NCT02271776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 10, 2018

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 20, 2014

Last Update Submit

April 9, 2018

Conditions

ObesityType 2 Diabetes Mellitus

Keywords

Insulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • systemic insulin sensitivity

    change from baseline at 12 week supplementation

Secondary Outcomes (5)

  • 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

Study Arms (2)

Galactooligosaccharide

ACTIVE COMPARATOR

5g 3x per day for 12 weeks

Dietary Supplement: Galactooligosaccharide

maltodextrin

PLACEBO COMPARATOR

3x per day for 12 weeks (isocaloric to intervention)

Dietary Supplement: maltodextrin

Interventions

GalactooligosaccharideDIETARY_SUPPLEMENT

The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks

Galactooligosaccharide
maltodextrinDIETARY_SUPPLEMENT
maltodextrin

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Biology, Maastricht University Medical Centre

Maastricht, 6200MD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28396144DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin Resistance

Interventions

4'-galactooligosaccharidemaltodextrin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Ellen E Blaak

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 10, 2018

Record last verified: 2015-10

Locations

NL(1)