---
title: GOS and Insulin Sensitivity
nct_id: NCT02271776
overall_status: COMPLETED
phase: NA
sponsor: Maastricht University Medical Center
study_type: INTERVENTIONAL
primary_condition: Obesity
countries: Netherlands
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02271776.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02271776"
ct_last_update_post_date: 2018-04-10
last_seen_at: "2026-05-12T06:01:46.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02271776](https://clinicaltrials.gov/study/NCT02271776)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 46
- **Lead Sponsor:** Maastricht University Medical Center
- **Collaborators:** Top Institute Food and Nutrition
- **Conditions:** Obesity, Type 2 Diabetes Mellitus
- **Start Date:** 2014-10
- **Completion Date:** 2015-10
- **CT.gov Last Update:** 2018-04-10

## 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

- **Minimum age:** 45 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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

- **Galactooligosaccharide** (ACTIVE_COMPARATOR) — 5g 3x per day for 12 weeks
- **maltodextrin** (PLACEBO_COMPARATOR) — 3x per day for 12 weeks (isocaloric to intervention)

## Interventions

- **Galactooligosaccharide** (DIETARY_SUPPLEMENT) — The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
- **maltodextrin** (DIETARY_SUPPLEMENT)

## Primary Outcomes

- **systemic insulin sensitivity** _(time frame: change from baseline at 12 week supplementation)_

## Secondary Outcomes

- **substrate oxidation and energy expenditure** _(time frame: change from baseline at 12 week supplementation)_
- **plasma markers of substrate and energy metabolism** _(time frame: change from baseline at week 1 and at 12 week supplementation)_
- **fecal and plasma SCFA concentrations** _(time frame: change from baseline at week 1 and at 12 week supplementation)_
- **fecal microbiota composition** _(time frame: change from baseline at week 1 and at 12 week supplementation)_
- **skeletal muscle and adipose tissue gen and protein expression** _(time frame: change from baseline at week 1 and at 12 week supplementation)_

## Locations (1)

- Department of Human Biology, Maastricht University Medical Centre, Maastricht, Netherlands

## Recent Field Changes (last 30 days)

- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.department of human biology, maastricht university medical centre|maastricht||netherlands` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02271776.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02271776*  
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