Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Technical University of Denmark
Viborg Hospital
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01141803
First received: June 8, 2010
Last updated: June 10, 2010
Last verified: December 2009

June 8, 2010
June 10, 2010
July 2008
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01141803 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Dietary Supplement: Apples
    550g of apples/day
  • Dietary Supplement: Apple pomace
    22g apple pomace/day
  • No Intervention: control
  • Active Comparator: Apples
    Intervention: Dietary Supplement: Apples
  • Active Comparator: Apple pomace
    Intervention: Dietary Supplement: Apple pomace
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
October 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01141803
M198
No
Susanne Bügel associate professor, IHE LIFE KU
University of Copenhagen
  • Technical University of Denmark
  • Viborg Hospital
Study Director: Susanne Bügel, PhD Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
University of Copenhagen
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP