Trials / Completed
CompletedNCT02215343
Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers
Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers. Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Wheat bran extract | Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R\&D Centre Europe). |
| DIETARY_SUPPLEMENT | Fish oil | Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark). |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2014-08-13
- Last updated
- 2020-05-20
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT02215343. Inclusion in this directory is not an endorsement.