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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.
Full 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.
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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:
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:
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:
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:
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
Primary purpose
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36 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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