NCT02271776CompletedNot Applicable
The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis
Maastricht University Medical Center1 site in 1 country46 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- systemic insulin sensitivity
Study Overview
Brief Summary
Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years will be included in the study.
- •In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
Exclusion Criteria
- •diabetes mellitus
- •gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
- •lactose intolerance and other digestive disorders
- •cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
- •disease with a life expectancy shorter than 5 years
- •abuse of products (alcohol consumption > 15 units/week, or any drugs)
- •excessive nicotine use defined as >20 cigarettes per day
Arms & Interventions
Galactooligosaccharide
Active Comparator
5g 3x per day for 12 weeks
Intervention: Galactooligosaccharide (Dietary Supplement)
maltodextrin
Placebo Comparator
3x per day for 12 weeks (isocaloric to intervention)
Intervention: maltodextrin (Dietary Supplement)
Outcomes
Primary Outcomes
systemic insulin sensitivity
Time Frame: change from baseline at 12 week supplementation
Secondary Outcomes
- substrate oxidation and energy expenditure(change from baseline at 12 week supplementation)
- plasma markers of substrate and energy metabolism(change from baseline at week 1 and at 12 week supplementation)
- fecal and plasma SCFA concentrations(change from baseline at week 1 and at 12 week supplementation)
- fecal microbiota composition(change from baseline at week 1 and at 12 week supplementation)
- skeletal muscle and adipose tissue gen and protein expression(change from baseline at week 1 and at 12 week supplementation)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Galactooligosaccharide (GOS) Supplementation and Calcium Absorption in GirlsOsteoporosisNCT01263847Purdue University31
Recruiting
Not Applicable
The effect of galacto-oligosaccharides (GOS) versus a placebo on defecation parameters and microbiota in healthy children with hard or lumpy stoolsdifficulty with defecationhard or lumpy stools10017977NL-OMON54825Wageningen Universiteit196
Completed
Not Applicable
The effects of galactooligosaccharide (GOS) on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasisoverweight10018424insulin resistanceNL-OMON40698niversiteit Maastricht46
Recruiting
Not Applicable
The effect of galacto-oligosaccharides (GOS) or chicory fructo-oligosaccharides (FOS) versus a placebo on bowel habits in children with functional constipation.constipationfunctional constipation10017977NL-OMON54813Wageningen Universiteit198
Completed
Not Applicable
Effect of Galacto-Oligosaccharides supplementation on amoxicillin-treated gut microbiota from healthy adults : a proof of principal studymicrobiota activityMicrobiota composition10017966NL-OMON39559Wageningen Universiteit10