Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Technical University of Denmark
Central Jutland Regional Hospital
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01141803
First received: June 8, 2010
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Cardiovascular Diseases
Dietary Supplement: Apples
Dietary Supplement: Apple pomace

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Isafruit: Nutrigenomics in Overweight

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Anthropometry (weight, height, waist and hip circumference) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Anthropometry (weight, height, waist and hip circumference) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Inflammatory marker (hs-CRP) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Inflammatory marker (hs-CRP) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Urine analyses (metabolomics) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Urine analyses (metabolomics) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Serum insulin, IGF-1 and IGFBP-3 levels [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Serum insulin, IGF-1 and IGFBP-3 levels [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Gene expression in white blood cells and colon tissue [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Gene expression in white blood cells and colon tissue [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]
  • Enzyme activity in lysed erythrocytes (glutathione peroxidase) [ Time Frame: Measured at week 2 ] [ Designated as safety issue: No ]
  • Enzyme activity in lysed erythrocytes (glutathione peroxidase) [ Time Frame: Measured at week 6 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: July 2008
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141803

Locations
Denmark
Department of Human Nutrition, LIFE, University of Copenhagen
Frederiksberg, Denmark, 1951
Sponsors and Collaborators
University of Copenhagen
Technical University of Denmark
Central Jutland Regional Hospital
Investigators
Study Director: Susanne Bügel, PhD Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
  More Information

Responsible Party: Arne Astrup, professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01141803     History of Changes
Other Study ID Numbers: M198 
Study First Received: June 8, 2010
Last Updated: July 19, 2016
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by University of Copenhagen:
Apple
Apple pomace
Metabolomics
Gene expression
Lipid metabolism
Prevention
Antiinflammatory effect

Additional relevant MeSH terms:
Cardiovascular Diseases
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016