Clinical trial NCT02271776: GOS and Insulin Sensitivity
Official title: The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Insulin Sensitivity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2014-10-22
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: systemic insulin sensitivity
timeFrame: change from baseline at 12 week supplementation
Secondary outcomes:
measure: substrate oxidation and energy expenditure
timeFrame: change from baseline at 12 week supplementation
measure: plasma markers of substrate and energy metabolism
timeFrame: change from baseline at week 1 and at 12 week supplementation
measure: fecal and plasma SCFA concentrations
timeFrame: change from baseline at week 1 and at 12 week supplementation
measure: fecal microbiota composition
timeFrame: change from baseline at week 1 and at 12 week supplementation
measure: skeletal muscle and adipose tissue gen and protein expression
timeFrame: change from baseline at week 1 and at 12 week supplementation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Human Biology, Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Center
name: Ellen E Blaak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canfora EE, van der Beek CM, Hermes GDA, Goossens GH, Jocken JWE, Holst JJ, van Eijk HM, Venema K, Smidt H, Zoetendal EG, Dejong CHC, Lenaerts K, Blaak EE. Supplementation of Diet With Galacto-oligosaccharides Increases Bifidobacteria, but Not Insulin Sensitivity, in Obese Prediabetic Individuals. Gastroenterology. 2017 Jul;153(1):87-97.e3. doi: 10.1053/j.gastro.2017.03.051. Epub 2017 Apr 8.