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

Cardiovascular Diseases Clinical Trial

Official title:

Isafruit: Nutrigenomics in Overweight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141803
• Other study ID #: M198
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: July 19, 2016
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: July 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Overweight

Intervention

Dietary Supplement:
• Apples
550g of apples/day
• Apple pomace
22g apple pomace/day

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, LIFE, University of Copenhagen	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Central Jutland Regional Hospital, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)		Measured at week 2	No
Primary	Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)		Measured at week 6	No
Secondary	Blood pressure		Measured at week 2	No
Secondary	Blood pressure		Measured at week 6	No
Secondary	Anthropometry (weight, height, waist and hip circumference)		Measured at week 2	No
Secondary	Anthropometry (weight, height, waist and hip circumference)		Measured at week 6	No
Secondary	Inflammatory marker (hs-CRP)		Measured at week 2	No
Secondary	Inflammatory marker (hs-CRP)		Measured at week 6	No
Secondary	Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)		Measured at week 2	No
Secondary	Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)		Measured at week 6	No
Secondary	Urine analyses (metabolomics)		Measured at week 2	No
Secondary	Urine analyses (metabolomics)		Measured at week 6	No
Secondary	Serum insulin, IGF-1 and IGFBP-3 levels		Measured at week 2	No
Secondary	Serum insulin, IGF-1 and IGFBP-3 levels		Measured at week 6	No
Secondary	Gene expression in white blood cells and colon tissue		Measured at week 2	No
Secondary	Gene expression in white blood cells and colon tissue		Measured at week 6	No
Secondary	Enzyme activity in lysed erythrocytes (glutathione peroxidase)		Measured at week 2	No
Secondary	Enzyme activity in lysed erythrocytes (glutathione peroxidase)		Measured at week 6	No