Trials / Completed
CompletedNCT01141803
Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
Isafruit: Nutrigenomics in Overweight
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- University of Copenhagen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers are randomly assigned one of three groups. They are instructed to follow a polyphenol and pectin restricted diet for six weeks. The last four weeks in this six week period, the restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the four weeks intervention period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Apples | 550g of apples/day |
| DIETARY_SUPPLEMENT | Apple pomace | 22g apple pomace/day |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2009-12-01
- Completion
- 2010-10-01
- First posted
- 2010-06-11
- Last updated
- 2016-07-20
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT01141803. Inclusion in this directory is not an endorsement.