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

Primary Purpose

Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Apples
Apple pomace
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Apple, Apple pomace, Metabolomics, Gene expression, Lipid metabolism, Prevention, Antiinflammatory effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Human Nutrition, LIFE, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

control

Apples

Apple pomace

Arm Description

Outcomes

Primary Outcome Measures

Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2010
Last Updated
July 19, 2016
Sponsor
University of Copenhagen
Collaborators
Technical University of Denmark, Central Jutland Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01141803
Brief Title
Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
Official Title
Isafruit: Nutrigenomics in Overweight
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Technical University of Denmark, Central Jutland Regional Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Apple, Apple pomace, Metabolomics, Gene expression, Lipid metabolism, Prevention, Antiinflammatory effect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Title
Apples
Arm Type
Active Comparator
Arm Title
Apple pomace
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Apples
Intervention Description
550g of apples/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Apple pomace
Intervention Description
22g apple pomace/day
Primary Outcome Measure Information:
Title
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Time Frame
Measured at week 2
Title
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Time Frame
Measured at week 6
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
Measured at week 2
Title
Blood pressure
Time Frame
Measured at week 6
Title
Anthropometry (weight, height, waist and hip circumference)
Time Frame
Measured at week 2
Title
Anthropometry (weight, height, waist and hip circumference)
Time Frame
Measured at week 6
Title
Inflammatory marker (hs-CRP)
Time Frame
Measured at week 2
Title
Inflammatory marker (hs-CRP)
Time Frame
Measured at week 6
Title
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Time Frame
Measured at week 2
Title
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Time Frame
Measured at week 6
Title
Urine analyses (metabolomics)
Time Frame
Measured at week 2
Title
Urine analyses (metabolomics)
Time Frame
Measured at week 6
Title
Serum insulin, IGF-1 and IGFBP-3 levels
Time Frame
Measured at week 2
Title
Serum insulin, IGF-1 and IGFBP-3 levels
Time Frame
Measured at week 6
Title
Gene expression in white blood cells and colon tissue
Time Frame
Measured at week 2
Title
Gene expression in white blood cells and colon tissue
Time Frame
Measured at week 6
Title
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Time Frame
Measured at week 2
Title
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Time Frame
Measured at week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Bügel, PhD
Organizational Affiliation
Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Department of Human Nutrition, LIFE, University of Copenhagen
City
Frederiksberg
ZIP/Postal Code
1951
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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