GOS and Insulin Sensitivity

Obesity Clinical Trial

Official title:

The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271776
• Other study ID #: METC 143026
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: April 9, 2018
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypersensitivity
• Insulin Resistance
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Galactooligosaccharide
The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
• maltodextrin

Locations

Country	Name	City	State
Netherlands	Department of Human Biology, Maastricht University Medical Centre	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic insulin sensitivity		change from baseline at 12 week supplementation
Secondary	substrate oxidation and energy expenditure		change from baseline at 12 week supplementation
Secondary	plasma markers of substrate and energy metabolism		change from baseline at week 1 and at 12 week supplementation
Secondary	fecal and plasma SCFA concentrations		change from baseline at week 1 and at 12 week supplementation
Secondary	fecal microbiota composition		change from baseline at week 1 and at 12 week supplementation
Secondary	skeletal muscle and adipose tissue gen and protein expression		change from baseline at week 1 and at 12 week supplementation