Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
Isafruit: Nutrigenomics in Overweight
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cardiovascular-diseases
Started Jul 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJuly 20, 2016
July 1, 2016
1.4 years
June 8, 2010
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Measured at week 2
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Measured at week 6
Secondary Outcomes (16)
Blood pressure
Measured at week 2
Blood pressure
Measured at week 6
Anthropometry (weight, height, waist and hip circumference)
Measured at week 2
Anthropometry (weight, height, waist and hip circumference)
Measured at week 6
Inflammatory marker (hs-CRP)
Measured at week 2
- +11 more secondary outcomes
Study Arms (3)
control
NO INTERVENTIONApples
ACTIVE COMPARATORApple pomace
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy
- BMI over 30
- No daily medication
- Not strenuous exercise \> 10hours/week
- No blood donation 3 months before or during the study
You may not qualify if:
- Smoking
- Simultaneous participation in other research projects
- Use of any dietary supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Technical University of Denmarkcollaborator
- Central Jutland Regional Hospitalcollaborator
Study Sites (1)
Department of Human Nutrition, LIFE, University of Copenhagen
Frederiksberg, 1951, Denmark
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Susanne Bügel, PhD
Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 8, 2010
First Posted
June 11, 2010
Study Start
July 1, 2008
Primary Completion
December 1, 2009
Study Completion
October 1, 2010
Last Updated
July 20, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share