
 Service records and progress notes; 
 Assessments or reports; 
 Ethnic or racial origin; 
 Political opinions, religious or philosophical beliefs. 
 
As a research assistant you will have access to confidential information pertaining to the 
research study. Many participants have only revealed information to investigators because 
principal investigators have assured participants that every effort will be made to maintain 
confidentiality. That is why it is of the upmost importance to maintain full confidentiality 
when conducting a research study. Below is a list of expectations you will be required to 
adhere to as a research assistant. Please carefully review these expectations before signing 
this form.   
 
B.  
EXPECTATIONS FOR A RESEARCH ASSISTANT 
  
In order to maintain confidentiality, I agree to: 
 
1. Keep all research information that is shared with me (e.g. flash drives, notes, transcripts, 
data, etc.) confidential by not discussing or sharing this information verbally or in any 
format with anyone other than the principal investigator of this study;  
 
2. Ensure the security of research information while it is in my possession. This may 
include: 
 Keeping all documents and/or data related to the research study on a 
password protected computer with password protected files; 

36 
 
 Closing any programs, documents, or data files related to the research study 
when away from the computer; 
 Keeping any printed documents and/or data related to the research study in 
a secure location such as a locked filing cabinet; 
 Permanently deleting any digital communication containing documents 
and/or data related to the research study. 
 
3.  Not make copies of documents and/or data related to the research study unless 
specifically instructed to do so by the principal investigator; 
 
4. Give all research information/data and research participant information/data back to the 
principal investigator upon completion of my duties as a research assistant; 
 
5. After discussing it with the principal investigator, erase or destroy all research 
information that cannot be returned to the principal investigator upon completion of my 
duties as a research assistant.  
 
By signing this form I acknowledge that I have reviewed, understand, and agree to adhere 
to the expectations for a research assistant described above. I agree to maintain 
confidentiality while performing my duties as a research assistant and recognize that failure 
to comply with these expectations may result in disciplinary action.   
 
 
 
Name of Research Assistant:   
 
 
 
Signature: 
 
Mobile number: 
 
Name of Principal Investigator:  
 
 
 
Signature: 
 
 

37 
 
Appendix 2: Questionnaire for glycemic and insulinemic response study. 
Study No.: 
 
Participant code #: 
 
 
 
 
 
 
 
 
Date: 
 
Answer the following questions. Please tick [√] one 
1. Do you have a history of eating disorders and/or irregular eating habits? 
 
Yes [  ] 
No [  ] 
 
2. Do you currently use tobacco or alcohol? 
 
 
 
 
Yes [  ] No [  ] 
 
3. Are you on your menstrual period or having adverse premenstrual symptoms? 
Yes [  ] 
No [  ] 
 
4. Are you currently consuming any supplements? 
 
 
 
 
Yes [  ] 
No [  ] 
(What, when, dose, manufacturer/brand) 
 
5. Are you currently on any medication? 
 
 
 
 
 
Yes [  ] 
No [  ] 
(What, when, dose, manufacturer/brand) 
 
Participant information, anthropometry and body composition 
Gender 
(tick one) 
DOB 
(DD/MM/YY) 
Blood pressure 
Waist circ. 
Hip circ. 
 
M[   ]   F[   ] 
 
___/____/____ 
 
_______mmHg 
 
________cm 
 
_______ cm 
 
Weight 
 
Height 
 
BMI 
 
Impedance 
 
Resistance 
 
_____kg 
 
_______ cm 
 
________kg/m2 
 
 
 
24 hour dietary recall 
1. Is this a typical day? Please tick [√] one.  
 
 
 
 
Yes [  ] No [  ] 
If not, give an example of a typical day after yesterday’s record if you wish. 
 
E.g. 
Time 
Quantity eaten 
Details of food and drink 
7:15am 
1 cup 
Tea 
 
 
Milk 
 
1½ teaspoons  
White sugar 
 
½ glass 
Water 
10am 
1 mug 
Wheat porridge 
 
2 
Medium sized yellow sweet potatoes (boiled) 

38 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Blood draw 
 
Time of catheter introduction: ______ 
 
Time of first blood draw: _______ 
 
Start of test food consumption: _______ 
 
Completion 
of 
test 
food 
consumption: 
_______  
 
 

39 
 
Appendix 3: VAS in assessment of appetite sensations 
 
 
How hungry do you feel? 
 
Not at all hungry 
 
Extremely hungry 
 
 
How full do you feel? 
 
Not at all full 
 
Extremely full 
 
 
How satiated are you? 
 
Not at all satiated 
 
Extremely satiated 
 
 
How strong is your desire to 
eat? 
 
Not at all strong 
 
Extremely strong 
 
 
How much could you eat right 
now? 
 
Nothing at all 
 
A very large amount of food 
 
 
Would 
you 
like 
to 
eat 
something sweet? 
 
Yes, very much 
 
No, not at all 
 
 
Would 
you 
like 
to 
eat 
something salty? 
 
Yes, very much 
 
Yes, very much 
 
 
Would 
you 
like 
to 
eat 
something fatty? 
 
Yes, very much 
 
Yes, very much 
 
 
Hunger: A compelling need or desire for food; the painful sensation or state of weakness caused 
by the need of food 
 
Satiety: Fullness that persists after eating; length of time until next eating occasion

40 
 
Appendix 4: CVs of Team Members 
CV of Dr. Florence Kyallo 
 
Proposed Position in Research: 
PI 
Proposed role in the study: 
PI 
Organisation: 
Jomo Kenyatta University of Agriculture and Technology, 
Kenya 
Name of Staff: 
Dr. Florence Mumbi Muthiani Kyallo 
Profession: 
Nutritionist and Lecturer 
Date of Birth: 
 
Years with Organisation:  
13 
Nationality: 
Kenyan 
Membership in Professional Societies: 
 Kenya Nutritionists and Dieticians' Institute (KNDI) 
 Member of technical working groups at the Ministry 
of Health in Kenya (Nutrition and HIV, Agri-
Nutrition and Healthy Diets 
Detailed Tasks Assigned in Project: 
 Budget Preparation and Management 
 In charge of and accountable for activities on in the 
research project. 
 Reporting and dissemination 
 Proposal development and submission 
 Ensure compliance proposal to regulatory 
requirements 
 Responsible for the overall scientific, fiscal, and 
administrative conduct of the research 
Education & Qualifications: 
Qualification 
Awarding Institution 
Country 
Year 
Doctor of Philosophy in Applied 
Human Nutrition 
University of Nairobi 
Kenya 
2013 
Master of Science in Applied 
Human Nutrition 
University of Nairobi 
Kenya 
2005 
 
 
 
 
 
 
 
 
 
Employment Record: 
From (year)  To (Year) 
Position 
Employer 
2006 
Present 
Academic (Lecturer, 
Support Lecturer, 
Assistant lecturer) 
Jomo Kenyatta University of 
Agriculture and Technology 
(JKUAT), Kenya. 
2004 
2005 
EUREPGAP Inspector 
Africert Limited, Nairobi. 
2004 
2005 
Academic (Lecturer, 
Curriculum Developer) 
Eastern Institute for Health 
Research and Training, Nairobi. 
1995 
1997 
Agriculturalist, Project 
manager 
Tana and Athi Rivers 

41 
 
Development Authority 
(TARDA). 
Summary of research experience: 
 2012-2016: Development of a nutritious composite flour from pearl millet (Pennisetum glaucum) 
and pumpkin (Cucurbita pepo-variety styriaca) (with Kindiki Maryanne and Dr. Arnold Onyango) 
 2014 to Date: Development of elearning courses for nutrition education and counseling, and 
Nutrition in Emergency Situations. Project funded by EU-Edulink in collaboration with German, 
Ethiopian, Ugandan and Kenyan Universities. 
 2013-date: Effect of school feeding on nutritional status of pre-school children in Ganze Division 
of Kilifi County, Kenya. (with Mungai Beatrice) 
 2013-Date: A case control study of clinical and socio-demographic risk factors associated with 
severe acute malnutrition (sam) among children admitted at Lubango hospital-Angola (with Ketha 
F) 
 Jan 2012-2014: Nutritional Vulnerability of People Living With HIV and AIDS in Kenya. A 
collaboration between Kenya Medical Research Institute (KEMRI), National AIDS aand STI 
control Programme (NASCOP), World Food Programme (WFP). 
 2007 – 2012: The Impact of Nutrition Education on overweight and obesity and the associated risk 
factors and among school children aged 9-14 years in Nairobi, Kenya. 
 2011 – 2013: Effect of Soy bean based diets on nutrition status of children below five years in 
Rwanda. A collaboration between Rwanda Agricultural Board, RUFORUM and JKUAT. 
 June 2009 – 2011: Committee member, HENNA project on Harmonization of Applied Human 
Nutrition curricula within Eastern Africa Universities. A collaboration between JKUAT, 
University of Nairobi and Egerton University in Kenya, Hawassa University in Ethiopia, Makerere 
University in Uganda, University of Ulm and Giessen University in Germany. (Project funded by 
EU) 
 2008: Trainer, developing Monitoring and Evaluation systems, Kenya HIV/AIDS Business 
Council (KHBC), Nairobi 
 February – April 2007: Co-researcher. The Role of Probiotics in the Health and Nutrition of the 
Maasai of Kajiado District, Kenya. A collaboration between JKUAT and FriedrichSchiller-
University, Germany. 
 2003 - 2005: Danida - Community Based Nutrition Programme, Nairobi. Consultant on 
Monitoring and Evaluation of Nutrition Interventions and Food Security Projects. Was involved in 
data collection, data analysis and report writing of nation-wide and regional surveys including 
household baseline and follow up surveys and orphan surveys carried out in 13 districts in Kenya. 
 April - July 2003: Research assistant. Food Consumption, Vitamin A and Nutritional status of 
children 6 - 59months in Machakos district, Kenya. A study conducted under the Applied 
Nutrition Programme, University of Nairobi. 
  March - February 2003: Research assistant. Food Security, Health and Nutritional Status of 
Under-Fives in Kisii District, Kenya. A survey carried out by the Applied Nutrition Programme, 
University of Nairobi. 
Publications: 
 2016: Abdikadir S. Omar, Joseph K. Mutai, Florence M. Kyallo, Musa Otieno Ngayo. Family 
planning utilization and correlates; perspective of women aged 15-49 years from Mandera County 
of North Eastern Kenya. Journal of Health, Medicine and Nursing Vol.26, 2016 156-168.  

42 
 
 2015: Maryann Mukethi Kindiki, Arnold Onyango, Florence Kyallo: Effects of Processing on 
Nutritional and Sensory Quality of Pearl Millet Flour. Food Science and Quality Management 
Vol.42, 2015 13-20. 2014: Niyibituronsa M, Kyallo F, Mugo C and Gaidashova. The Effects of 
Household Food Practices and Diseases Prevalence on Nutritional Status of Under-Five Children in 
Ruhango District, Rwanda 2014: Niyibituronsa M, Kyallo F, Mugo C and Gaidashova. Improving 
the nutritional status of Malnourished Chldren in Rwanda. AJFAND 14:4. 
 2013: Kyallo F.M., Mwangi A.M.M and Makokha A.O. (2013). Overweight and Obesity among 
Public and Private school children in Nairobi, Kenya. Health.  
 2012: Catherine Wachuka Mutie and Florence Kyallo (2012). Empowering Women Through Better 
Healthcare and Nutrition: The Case of Kenya: In Empowering Women Through Better Healthcare 
and Nutrition in Developing Countries. The Centre for Science and Technology of Non-Aligned 
and Other Developing Countries (NAM S&T Centre), India Page 151-160. 
 2012: Louise Ngugi, Jasper Imungi, Jaswant Sehmi and Florence Kyallo (2012). Knowledge on and 
Consumption of Traditional Green Leafy Vegetables among 13-14 year olds – A Case Study of two 
Primary Schools in Peri-Urban Nairobi. Paper presented at the 24th Nutrition Congress Africa 01-
04 October 2012 Bloemfontein, South Africa.  
 2011: Andere N.A and Kyallo F.M. (2011). Nutritional Status, Nutrition Knowledge and Attitudes 
of students in Jomo Kenyatta University of Agriculture and Technology. Paper presented at the 
Jomo Kenyatta University of Agriculture and Technology Conference, October 2011.  
 2011: Nadja Knoll, Katrin Kuhnt, Florence M. Kyallo, Beatrice N. Kiage-Mokua, and Gerhard 
Jahreis. High content of long-chain n-3 polyunsaturated fatty acids in red blood cells of Kenyan 
Maasai despite low dietary intake. Lipids in Health and Disease. 10:141.  
 2010: Kyallo F.M., Mwangi A.M and Makokha A.O. Demographic and socioeconomic 
determinants of overweight and obesity among school children in Nairobi. Paper presented at the 
4th ANEC Conference. Safari Park Hotel, Nairobi.  
 2010: Kyallo F.M. Imungi J.K. Sehmi J. and Ngugi L.W. Utilization of Traditional Leafy Vegetables 
in Kalama Division, Machakos, Kenya. Paper Presented at the 2nd ITROMID Scientific 
Conference. AICAD, Kenya. 25-28th May 2010. 
 2010: Macharia-Mutie C.M and Kyallo F.M. Empowering Women Through Better Healthcare and 
Nutrition; Preliminary Findings of the 2008-9 Kenya Demographic and Health Survey (KDHS). 
Paper presented at the International Conference on Empowering Women in Developing countries 
Through Better Heathcare and Nutrition. BITS Pilani, Rjasthan, India on 22-24th April 2010.  
 2009: Kyallo F.M., Mwangi A.M. and Makokha A.O. Obesity among School Children In Nairobi. 
Paper presented at the UNICEF Nutrition Research Symposium. Pan Afric Hotel, Nairobi. 29-30th 
June 2009. 2009: Kyallo F.M., Mwangi A.M. and Makokha A.O. Nutrition Status of School children 
In Nairobi. Paper presented at the 3rd East African Health and Scientific Conference. KICC. 
Nairobi, Kenya on 27-29th March 2009. 
 
Language proficiency: 
 
Language 
Speaking 
Reading 
Writing 
English 
Proficient 
Proficient  
Proficient 
Swahili 
Proficient 
Proficient 
Proficient 
German 
 
 
 
Kikamba 
Proficient 
 
 
 

43 
 
I, FLORENCE KYALLO, certify that the information provided here in is correct to the best of 
my knowledge as of (____/_____/2019). 
 
 

44 
 
CV of Prof. dr. Christophe Matthys 
 
Proposed Position in Research: 
PI 
Proposed role in the study: 
PI 
Organisation: 
UZ Leuven/ KU Leuven 
Name of Staff: 
Christophe Matthys 
Profession: 
Professor 
Date of Birth: 
05th March, 1975 
Years with Organisation:  
8 
Nationality: 
Belgian 
Membership in Professional Societies: 
 Member of the Scientific Committee of the Belgian 
Food Consumption Survey 
 Member of the Scientific Committee of the Belgian 
Federal Agency for the Safety of the Food Chain 
(2013 – present) 
 Member of the Working Group on Food Additives of 
the European Food Safety Authority (2013 – 2014) 
 Member of the scientific Committee of the VITADEK 
study (2014 – present) 
 Member 
of 
the 
scientific 
Committee 
of 
the 
Sweeteners-study conducted by the Belgian Institute 
of Public Health (2015) 
 Member of the scientific Committee of the Belgian 
Nutrition and Health Conference 
 Member of the editorial board of the Nutrition 
Bulletin and Food Science & Law 
 Member of the European Nutrition Leadership 
Platform 
 Founding member and active member of the Belgian 
Nutrition Society 
 Member of the Vlaamse Vereniging voor Klinische 
Voeding en Metabolisme 
 Member of the Belgian Endocrine Society 
Detailed Tasks Assigned in Project: 
 Budget Preparation and Management 
 In charge of and accountable for activities on in the 
research project. 
 Reporting and dissemination 
 Proposal development and submission 
 Ensure compliance proposal to regulatory 
requirements 
 Responsible for the overall scientific, fiscal, and 
administrative conduct of the research 

45 
 
Education & Qualifications: 
Qualification 
Awarding Institution 
Country 
Year 
PhD in Medical Sciences, Faculty of 
Medicine and Health Sciences 
Ghent University 
Belgium 
 
Master of Bioscience Engineering - 
option Tropical Agriculture  
Ghent University 
Belgium 
 
Continuing Education: several courses in statistics, epidemiology, leadership skills and management 
skills in technology transfer, education courses on teaching at university level 
 
 
 
 
Employment Record: 
From (year)  
To (Year) 
Position 
Employer 
October, 2011 
2017 
Academic (Assistant 
Professor, Scientific Co-
ordinator) 
KU-Leuven, Leuven, Belgium 
April, 2009 
September, 2011 
Senior Scientific Project 
Manager  
ILSI Europe, Brussels, Belgium 
July 2008 
March 2009 
Post-doctoral Researcher 
 
Ghent University, 
Belgium 
July, 2007 
May, 2008 
Lecturer 
Institute of Food, Nutrition and 
Human Health, Massey 
University, New Zealand 
August 2005 
July, 2007 
Assistant Academic Staff 
Ghent University, Belgium 
September, 
1998 
July, 2005 
Research Staff 
Ghent University, Belgium 
Summary of research experience: 
Christophe Matthys has (inter)national research experience in the different domains of human nutrition (eg 
food consumption and nutrition surveys, nutrition policy and public health nutrition, nutritional 
epidemiology, experimental studies in nutritional epidemiology, food safety). 
 
From an international perspective, he is currently collaborating with several universities in the context of 
research and education projects. There is a stong contact with the following universities: Muhumbili 
University (Dar Es Salaam, Tanzania), Stellenbosch University (Stellenbosch, South Africa), Massey 
University, (Palmerston North, New Zealand) and University of Bergen (Bergen, Norway). 
 
Publications: 
https://lirias.kuleuven.be/cv?u=U0076391  
 65 publications in international peer-reviewed journals  
 >100 presentations at national and international conferences - number of citations: 875 – without 
self-citation: 840 (January 2016)  
 h-index: 19 (January 2016) 
Language proficiency: 
 
Language 
Speaking 
Reading 
Writing 
English 
Fluent 
Fluent 
Fluent 
Dutch 
Fluent 
Fluent 
Fluent 

46 
 
French 
Good 
Good 
Moderate 
German 
Moderate 
Moderate 
Moderate 
Spanish 
Moderate 
Moderate 
Moderate 
 
I, CHRISTOPHE MATTHYS, certify that the information provided here in is correct to the 
best of my knowledge as of (___/____/2019). 
 
 
 
 

47 
 
CV of Dr. Beatrice N. Kiage 
 
Proposed Position in Research: 
Co-I 
Proposed role in the study: 
Co-I 
Organisation: 
Jomo Kenyatta University of Agriculture and Technology, 
Kenya. 
Name of Staff: 
Beatrice N. Kiage 
Profession: 
Lecturer 
Date of Birth: 
26th February, 1976 
Years with Organisation:  
7 
Nationality: 
Kenyan 
Membership in Professional Societies: 
Member of the Kenya Nutritionists and Dieticians Institute 
(KNDI) 
 
Board member in the board of post graduates studies in the 
Faculty of agriculture at JKUAT 
 
Departmental quality assurance member in the Department of 
Food Science and Technology at JKUAT 
Detailed Tasks Assigned in Project: 
Supervise the doctoral student in research activities related to: 
 
Data collection  
Handling of raw data 
Statistical analysis  
Publications and oral, poster and seminar presentations 
Study results dissemination stakeholders 
Education & Qualifications: 
Qualification 
Awarding Institution 
Country 
Year 
PhD. Nutritional Biochemistry/ 
Dietetics 
Kiel 
Germany 
2013 
M.Sc. Food, Nutrition and Dietetics 
Kenyatta University 
Kenya 
2005 
M.Sc. Food, Nutrition and Dietetics 
Kenyatta University 
Kenya 
1999 
 
 
 
 
Employment Record: 
From (year)  To (Year) 
Position 
Employer 
2013 
Present 
Lecturer 
Jomo Kenyatta University of 
Agriculture and Technology 
2010 
2013 
Doctoral Researcher 
Max Rubner Institute 
2006 
2013 
Assistant Lecturer 
Jomo Kenyatta University of 
Agriculture and Technology 
2006 
2013 
Part time Lecturer 
Kenyatta University 
2000 
2005 
Graduate Student 
Researcher & 
Nutritionist/Dietician 
Kenyatta University & Kenyatta 
National Hospital 

48 
 
Summary of research experience:  
2008-2014: Graduate Student Researcher, Kenyatta National Hospital surgical wards 
• Research focused primarily adult patients admitted to the ward for abdominal surgery 
• Techniques used to determine nutritional status included 24/hour recall, diet history, food 
frequency, anthropometric assessments :height, weight, BMI, waist circumference, skin fold callipers, 
and laboratory measurements of serum albumin levels and serum creatinine levels 
• Demonstrated strong data collection/analysis, problem solving, written and verbal skills through 
thesis and scientific presentations 
 
2010-2013:Doctoral Researcher, Max Rubner Institute, Kiel, Germany 
• Conducted in vitro and in vivo studies using plant extracts to treat obesity, diabetes and 
metabolic syndrome and other cardiometabolic disorders 
• Analysed large data sets using exploratory, descriptive and multivariate analysis techniques 
Processed and analysed large datasets using SPSS, SAS and R 
• Planned and coordinated laboratory experiments and animal trials and interpreted results 
• Provided oral explanations of my data analysis at several local, national, and international 
scientific conferences 
• Prepared manuscripts for submission to scientific journals 
• Assisted in the development of a randomized clinical trial which is ongoing at CRC, Kiel, Germany 
Research at Kajiado, Kenya 
• Assisted in writing the proposal 
• Conducted household surveys of the Maasais 
• Collected food samples from the households 
• Assisted with manuscript preparation for publication 
Publications: 
In Vitro Anti-Diabetic Activities and Phytochemical Analysis of Bioactive Fractions Present in Meriandra 
dianthera, Aloe camperi and a Polyherb. Mussie Sium, Patrick Kareru, Beatrice Kiage-Mokua, Kaushal 
Sood, John Langley, Julie Herniman. 2017. American Journal of Plant Sciences 8: 533-548. 
 
Effect of soaking and germinating techniques on the macronutrient content of Hyptis spicigera Lamiaceae 
seeds in Morobo County, South Sudan. Grace Ayite Banja, Kiage-Mokua Beatrice and Okoth Judith 
Kanensi1. 2016. Sky Journal of Food Science 5(3), 019-023. 
 
Lapacho Tea (Tabebuia impetiginosa) Extract Inhibits Pancreatic Lipase and Delays Postprandial 
Triglyceride Increase in Rats. Kiage-Mokua BN, Roos N, Schrezenmeir J. 2012. Phytotherapy Research 
26: 1878-1883. 
 
High content of long-chain n-3 polyunsaturated fatty acids in red blood cells of 
Kenyan Maasai despite low dietary intake.Knoll N,Kuhnt K,Kyallo FM, Kiage- Mokua BN,Jahreis G. 
2011. Lipids in Health and Disease 10: 141. 
 
Published a chapter on nutrition in a book by African Medical Research Foundation (AMREF) on “Non‐
communicable Diseases”. 2006 
 
The effect of Nutritional Status on Clinical outcome of abdominal Surgery patients at Kenyatta National 
Hospital, Kenya. Published at the graduation proceedings of Kenyatta University (14th October 2005). 

49 
 
2005 
Language proficiency: 
 
Language 
Speaking 
Reading 
Writing 
English 
Fluent 
Fluent 
Fluent 
Kiswahili 
Fluent 
Fluent 
Fluent 
German 
Fluent 
Fluent 
Fluent 
 
 
I, BEATRICE N. KIAGE, certify that the information provided here in is correct to the best of 
my knowledge as of (____/____/2019). 
 
 

50 
 
 
CV of Prof. Dr. Bart Van der Schueren 
 
Proposed Position in Research: 
Co-I 
Proposed role in the study: 
Co-I 
Organisation: 
KU Leuven 
Name of Staff: 
Bart Van der Schueren 
Profession: 
Associate professor 
Date of Birth: 
 
Years with Organisation:  
8 
Nationality: 
Belgian 
Membership in Professional Societies: 
• The Committee for Medicinal Products for Human Use (CHMP) at the 
European Medicines Agency (EMA)from Sep 2013 – Present 
• Belgian Alternate Member from Sep/2013 to Sep/2016; 
• Belgian Member from Sep/2016 to date; 
• Rapporteur for 4 products/year in the field of endocrinology, vaccines 
and oncology; 
• Member of the Cardiovascular Working Party 
Detailed Tasks Assigned in Project: 
Co-promoter of the doctoral student for doctoral studies 
Education & Qualifications: 
Qualification 
Awarding Institution 
Country 
Year 
PhD degree 
 
 
 
Master's degree 
KU Leuven  
Belgium 
2002 
Bachelor's degree 
Facultes universitaires 
Notre-Dame de la Paix 
 
1998 
 
 
 
 
Employment Record: 
From (year)  
To (Year) 
Position 
Employer 
2011 
Present 
Professor Dr in 
endocrinology/ Associate 
professor 
University Hospital Leuven/ KU Leuven  
2010 
2011 
Postdoctoral \fellow 
Columbia University College of 
Physicians and Surgeons/ Belgium 
American Educational Foundation 
Summary of research experience: 
 
Publications: 
Scientific output: 75 publications in the field of obesity and bariatric surgery (h-index 16; 721 citations);  
Language proficiency: 

51 
 
Language 
Speaking 
Reading 
Writing 
English 
Fluent 
Fluent 
Fluent 
Dutch 
Fluent 
Fluent 
Fluent 
 
 
 
 
 
I, (name), certify that the information provided here in is correct to the best of my knowledge as of (dd/m/yr). 
 
 

52 
 
CV of Linet N. Mutwiri 
 
Proposed Position in Research: 
PhD student 
Proposed role in the study: 
Co-I 
Organisation: 
Meru University of Science and Technology, Kenya. 
Name of Staff: 
Linet Nkirote Mutwiri 
Profession: 
Human Nutritionist and Tutorial Fellow 
Date of Birth: 
14th August, 1988 
Years with Organisation:  
7s 
Nationality: 
Kenyan 
Membership in Professional Societies: 
KNDI 
Detailed Tasks Assigned in Project: 
Preparation of a PhD thesis: Literature study; collection of data 
and samples and making analyses; studying methodologies to 
analyse and interpret study results; conclude research results.  
 
Defence of a PhD thesis about the research process to a scientific 
jury 
 
Networking at congresses and scientific for a of our research 
field; present our “work in progress”; get feedback; build a 
network of contacts 
 
Publishing in scientific journals; dissemination of study findings 
to stakeholder platforms 
Education & Qualifications: 
Qualification 
Awarding Institution 
Country 
Year 
PhD. Biomedical Science 
Jomo Kenyatta 
University of 
Agriculture and 
technology & 
Katholieke Universiteit 
Leuven 
Kenya & Belgium 
2017-
Present 
Msc. Human Nutrition and Rural 
Development-main subj. Human 
Nutrition 
Ghent University 
Belgium 
2015 
Bsc. Food Science and Nutrition 
Jomo Kenyatta 
University of 
Agriculture and 
Technology 
Kenya 
2012 
 
 
 
 
Employment Record: 
From (year)  To (Year) 
Position 
Employer 
2013 
Present 
Academic (Teaching 
Assistant, Tutorial 
Fellow) 
Meru University of Science and 
Technology 

53 
 
2012 
2013 
TOT 
Aphia Plus KAMILI-Upper 
Eastern Region 
 
 
 
 
 
 
 
 
Publications: 
Dietary Practices and Disease Management Practices in Diabetes' Patients with Good and Poor Glycemic 
Control at Kenyatta National Hospital (Published in Ghent University Library, 2015) 
Summary of research experience:  
I have conducted field research work, facilitated community training programs and dissemination at 
community level while attached to Kenya Red Cross Society and APHIA-Plus KAMILI (now defunct). 
 
I have also collected research for my project and dissertation at both undergraduate and graduate study level 
respectively. 
Language proficiency: 
 
Language 
Speaking 
Reading 
Writing 
English 
Proficient 
Proficient  
Proficient 
Swahili 
Proficient 
Proficient 
Proficient 
Kimeru 
Proficient 
Good 
Elementary 
 
I, LINET N. MUTWIRI, certify that the information provided here in is correct to the best of 
my knowledge as of (____/____/2019).

54 
 
Appendix 6: Ethics Training Certificates 
 
Ethics Training Certificate for Dr. Florence Kyallo 
 

55 
 
Ethics Training Certificate for Prof. dr. Christophe Matthys 
 
 

56 
 
Ethics Training Certificate for Dr Beatrice Kiage 
 
 

57 
 
Ethics Training Certificate for Linet Mutwiri 
 
 
 

58 
 
Ethics Training Certificate for Prof. Bart van der Schueren 

59 
 
Appendix 7: Adherence measures COVID 19 prevention and control regulations (adopted 
from Ministry of Health, Kenya) 
Considering that the COVID-19 disease has now been classified as a pandemic we are taking the 
following precautionary measures during research activities: 
1. Regular and thorough washing of hands with soap and water, or alcohol-based hand sanitizer 
provided by the researches. 
2. Maintaining a distance of at least 1 meter (5 feet) between yourself and anyone (who is coughing 
or sneezing), avoiding handshakes or hugging. 
3. Persons with a cough or sneezing should stay home or keep a social distance, but avoid mixing 
with others in a crowd. 
4. Maintain good respiratory hygiene by covering your mouth and nose while coughing and 
sneezing with a handkerchief, tissue, or into flexed elbow. 
5. Stay at home if you feel unwell with symptoms like fever, cough and difficulty in breathing. 
6. All study participants should at all times wear a face mask to reduce the chances of transmission 
of the virus. 
7. Any cases regarding the disease will be reported using the call line facility number 719. Correct 
messages to be relayed to the participants (if need be) will be received from *719# 
8. Surfaces used during the research activities (e.g. desks, tables) and objects will be wiped with 
disinfectant regularly.