Effect of Flaxseed Consumption as a Treatment for Adults With Type 2 Diabetes Mellitus in Oaxaca de Juárez, Oaxaca
Phase: NA
Conditions: DIABETES Mellitus Type 2 Not Well Controlled
Sponsor: Universidad Autónoma Benito Juárez de Oaxaca

May 30, 2023 
 
 
UNDER THE LEADERSHIP OF: DR. SABINA LÓPEZ TOLEDO
University of the Southern Sierra

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
University of the Southern Sierra 
 
Effect of flaxseed consumption as a treatment 
for adults with type 2 Diabetes Mellitus in 
Oaxaca de Juarez, Oaxaca. 
 
 
 
I. PRESENTATION OF THE PROTOCOL OR RESEARCH PROJECT 
 
1. Summary of the study  
Introduction: Type 2 Diabetes Mellitus represents one of the most important health 
emergencies of this century. It is estimated that by 2045 there will be 700 million people 
living with diabetes. Flaxseed is a food that is characterized by its nutritional properties, 
highlighting its content of alpha linoleic acid, flax lignans, digluc- secoisolariciresinol 
cosides. The latter have antioxidant, hypolipidemic and hypoglycemic effects, which makes 
it an excellent option as a functional treatment for type 2 diabetes. 
Material and Method: Randomized clinical trial. The sample will be recruited by self-
selection. 
The control group will be given a nutritional education talk using the healthy eating plate and 
the group intervention you will be prescribed flaxseed supplementation (16 gr of 
flaxseed/day for three months) and also a talk of nutritional education using the healthy 
eating plate. A clinical history will be applied for the variables age, gender, occupation and 
marital status, duration of the disease, type of current diabetes treatment, control and 
comorbidities, weight, height and biochemical parameters glucose, glycosylated 
hemoglobin, total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol of each 
participant, at the beginning and at the end of the study. 
 
Scientific/Practical Relevance: The use of flaxseed as a functional food for the treatment 
of type 2 diabetes is It has been used in different populations with success. However, in the 
state of Oaxaca its effectiveness has not been tested despite having this food available. If 
the results are positive, this food can be offered as a therapeutic alternative instead of or in 
combination with its pharmacological treatment, improving the results. This is important 
because the prevalence of this disease in the state is increasing. 
Keywords: Type 2 Diabetes Mellitus, treatment, functional food, Flaxseed. 
 
 
 
 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
Expected start and completion dates of the study. 
Start: October 2023 
Study completion: March 2025 
 
2. Objectives  
 
 
General 
 
• To assess the adjuvant effects of flaxseed consumption (16 g of flaxseed per day/3 
months) on 
Biochemical factors (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL 
cholesterol and cholesterol HDL) of adult patients (30 to 70 years) with type 2 diabetes 
mellitus, who attend the Nutrition outpatient clinic from the Regional Hospital of Oaxaca. 
 
 
Specific Objectives 
1. Describe the sociodemographic variables (age, sex, occupation, marital status) of 
adult patients (30 to 70 years) who suffer from type 2 diabetes, who attend the Nutrition 
outpatient clinic at the Regional Hospital from Oaxaca. 
2. Describe the clinical characteristics (time of evolution of the disease, type of 
treatment, control and comor- bilities), of adult patients (30 to 70 years) who suffer 
from type 2 diabetes, who attend the outpatient clinic of Nutrition at the Regional 
Hospital of Oaxaca. 
3. Assess the anthropometric variables (weight and height) of adult patients (30 to 70 
years) who suffer from diabetes type 2, who attend the Nutrition outpatient clinic at the 
Regional Hospital in Oaxaca. 
4. Evaluate the biochemical parameters (glucose, glycosylated hemoglobin, total 
cholesterol, triglycerides, LDL cholesterol and HDL cholesterol) of adult patients (30 to 
70 years) suffering from type 2 diabetes, who attend the Nutrition outpatient clinic of 
the Regional Hospital of Oaxaca, prior to the consumption of flaxseed and three months 
after regular consumption of flaxseed. 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
5. Apply a nutritional intervention to two groups: Group A) Teaching the healthy 
eating plate and Group B) Teaching healthy eating dishes and indicating 
flaxseed consumption. 
6. Evaluate the effect of flaxseed consumption on biochemical markers (glucose, 
glycosylated hemoglobin, 
Total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol of adult patients 
(30 to 70 years) suffering from type 2 diabetes, who attend the Nutrition outpatient clinic 
at the Regional Hospital in Oaxaca. 
7. Analyze the most effective possible combinations (pharmacological + non-
pharmacological) for the treatment of Adult patients (30 to 70 years) who suffer from 
type 2 diabetes, who attend the Nutrition outpatient clinic at the Regional Hospital of 
Oaxaca. 
 
4. Justification 
 
 
Type 2 Diabetes Mellitus represents one of the most important health emergencies 
of this century. It is estimated that In 2019, there were already 463 million people 
with diabetes mellitus worldwide and this figure may increase to 578 million by 2030 
and to 700 million by 2045. A state of hyperglycemia is associated with acute and 
chronic complications, in both cases affecting the cardiovascular system, mainly 
the blood vessels and consequently to the entire organism, but mainly to the eyes, 
kidneys, arteriovelocity systems. and peripheral nerves. Although it is known that 
insulin resistance is reversible and that diabetes mellitus type 2 is controllable with 
a 
change 
towards 
a 
healthy 
lifestyle, 
the 
population 
ignores 
these 
recommendations and continue with their unhealthy habits. Thus, the number of 
patients continues to grow exponentially, which leads to an increase in economic 
expenditure in terms of health. This is why non-pharmacological measures are 
sought that favor the reduction of glycemia in patients with Diabetes Mellitus where 
the consumption of functional foods is a good alternative for the treatment of this 
chronic disease (Tinajero et al., 2021; Wu et al., 2014). Flaxseed is a food 
characterized by its nutritional properties, highlighting its content of alpha linoleic 
acid, flax lignans, and secoisolariciresinol diglucosides. The latter have antioxidant, 
lipid-lowering and hypoglycemic effects, which makes it an excellent option as a 
dietary supplement for treatment of type 2 diabetes (Parikh et al., 2019). 
 
Some studies have been conducted with flaxseed supplementation. In a 
randomized cross-sectional study conducted by Tharwat et al., in 2017, evaluated 
90 patients with type 2 Diabetes Mellitus with a range of 5 to 7 years of diagnosis 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
that they received oral hypoglycemic agents (metformin 500 mg) 3 times a day, 
having an age range between 35 and 45 years old. They divided the population into 
3 groups:  
Group 1 selected 30 patients with a calculated diet to 1350kcal (in the form of 50% 
carbohydrates, 30% fat and 20% protein) without flaxseed supplementation. 
Group 2 included 30 patients with the same diet, but adding linseed oil for 6 days a 
week in an amount of 13g/day. And in group 3, 30 patients were included in the 
same dietary regimen that group 1, adding flaxseed flour to their diet for 6 days a 
week, providing 32g of flaxseed per day. They concluded that in the 3 groups there 
was a reduction in blood glucose, however the decrease in glucose in Fasting 
reported by group 3 had better target figure achievements (Tharwat., 2017). 
In a systemic review in 2018 Mohammadi et al, evaluated 25 randomized clinical 
trials, presenting a significant association between flaxseed supplementation and 
a reduction in blood glucose. It is worth mentioning that This relationship was more 
significant in the groups in trials that used ground flaxseed and reported an admin- 
Administration between 4 to 14 grams. (Mohammad., et al, 2018) 
Hasaniani et al in 2019 conducted a randomized, controlled clinical trial with 57 
patients with Diabetes Mellitus type 2. He divided his population into 2 groups. One 
group was prescribed 200g of natural yogurt in their diet and the other Another 
group was also prescribed 200g natural yogurt with 30g of flaxseed added for 8 
weeks documented a significant reduction in hemoglobin A1c (p=0.001) compared to 
the control group (Ha-saniani, 2019). In another study, Nowrk concluded that regular 
consumption of flax seed improves the lipid profile by reducing triglycerides and total 
cholesterol and increasing HDL cholesterol (Nowak & Jeziorek.,2023) 
 
 
5. Design of the research methodology. 
 
Randomized clinical trial (case-control). 
 
The sample will be recruited by self-selection. 
 
The total number of recruited participants will be divided into two groups (A and B). 
The control group will be given a talk nutritional education using the healthy eating plate 
and the intervention group will be instructed on supplementation 
with flaxseed (16 gr of flaxseed/day for three months) and also a nutritional education talk 
using the plate 
of good eating. 
 
Once they sign the legal informed consent for participation, a clinical history will be applied 
where 
 
Sociodemographic variables such as age, sex, occupation and marital status will be 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
asked. Clinical characteristics such as time since the disease has been on the disease, 
type of current diabetes treatment, control and comorbidities will also be asked. These 
variables will be collected at the beginning of the research and only once during the 
study. 
The nutritionist will take the participant's weight and height and record them at the 
beginning and end of the study. 
 
Specialized nurses will take 5 milliliters of blood in the clinical laboratory area of the 
Regional Hospital 
 
from the of Oaxaca and a clinical chemist professional will assess the biochemical 
parameters glucose, hemoglobin glycosylated, total cholesterol, triglycerides, LDL 
cholesterol and HDL cholesterol of each participant, at the beginning and at the end of the 
study (after three months of intervention, consuming 16 g of flaxseed/day). 
The effect of flaxseed consumption on biochemical markers (glucose, hemoglobin) will 
subsequently be evaluated. 
 
glycosylated, total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol and the 
possible combinations will be analyzed (pharmacological + non-pharmacological) most 
effective for the treatment of type 2 diabetes. 
6. Selection criteria and description of participants. 
Selection criteria 
 
Patients living with type 2 Diabetes Mellitus and who come with fasting blood glucose 
greater than 140 and hemoglobin glycosylated greater than 6.5%, who are 
beneficiaries who attend the Nutrition outpatient clinic of the 
Hospital-Regional “Presidente Benito Juárez” diagnosed at most one year ago and who 
agree to participate in 
 
the study, age between 45 and 65 years with regular attendance at the outpatient clinic, 
minimum of 3 consecutive months. 
 
 
7. Methods of selection and inclusion of participants in the study. 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
Phase 1. Sample recruitment. 
 
The convenience sample will be recruited by self-selection: patients who 
attend the nutrition outpatient clinic tion that meet the inclusion criteria, 
they will be invited to participate in the study. After giving them 
all information, those who wish to participate will sign the legal informed consent for 
participation. 
Phase 2. Case randomization procedure. 
 
Patients who sign the informed consent will be assigned a group according to the following: 
in the case 
 
If you have an even number in your file, you will be part of the control group (A), and 
if you have an odd number, you will be part from intervention group B. 
Group A. 
 
They will be given verbal instructions to continue with the treatment established by the 
treating physician, and they will be provided with nutritional guidance with the help of the 
healthy eating plate. 
 
Group B. 
 
They will be given verbal instructions to continue with the treatment established by the 
treating physician, they will be given nutritional guidance with the help of the healthy eating 
plate and they will be provided with a pamphlet with the instructions. 
written and photographed on how to consume flaxseed and its benefits. 
Phase 3. 
 
Administration of flaxseed 
 
Researchers will purchase, package, and provide flaxseed powder to members of group B. 
 
Flaxseed will be delivered in packages with 16 gr of ground flaxseed each, 
which will be given to patients for their daily consumption (a tablespoon of 8 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
gr of flaxseed in the morning snack and 8 gr of flaxseed in the afternoon 
snack) 
(late). You will be provided with brochures with images explaining how to consume it 
and how the glass should look when finished. Various forms of consumption of the 
powder will also be provided to avoid getting bored with the taste and consistency. 
from dust. 
Phase 4. 
 
Surveillance and monitoring. 
 
Daily contact will be maintained with participants via WhatsApp in order to remind them to 
take flaxseed. 
 
and also to find out if they have any adverse symptoms (abdominal 
distension, flatulence, gas, diarrhea, etc.), as well as to resolve doubts and 
ask if they should start taking some vitamins, minerals or medications. 
Both groups will be given a 24-hour recall and a food frequency questionnaire. 
 
every 15 days. The food consumption of both groups will be analyzed according 
to its nutritional content (energy, macro and micronutrients) and each nutrient 
will be used as a nutritional variable that can influence the control of the 
biochemical markers. 
Phase 5. 
 
Data analysis. 
 
 
Statistical analysis will be performed using the IBM SPSS Statistics program version 
24, in which it will be performed descriptive statistics and for group comparisons 
different tests will be performed depending on the nature of the variables. The 
comparison between the values measured at the beginning and the values measured 
after 3 months in each group will be performed using the paired t test and will be 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
considered statistically significant when p<0.05. 
 
Inclusion criteria: 
 
ÿ Patients entitled to who attend the “Presidente” Regional Nutrition outpatient clinic 
Benito Juárez” diagnosed at most one year ago and who agree to participate 
in the study by signing the informed consent. 
ÿ Patients diagnosed with uncontrolled Diabetes Mellitus evidenced by biochemical 
markers, den- 
within a maximum of 1 month of validity, (fasting blood glucose greater than 140 
and glycosylated hemoglobin greater than 
(6.5%). 
ÿ Patients with regular attendance at the outpatient clinic for at least 3 consecutive 
months. 
 
 
 
 
Exclusion criteria: 
 
ÿ Patients diagnosed with chronic kidney disease undergoing renal function 
replacement therapy. 
ÿ Patients who already consume enough fiber and omega 3, as evidenced by the 
application of a reminder of 24 hours and a food frequency questionnaire. 
ÿ 
Pregnant 
or 
breastfeeding women. 
ÿ 
Patients 
in 
menopause. 
ÿ Patients with glucose disorders secondary to autoimmune 
diabetes, thyroid diseases or insulin-producing tumors. 
ÿ Patients with a medical history of poor drug adherence. 
ÿ Patients with adequate glycemic control evidenced by clinical laboratory 
tests for at least 2 months. ÿ Patients who cannot read or write. 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
ÿ Patients who do not have a means of contact for follow-up. 
Elimination criteria: 
 
ÿ Patients who do not agree to 
participate in the study. ÿ Data 
collection instrument with incomplete 
items. 
ÿ People who voluntarily withdraw from the 
study at any time. ÿ If the patient has 
surgery during the study. 
ÿ Patient who during the study begins to consume any type of 
supplement (vitamins, minerals, omega 3). 
ÿ Patient who stops consuming flaxseed during the study. 
 
 
8. Experience of the principal investigator and co-investigators in this type of research.  
 
(maximum) 
 
The principal investigator has participated in different research projects in the area, both as 
a collaborator and as principal investigator: 
 
 
-Collaborating researcher. Faculty of Nutrition. Universidad Veracruzana. “Evaluation of 
waist circumference in fifth period students of proposal 3 and 4 as a risk factor for 
developing metabolic syndrome”. Faculty of Nutrition. Xalapa, Universidad 
Veracruzana, Mexico. 2010. SATISFACTORILY COMPLETED 
 
 
-Collaborating researcher. Cooperation with the Coordination of the Master's Degree in 
Food and Nutritional Security. 
“Influence of maternal nutrition on the programming of fetal adipose tissue 
development”. Faculty of Nutrition. Universidad Veracruzana. 2011. SATISFACTORILY 
COMPLETED 
 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
- Collaborating Researcher. “Influence of physical activity on biochemical and 
vascular factors determining endothelial dysfunction in postmenopausal women”. 
Sant Joan de Reus University Hospital, Tarragona, Spain, 2012. SATISFACTORY 
COMPLETED 
 
-Collaborating researcher. INCOS Project (Community Health Intervention), “Effect of a 
community intervention in school children, considering nutritional and cognitive 
status”. Ccorca District, Cusco, Peru. 
NUTRISAM Research Group of the Rovira I Virgili University, Spain. 2013. Project Grant 
from the Rovira i Virgilli University, Spain. SATISFACTORILY COMPLETED 
 
-Principal investigator. PESA-T Project (Health Assessment Project) “Nutritional 
Transition State of the city of Cuzco, Peru”. NUTRISAM Research Group. Project Grant 
from the Rovira I Virgili University, Spain. March-September 2014. SATISFACTORILY 
COMPLETED 
 
-Principal investigator of the project “EMOTIONAL NUTRITIONAL STATUS IN FOOD 
SAFETY AND HEALTH 
 
THE OAXACAN POPULATION DURING CONFINEMENT DUE TO THE SARS-COV-2 
VI-RUS”, registered at the Nutrition Institute of the University of the Sierra Sur (UNSIS) 
with folio CEI-09A / 2020. In progress 
 
-Principal investigator of the project “NUTRITIONAL STATUS, FOOD CONSUMPTION 
AND INTAKE NUTRITIONAL IN CONFIRMED AND RECOVERED CASES BY SARS-
Cov-2 IN THE STATE OF OAXACA, MEXICO”, registered at the Nutrition Institute of the 
University of the Sierra Sur (UNSIS) with the folio INUT/NC/2021/01/270821. In progress 
-Co-technical manager of the Project “Molecular epidemiology of drug use and co-
morbidities in Mexican population, as well as its repercussions on the Mexican legal 
framework”, registered in the Institute of Nutrition from the University of the Sierra Sur. 
INUT/BMBCS/05/2020. In progress 
 
 
 
 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
 
9. Potential risks and benefits for participants and for society, as well as 
compensation for those involved  participants. 
According to the general health law on health research in its article 17, this is considered 
Low risk study because biochemical tests will be taken and this could cause the participant 
pain in the extraction area, and you may also experience some symptoms from taking 
flaxseed such as constipation, diarrhea, or gastrointestinal upset. 
The participant will not receive financial compensation, but the results of the study will be 
published and disseminated. results. Based on the results of the studies, participants may 
potentially receive the benefit of improved controlling your type 2 diabetes. 
 
 
10. 
Management of potential risks for participants. 
To minimize risks, researchers will be in daily contact with participants to warn them  
any damage to health and to know if any gastrointestinal reaction or even allergic reaction 
occurs, this in order to be able to tell you what to do or even stop the study if necessary. 
In case the discomfort persists, the responsibility of the research team will be guaranteed 
to provide immediate nutritional care to the participant (as established in articles 18 and 19 
of the Regulations) of the General Health Law on Health Research). 
The risk management process will be as follows: 
 
 
1. Identify 
risk 
The patient will be monitored in case of any health 
problems caused by flaxseed. 
2. 
A
nalyz
e 
The symptom will be analyzed. 
 
3. Prioritize 
risk 
4. Control the 
risk 
It will be verified that your health is not compromised. 
 
If the symptom is controllable, the treatment will continue and if it is 
not, the patient can withdraw. 
 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
of the study. If 
the 
patient 
presents any 
stress problems due to the administration 
tion is withdrawn from the study. 
 
 
11. 
Procedure by which consent to participate in the study will be obtained. 
• Participants who meet the inclusion criteria will be recruited in the 
nutrition outpatient clinic from the Regional Hospital of Oaxaca. 
• You will be provided with detailed information about the study and will be provided with 
written informed consent. legal participation document (ANNEX 1) 
• You will be given time to proceed with the reading of the document and you will have time in 
case the participant has doubts or questions about the study. 
 
 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
 
 
12. 
Management of confidentiality of information. 
 
 
Upon entering the study, each participant will be registered with a number by which 
they will be addressed throughout the study. All data will be treated anonymously. 
 
 
13. 
Conflicts of interest. 
 
There is no conflict of interest 
 
 
14. 
Bibliography  
Hasaniani N, Rahimlou M, Ramezani A, Mehdizadeh A and Alizadeh M. (2019) The 
Effect of Flaxseed Enriched Yogurt on the Glycemic Status and Cardiovascular Risk Factors 
in Patients with Type 2 Diabetes Mellitus: Randomized, Open-labeled, Controlled Study. 
Clinical Nutrition Research. 8(4):284- 295. https://doi.org/10.7762/cnr.2019.8.4.284 
 
Mohammadi M, Sohrabi Z, Barati R, Raeisi H and Mazloom Z. (2018). Flaxeed 
supplementation on glucose control and insulin sensitivity: a systematic review and meta-
analysis 
of 
25 
randomized, 
pa- 
cebo-control 
trials. 
76(2):125-139 
DOI: 
10.1093/nutrit/nux052. 
 
Nowak, W., & Jeziorek, M. (2023, January). The Role of Flaxseed in 
Improving Human Health. In Healthcare (Vol. 11, No. 3, p. 395). MDPI. 
 
Parikh, M., Maddaford, T.G., Austria, JA, Aliani, M., Netticadan, T., & 
Pierce, G.N. (2019). Dietary Flaxseed as a Strategy for Improving Human Health. 
Nutrients, 11(5), 1171. https://doi.org/10.3390/nu11051171 
 
Tharwat S, El-Megeid A, Salam R. Rashed L, El-Hamid S and Abdel-Shafy E. (2017). 
Effectiveness of Adding Flaxseed to Type 2 Diabetic Patient's Regimen. Endocrinology 
and metabolic syndrome. 6(3):1-5. https://www.longdom.org/open-access/effectiveness-of-
adding-flaxseed-to-type-2- diabetic-pa- tient8217s-regimen-24416.html 
 
Tinajero, MG, & Malik, VS (2021). An Update on the Epidemiology of Type 2 
Diabetes: A Global Perspective. Endocrinology and metabolism clinics of North 
America, 50(3), 337–355. https://doi.org/10.1016/j.ecl.2021.05.013 
 
 
Wu, Y., Ding, Y., Tanaka, Y., & Zhang, W. (2014). Risk factors contributing to type 
2 diabetes and recent advances in the treatment and prevention. International journal of 
medical sciences, 11(11), 1185–1200. https://doi.org/10.7150/ijms.10001 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
 
ANNEX 1 LEGAL INFORMED CONSENT 
 
 
Oaxaca de Juarez Oaxaca, to 
of
 
. 
 
 
INFORMED CONSENT 
 
 
Dear patient: 
A group of researchers attached to the Nutrition Institute of the University of the Sierra 
Sur, which is part of the SUNEO (State University System of Oaxaca) invites you to 
participate in the study “Effect of consumption of flaxseed as a treatment for adults 
with type 2 diabetes mellitus in Oaxaca de Juárez, Oaxaca.” 
 
We respectfully request that you read the following information carefully before agreeing to 
participate. 
 
 
Researchers 
Dr. Sabina López Toledo (Responsible) 
Maria Cruz Pineda De La Cruz 
General objective 
To assess the adjuvant effects of flaxseed consumption (14 g of flaxseed) on biochemical markers 
cos (glucose, glycosylated hemoglobin, total cholesterol, triglycerides, LDL cholesterol and HDL 
cholesterol) of patients Adults (30 to 70 years) with type 2 diabetes mellitus, who attend the 
Nutrition outpatient clinic at the Re-Hospital regional of Oaxaca. 
Specific objectives 
1. Describe the sociodemographic variables (age, sex, occupation, marital status) of adult 
patients (30 to 70 years) who suffer from type 2 diabetes, who attend the Nutrition outpatient 
clinic at the Regional Hospital from Oaxaca. 
2. Describe the clinical characteristics (time of evolution of the disease, type of 
treatment, control and comor- bilities), of adult patients (30 to 70 years) who suffer from 
type 2 diabetes, who attend the outpatient clinic of Nutrition at the Regional Hospital of 
Oaxaca. 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
3. Assess biochemical parameters (glucose, glycosylated hemoglobin, total cholesterol, 
triglycerides, cholesterol LDL and HDL cholesterol), of adult patients (30 to 70 years) who 
suffer from type 2 diabetes, who come to the consultation Nutrition external of the Regional 
Hospital of Oaxaca, 
 
4. Apply a nutritional intervention to two groups: Group A) Teaching the healthy 
eating plate and Group B) Teaching healthy eating dishes and indicating flaxseed 
consumption. 
5. Evaluate the effect of flaxseed consumption on biochemical markers (glucose, 
glycosylated hemoglobin, Total cholesterol, triglycerides, LDL cholesterol and HDL 
cholesterol of adult patients (30 to 70 years) suffering from type 2 diabetes, who attend the 
Nutrition outpatient clinic at the Regional Hospital in Oaxaca. 
6. Analyze the most effective possible combinations (pharmacological + non-pharmacological) for 
the treatment of adult patients (30 to 70 years) suffering from type 2 diabetes, who attend the 
Nutrition outpatient clinic at the Regional Hospital in Oaxaca. 
 
Justification 
 
Type 2 Diabetes Mellitus represents one of the most important health emergencies of this 
century. It is estimated that In 2019, there were already 463 million people with diabetes 
mellitus worldwide and this figure may increase to 578 million by 2030 and to 700 million 
by 2045. A state of hyperglycemia is associated with acute and chronic complications, in 
both cases affecting the cardiovascular system, mainly the blood vessels and 
consequently to the entire organism, but mainly to the eyes, kidneys, arteriovelocity 
systems. and peripheral nerves. Although it is known that insulin resistance is reversible 
and that diabetes is mellitus type 2 is controllable with a change towards a healthy 
lifestyle, the population ignores these recommendations and continue with their unhealthy 
habits. Thus, the number of patients continues to grow expo- essentially, which leads to 
an increase in economic expenditure on health. This is why They are looking for non-
pharmacological measures that favor the reduction of glycemia in patients with Diabetes 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
Mellitus where the consumption of functional foods is a good alternative for the treatment 
of this chronic disease. 
Flaxseed is a food that is characterized by its nutritional properties, highlighting its content in acid 
alpha linoleic acid, flax lignans, secoisolariciresinol diglucosides. The latter have 
antioxidant, hypolipidemic effect. miante and hypoglycemic, which makes it an excellent 
option as a functional treatment for diabetes type 2. 
Description of procedures 
Patients who sign the informed consent will be assigned a group according to the following: in the 
case 
If you have an even number in your file, you will be part of the control group (A), and if you have an 
odd number, you will be part from intervention group B. 
Group A. 
 
They will be given verbal instructions to continue with the treatment established by the treating 
physician, and they will be provided with nutritional guidance with the help of the healthy eating 
plate. 
Group B. 
 
They will be given verbal instructions to continue with the treatment established by the 
treating physician, they will be provided nutritional guidance with the help of the healthy 
eating plate and they will be provided with a pamphlet with the instructions written and 
photographed on how to consume flaxseed and its benefits. 
Phase 3. 
 
Administration of flaxseed 
 
Researchers will purchase, package, and provide flaxseed powder to members of group B. The 
flaxseed will be delivered in packets containing 16 g of ground flaxseed each, which will be given 
to patients for daily consumption (one 8 g spoonful of flaxseed in the morning snack and one 8 
g spoonful of flaxseed in the afternoon snack). 
(late). You will be provided with brochures with images explaining how to consume it and how the 
glass should look when finished. Various forms of consumption of the powder will also be provided 
to avoid getting bored with the taste and consistency of the powder. 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
 
Phase 4. 
 
Surveillance and monitoring. 
 
Daily contact will be maintained with participants via WhatsApp in order to remind them to take 
flaxseed. 
 
and also to find out if they have any adverse symptoms (abdominal distension, 
flatulence, gas, diarrhea, etc.), as well as to resolve doubts and ask if they should start 
taking some vitamins, minerals or medications. 
Both groups will be given a 24-hour recall and a food frequency questionnaire. 
 
every 15 days. The food consumption of both groups will be analyzed according to its 
nutritional content (energy, macro and micronutrients) and each nutrient will be used as 
a nutritional variable that can influence the control of the biochemical markers. 
 
Benefits 
 
You will not receive financial compensation, but the results of the study will be published and 
the results will be disseminated. According to the results of studies, you may potentially 
receive the benefit of improving the control of your Diabetes. 
type 2. 
 
 
Risks 
 
According to the general health law on health research in its article 17, this is considered 
 
This is a low-risk study because biochemical tests will be taken and this could cause pain in the 
 
area, you may also experience some symptoms from taking flaxseed such as constipation, diarrhea 
or 

Guillermo Rojas Mijangos s/n, Corner of University Ave., University City Neighborhood 
Miahuatlan de Porfirio Diaz, Oaxaca, Mexico CP 70800 
unsis.edu.mx 
 
 
gastrointestinal upset. To minimize risks, researchers will be in 
contact with you daily to tell you what to do or even stop the 
study if necessary. 
 
Voluntary participation/dropout 
Participation is completely voluntary, if for any reason you decide to leave the 
study, you may withdraw from research at any time you decide, without any 
repercussions of any kind. 
 
Expenses generated by research 
All expenses incurred will be covered by the researcher in charge. 
 
 
Confidentiality and disclosure of results 
Your privacy will be respected at all times; in all project processes you will be identified with 
a code based on a number and never by your name. The information you provide will be 
confidential. The results will be published/disclosed for the sole purpose of generating 
knowledge, always safeguarding your identification data. 
certification. 
 
Questions 
If you have any questions, comments or concerns regarding the project, please contact the 
Dr. Sabina López Toledo, project manager, at the email: sabina.ltoledo@gmail.com or at the 
phone number 5534142487 
who will clarify it for you immediately. 
 
 
Gratitude 
If you agree to participate in the study, we will give you a 
copy of this document. The research team appreciates your 
valuable participation. 
 
Consent 
 
I have been informed about my participation in this research. Therefore I give my consent to 
those in charge. 
of the project, so that they can ask the necessary questions, to which I will answer in a 
concrete manner and with the truth in at all times. 
 
_____________________________________________________________________________
Name and signature 
(or fingerprint) of 
participant 
Name, signature (or fingerprint) 
and address of witness 1 
Name, signature (or fingerprint) 
and address of witness 2