Status:
COMPLETED
Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake
Lead Sponsor:
Nexira
Collaborating Sponsors:
Analyze & Realize
Conditions:
Healthy
Overweight
Eligibility:
All Genders
25-60 years
Phase:
NA
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 ...
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. Fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04515277
Start Date
June 28 2019
End Date
September 27 2019
Last Update
August 19 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Analyze & Realize
Berlin, Germany, 10369