An interventional study of Apples and Apple pomace in Cardiovascular Diseases, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-20.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 37 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Apples
Dietary Supplement: Apple pomace
550g of apples/day
22g apple pomace/day
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Time frame: Measured at week 2
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Time frame: Measured at week 6
Blood pressure
Time frame: Measured at week 2
Blood pressure
Time frame: Measured at week 6
Anthropometry (weight, height, waist and hip circumference)
Time frame: Measured at week 2
Anthropometry (weight, height, waist and hip circumference)
Time frame: Measured at week 6
Inflammatory marker (hs-CRP)
Time frame: Measured at week 2
Inflammatory marker (hs-CRP)
Time frame: Measured at week 6
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Time frame: Measured at week 2
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Time frame: Measured at week 6
Urine analyses (metabolomics)
Time frame: Measured at week 2
Urine analyses (metabolomics)
Time frame: Measured at week 6
Serum insulin, IGF-1 and IGFBP-3 levels
Time frame: Measured at week 2
Serum insulin, IGF-1 and IGFBP-3 levels
Time frame: Measured at week 6
Gene expression in white blood cells and colon tissue
Time frame: Measured at week 2
Gene expression in white blood cells and colon tissue
Time frame: Measured at week 6
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Time frame: Measured at week 2
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Time frame: Measured at week 6
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Copenhagen