Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Apple pomace; Dietary Supplement: Apples

• Registration Number: NCT01141803
• Lead Sponsor: University of Copenhagen

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

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-12
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Study Completion: 2010-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Healthy
• BMI over 30
• No daily medication
• Not strenuous exercise > 10hours/week
• No blood donation 3 months before or during the study

Exclusion Criteria

• Smoking
• Simultaneous participation in other research projects
• Use of any dietary supplements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apple pomace	Apple pomace	-
Apples	Apples	-

Primary Outcome Measures

Name	Time	Method
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)	Measured at week 6

Secondary Outcome Measures

Name	Time	Method
Urine analyses (metabolomics)	Measured at week 6
Serum insulin, IGF-1 and IGFBP-3 levels	Measured at week 6
Inflammatory marker (hs-CRP)	Measured at week 6
Gene expression in white blood cells and colon tissue	Measured at week 6
Enzyme activity in lysed erythrocytes (glutathione peroxidase)	Measured at week 6
Blood pressure	Measured at week 6
Anthropometry (weight, height, waist and hip circumference)	Measured at week 6
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)	Measured at week 6

Trial Locations

Locations (1)

Department of Human Nutrition, LIFE, University of Copenhagen; 🇩🇰 Frederiksberg, Denmark