Back to resultsGOS and Insulin Sensitivity
Primary Purpose
Obesity, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Galactooligosaccharide
maltodextrin
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Insulin Sensitivity
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
Sites / Locations
- Department of Human Biology, Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Galactooligosaccharide
maltodextrin
Arm Description
5g 3x per day for 12 weeks
3x per day for 12 weeks (isocaloric to intervention)
Outcomes
Primary Outcome Measures
systemic insulin sensitivity
Secondary Outcome Measures
substrate oxidation and energy expenditure
plasma markers of substrate and energy metabolism
fecal and plasma SCFA concentrations
fecal microbiota composition
skeletal muscle and adipose tissue gen and protein expression
Full Information
NCT ID
NCT02271776
First Posted
October 20, 2014
Last Updated
April 9, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT02271776
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Top Institute Food and Nutrition
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes Mellitus
Keywords
Insulin Sensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galactooligosaccharide
Arm Type
Active Comparator
Arm Description
5g 3x per day for 12 weeks
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Arm Description
3x per day for 12 weeks (isocaloric to intervention)
Intervention Type
Dietary Supplement
Intervention Name(s)
Galactooligosaccharide
Intervention Description
The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
maltodextrin
Primary Outcome Measure Information:
Title
systemic insulin sensitivity
Time Frame
change from baseline at 12 week supplementation
Secondary Outcome Measure Information:
Title
substrate oxidation and energy expenditure
Time Frame
change from baseline at 12 week supplementation
Title
plasma markers of substrate and energy metabolism
Time Frame
change from baseline at week 1 and at 12 week supplementation
Title
fecal and plasma SCFA concentrations
Time Frame
change from baseline at week 1 and at 12 week supplementation
Title
fecal microbiota composition
Time Frame
change from baseline at week 1 and at 12 week supplementation
Title
skeletal muscle and adipose tissue gen and protein expression
Time Frame
change from baseline at week 1 and at 12 week supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen E Blaak
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Biology, Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6200MD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
28396144
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.
Results Reference
derived
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GOS and Insulin Sensitivity
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