Trials / Completed
CompletedNCT02786160
Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
The Effects of Human Milk Oligosaccharides (HMO) on the Faecal Microbiota and on Host Metabolism in Obese Children: A Parallel, Double-blind, Randomized, Placebo-controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Glycom A/S · Industry
- Sex
- All
- Age
- 5 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group). The primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | HMO | |
| DIETARY_SUPPLEMENT | Dextropur |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2016-05-30
- Last updated
- 2018-12-13
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02786160. Inclusion in this directory is not an endorsement.