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OpenTrials
Completed

NCT Number: NCT01141803

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, LIFE, University of Copenhagen

Frederiksberg, 1951, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apples

Dietary Supplement

550g of apples/day

Apple pomace

Dietary Supplement

22g apple pomace/day

Primary outcomes

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

    Time frame: Measured at week 2

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

    Time frame: Measured at week 6

Secondary outcomes

  1. Blood pressure

    Time frame: Measured at week 2

  2. Blood pressure

    Time frame: Measured at week 6

  3. Anthropometry (weight, height, waist and hip circumference)

    Time frame: Measured at week 2

  4. Anthropometry (weight, height, waist and hip circumference)

    Time frame: Measured at week 6

  5. Inflammatory marker (hs-CRP)

    Time frame: Measured at week 2

  6. Inflammatory marker (hs-CRP)

    Time frame: Measured at week 6

  7. Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)

    Time frame: Measured at week 2

  8. Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)

    Time frame: Measured at week 6

  9. Urine analyses (metabolomics)

    Time frame: Measured at week 2

  10. Urine analyses (metabolomics)

    Time frame: Measured at week 6

  11. Serum insulin, IGF-1 and IGFBP-3 levels

    Time frame: Measured at week 2

  12. Serum insulin, IGF-1 and IGFBP-3 levels

    Time frame: Measured at week 6

  13. Gene expression in white blood cells and colon tissue

    Time frame: Measured at week 2

  14. Gene expression in white blood cells and colon tissue

    Time frame: Measured at week 6

  15. Enzyme activity in lysed erythrocytes (glutathione peroxidase)

    Time frame: Measured at week 2

  16. Enzyme activity in lysed erythrocytes (glutathione peroxidase)

    Time frame: Measured at week 6

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Central Jutland Regional Hospital
  • Technical University of Denmark

Registry information

Official study title

Isafruit: Nutrigenomics in Overweight

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jun 11, 2010
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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