Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake

Study Overview
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Brief Summary
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Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin levels and food intake in normal-weight and overweight subjects during a 2-7 weeks intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be assessed.

Detailed Description
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Gum arabic is a heteropolysaccharide (molecular weight 350-850 kDa) harvested from Acacia seyal or Acacia senegal. It is highly soluble and broadly used in numerous solid and liquid food matrices. For the assessment of non-digestible carbohydrates as dietary fiber, it is eminent to demonstrate that its consumption is related to a specific beneficial physiological effect shown in an appropriate clinical study. The aim of the present trial was to expand the clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood glucose levels, post-prandial insulin levels and prospective ad libitum food intake, in normal-weight and overweight subjects. The present double-blind, randomized, controlled, three-way cross-over study was to evaluate the effect of gum acacia versus no treatment on post-prandial glucose (PPG) levels in normal-weight and overweight subjects during a 2-7 weeks intervention period. Additionally, post-prandial insulin (PPI) levels, prospective ad libitum food intake, as well as the safety and tolerability of gum acacia were assessed.

Official Title
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Double-blind, Randomized, Controlled, Three-way Cross-over Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose and Insulin Levels and Food Intake

Conditions
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Healthy, Overweight

Intervention / Treatment
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* Dietary Supplement: 40 g Gum acacia (FibregumTM)
* Dietary Supplement: 20 g Gum acacia (FibregumTM)
* Dietary Supplement: 0 g Gum acacia (FibregumTM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women from 25 to 60 years old Body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2 Generally in good health Normal fasting blood glucose (FBG) 3.9 to <5.6 mmol/L (70 to <100 mg/dL) and HbA1c of 4 to <5.7 % Regularly consuming 3 main meals/day, with breakfast and lunch as dominant meals Familiar with components of the study meals, no disliking and/or extreme preferences for any of the items Readiness to comply with study procedures, in particular: adhere to the defined restrictions prior to / procedures on the test days maintain the habitual level of physical activity and sleep habits during the study fill out the study diary Stable body weight in the last 3 months prior to V1 (≤3% self-reported change) Stable concomitant medications (if any) for at least last 3 months prior to V1 Women of childbearing potential: commitment to use contraception methods negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 Readiness not to participate in another clinical study during this study Exclusion Criteria: Known allergy or hypersensitivity to the components of the investigational product / study meals History and/or presence of clinically significant self-reported disorder as per investigator's judgement: untreated or non-stabilized thyroid gland disorder untreated or non-stabilized hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) and/or GI surgery diabetes mellitus sleep disorder acute or chronic psychiatric disorder any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject Subjects with difficult vein access or sensitive to blood draws Nighttime eating/snacking (after 10 pm) Excessive consumption of artificial sweeteners (e.g. in beverages) History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement Use of treatment/supplementation in the last 2 months prior to V1 and during the study, as per investigator's judgment, that could influence gastrointestinal functions, body weight, blood glucose levels or otherwise interfere with study conduct / evaluation Deviation of safety laboratory parameter(s) at V1 (except for Hb and HbA1c) that is: clinically significant or >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome) Diet/weight loss programs within the last 3 months prior to V1 and during the study Recent blood donation within the last 1 month prior to study Smoking within the last 6 months prior to V1 and during the study Vegetarian, vegan or other restrictive diet Night shift work History or current abuse of alcohol, drug and/or medication Women of child-bearing potential: pregnancy or nursing Inability to comply with study procedures Participation in another study during the last 30 days prior to V1 Any other reason deemed suitable for exclusion, per investigator's judgment

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blind, randomized, controlled, three-way cross-over design, monocentric nutritional study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40 g (D1)<br>40 g gum acacia powder (D1). Treatment type is applied with the standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). | Dietary Supplement: 40 g Gum acacia (FibregumTM)<br>* Applied in 300 mL of orange juice with breakfast (single use at visit)<br>* Other names: D1;|
| Active Comparator: 20 g (D2)<br>20 g gum acacia powder (D2). Treatment type is applied with the standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). | Dietary Supplement: 20 g Gum acacia (FibregumTM)<br>* Applied in 300 mL of orange juice with breakfast (single use at visit)<br>* Other names: D2;|
| Other: No treatment (NT)<br>0 g gum acacia powder. Standardized breakfast (in 300 mL orange juice) on the test days (V2, V3 or V4). | Dietary Supplement: 0 g Gum acacia (FibregumTM)<br>* 300 mL of orange juice with breakfast (single use at visit)<br>* Other names: no treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group | Venous blood samples were drawn for the determination of glucose values, with sampling times at -15 min and immediately prior to the intake of the standardized breakfast (time 0) as well as 15, 30, 45, 60, 90 and 120 min after the 0 min blood draw. | 2 -7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in blood glucose incremental AUC 0-120 min between D2 verum group and no treatment group | Venous blood samples were drawn for the determination of glucose values, with sampling times at -15 min and immediately prior to the intake of the standardized breakfast (time 0) as well as 15, 30, 45, 60, 90 and 120 min after the 0 min blood draw. | 2 -7 weeks | 
| Food (energy) intake at ad libitum lunch, in comparison between each verum group vs no treatment group | Food was weighed before the subject consumed the meal and afterwards and the energy content of the food consumed was determined. | 2 -7 weeks | 
| Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min | Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows: Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - maximal/minimal VAS values | Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows: Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min | Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows: Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Individual appetite sensation items (VAS for satiety, hunger, fullness, prospective consumption, desire to eat), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min | Visual analogue scales (VAS) for satiety, hunger, fullness, prospective consumption, desire to eat will be reported as follows: Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. VAS, 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Fullness: How full are you? (Not at all <-> Extremely / As full as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - VAS values at all time points 0, 15, 30, 45, 60, 90, 120, 180, 210, 240 min | Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4). Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - maximal/minimal VAS values | Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4). Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min | Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4). Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| Composite score ([desire to eat + hunger + (100-fullness) + prospective consumption]/4), in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180, 0-210, 0-240 min | Composite score is calculated as follows:([desire to eat + hunger + (100 - satiety) + estimated consumption]/4). Subjects had to record their appetite sensation before and after consumption of the standardised breakfast provided on site. Visual analogue scales (VAS), 100-mm in length, were used to assess the following items: Hunger: How hungry are you? (Not at all <-> Extremely / As hungry as I have ever felt) Satiety: How satiated are you? (Not at all <-> Extremely) Desire to eat (appetite): How strong is your desire to eat? (Very weak / Extremely low <-> Very strong / Extremely high) Prospective consumption (Quantity): How much do you think you could (or would want to) eat right now? (Nothing at all <-> A very large amount) | 2 -7 weeks | 
| 24 hour energy intake on test days: breakfast+ad libitum lunch+diary records, in comparison between each verum group vs no treatment group | After each of the site visits on test days, food and beverage intake during the time period until 24 hours after start of site visit had to be documented by the subjects in the study diary and the energy. | 2 -7 weeks | 
| PPG, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min | Venous blood samples were drawn for the determination of glucose values | 2 -7 weeks | 
| PPG, in comparison between each verum group vs no treatment group - maximal concentration | Venous blood samples were drawn for the determination of glucose values | 2 -7 weeks | 
| PPG, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min | Venous blood samples were drawn for the determination of glucose values | 2 -7 weeks | 
| PPG, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-180 min | Venous blood samples were drawn for the determination of glucose values | 2 -7 weeks | 
| PPI, in comparison between each verum group vs no treatment group - concentration at all time points 0, 15, 30, 45, 60, 90, 120, 180 min | Venous blood samples were drawn for the determination of insulin values | 2 -7 weeks | 
| PPI, in comparison between each verum group vs no treatment group - maximal concentration | Venous blood samples were drawn for the determination of insulin values | 2 -7 weeks | 
| PPI, in comparison between each verum group vs no treatment group - total AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min | Venous blood samples were drawn for the determination of insulin values | 2 -7 weeks | 
| PPI, in comparison between each verum group vs no treatment group - incremental AUC 0-15, 0-30, 0-45, 0-60, 0-90, 0-120, 0-180 min | Venous blood samples were drawn for the determination of insulin values | 2 -7 weeks | 
| Global evaluation (by 4-point scale) of benefit by subject and the investigator, in comparison between each verum group vs no treatment group | The investigators had to evaluate the benefit of the treatment type (global scaled evaluation with very good, good, moderate and poor). | 2 -7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gum acacia, post-prandial glucose (PPG), post-prandial insulin (PPI), blood glucose incremental, appetite sensation, E 414, food additive, FibregumTM, appetite, dietary fibre