Clinical trial NCT04515277: Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Overweight
Keywords: gum acacia
post-prandial glucose (PPG)
post-prandial insulin (PPI)
blood glucose incremental
appetite sensation
E 414
food additive
FibregumTM
appetite
dietary fibre
Lead sponsor: Nexira
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2020-08-17
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomized, controlled, three-way cross-over design, monocentric nutritional study
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Men and women from 25 to 60 years old
2. Body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2
3. Generally in good health
4. Normal fasting blood glucose (FBG) 3.9 to \<5.6 mmol/L (70 to \<100 mg/dL) and HbA1c of 4 to \<5.7 %
5. Regularly consuming 3 main meals/day, with breakfast and lunch as dominant meals
6. Familiar with components of the study meals, no disliking and/or extreme preferences for any of the items
7. 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
8. Stable body weight in the last 3 months prior to V1 (≤3% self-reported change)
9. Stable concomitant medications (if any) for at least last 3 months prior to V1
10. Women of childbearing potential:

    * commitment to use contraception methods
    * negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
11. Readiness not to participate in another clinical study during this study

Exclusion Criteria:

1. Known allergy or hypersensitivity to the components of the investigational product / study meals
2. 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
3. Subjects with difficult vein access or sensitive to blood draws
4. Nighttime eating/snacking (after 10 pm)
5. Excessive consumption of artificial sweeteners (e.g. in beverages)
6. History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
7. 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
8. 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)
9. Diet/weight loss programs within the last 3 months prior to V1 and during the study
10. Recent blood donation within the last 1 month prior to study
11. Smoking within the last 6 months prior to V1 and during the study
12. Vegetarian, vegan or other restrictive diet
13. Night shift work
14. History or current abuse of alcohol, drug and/or medication
15. Women of child-bearing potential: pregnancy or nursing
16. Inability to comply with study procedures
17. Participation in another study during the last 30 days prior to V1
18. Any other reason deemed suitable for exclusion, per investigator's judgment

Primary outcomes:
measure: Difference in blood glucose incremental AUC 0-120 min between D1 verum group and no treatment group
timeFrame: 2 -7 weeks
Secondary outcomes:
measure: Difference in blood glucose incremental AUC 0-120 min between D2 verum group and no treatment group
timeFrame: 2 -7 weeks
measure: Food (energy) intake at ad libitum lunch, in comparison between each verum group vs no treatment group
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 24 hour energy intake on test days: breakfast+ad libitum lunch+diary records, in comparison between each verum group vs no treatment group
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: PPG, in comparison between each verum group vs no treatment group - maximal concentration
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: PPI, in comparison between each verum group vs no treatment group - maximal concentration
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: 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
timeFrame: 2 -7 weeks
measure: Global evaluation (by 4-point scale) of benefit by subject and the investigator, in comparison between each verum group vs no treatment group
timeFrame: 2 -7 weeks
Other outcomes:
measure: Gastrointestinal tolerability evaluation (by 4-point scale), in comparison between each verum group and no treatment group
timeFrame: 2 -7 weeks
measure: Blood pressure (systolic and diastolic), in comparison between each verum group and no treatment group
timeFrame: 2 -7 weeks
measure: Pulse rate, in comparison between each verum group and no treatment group
timeFrame: 2 -7 weeks
measure: Global evaluation (by 4-point scale) of tolerability by subject and investigator at study end, in comparison between each verum group and no treatment group
timeFrame: 2 -7 weeks
measure: Assessment of adverse events throughout the study
timeFrame: 2 -7 weeks
measure: Body weight, in comparison between each verum group and no treatment group
timeFrame: 2 -7 weeks
measure: Changes in dietary habits, physical activities and sleep habits by questioning, in comparison between each verum group and no treatment group
timeFrame: 2 -7 weeks
Locations:
city: Berlin
country: Germany
facility: Analyze & Realize
Study officials:
References: