Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT01141803
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2010-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
Isafruit: Nutrigenomics in Overweight
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: