Clinical trial NCT01141803: Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
Official title: Isafruit: Nutrigenomics in Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Apple
Apple pomace
Metabolomics
Gene expression
Lipid metabolism
Prevention
Antiinflammatory effect
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
name: Central Jutland Regional Hospital
First posted: 2010-06-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
timeFrame: Measured at week 2
measure: Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
timeFrame: Measured at week 6
Secondary outcomes:
measure: Blood pressure
timeFrame: Measured at week 2
measure: Blood pressure
timeFrame: Measured at week 6
measure: Anthropometry (weight, height, waist and hip circumference)
timeFrame: Measured at week 2
measure: Anthropometry (weight, height, waist and hip circumference)
timeFrame: Measured at week 6
measure: Inflammatory marker (hs-CRP)
timeFrame: Measured at week 2
measure: Inflammatory marker (hs-CRP)
timeFrame: Measured at week 6
measure: Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
timeFrame: Measured at week 2
measure: Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
timeFrame: Measured at week 6
measure: Urine analyses (metabolomics)
timeFrame: Measured at week 2
measure: Urine analyses (metabolomics)
timeFrame: Measured at week 6
measure: Serum insulin, IGF-1 and IGFBP-3 levels
timeFrame: Measured at week 2
measure: Serum insulin, IGF-1 and IGFBP-3 levels
timeFrame: Measured at week 6
measure: Gene expression in white blood cells and colon tissue
timeFrame: Measured at week 2
measure: Gene expression in white blood cells and colon tissue
timeFrame: Measured at week 6
measure: Enzyme activity in lysed erythrocytes (glutathione peroxidase)
timeFrame: Measured at week 2
measure: Enzyme activity in lysed erythrocytes (glutathione peroxidase)
timeFrame: Measured at week 6
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, LIFE, University of Copenhagen
Study officials:
affiliation: Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
name: Susanne Bügel, PhD
role: STUDY_DIRECTOR
References: