Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTApples550g of apples/day
DIETARY_SUPPLEMENTApple pomace22g 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.