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

Isafruit: Nutrigenomics in Overweight

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Apples; Dietary supplement: Apple pomace

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 1951
    • Department of Human Nutrition, Life, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Active Comparator: Apples	Dietary supplement: Apples; 550g of apples/day
Active Comparator: Apple pomace	Dietary supplement: Apple pomace; 22g apple pomace/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)	Measured at week 2
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)	Measured at week 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	Measured at week 2
Blood pressure	Measured at week 6
Anthropometry (weight, height, waist and hip circumference)	Measured at week 2
Anthropometry (weight, height, waist and hip circumference)	Measured at week 6
Inflammatory marker (hs-CRP)	Measured at week 2
Inflammatory marker (hs-CRP)	Measured at week 6
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)	Measured at week 2
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)	Measured at week 6
Urine analyses (metabolomics)	Measured at week 2
Urine analyses (metabolomics)	Measured at week 6
Serum insulin, IGF-1 and IGFBP-3 levels	Measured at week 2
Serum insulin, IGF-1 and IGFBP-3 levels	Measured at week 6
Gene expression in white blood cells and colon tissue	Measured at week 2
Gene expression in white blood cells and colon tissue	Measured at week 6
Enzyme activity in lysed erythrocytes (glutathione peroxidase)	Measured at week 2
Enzyme activity in lysed erythrocytes (glutathione peroxidase)	Measured at week 6

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Central Jutland Regional Hospital; Technical University of Denmark
• Investigators: Study Director: Susanne Bügel, PhD, Department of Human Nutrition, LIFE, University of Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Metabolomics; Prevention; Gene expression; Lipid metabolism; Apple; Antiinflammatory effect; Apple pomace
• Additional Relevant MeSH Terms: Body Weight; Cardiovascular Diseases; Overweight
• Other Study ID Numbers: M198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES