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| Name | Class |
|---|---|
| Technical University of Denmark | OTHER |
| Central Jutland Regional Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | ||
| Apples | Active Comparator |
| |
| Apple pomace | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apples | Dietary Supplement | 550g of apples/day |
| |
| Apple pomace |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Measured at week 2 | |
| Blood pressure | Measured at week 6 | |
| Anthropometry (weight, height, waist and hip circumference) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Bügel, PhD | Department of Human Nutrition, LIFE, University of Copenhagen, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, LIFE, University of Copenhagen | Frederiksberg | 1951 | Denmark |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Dietary Supplement |
22g apple pomace/day |
|
| Measured at week 2 |
| Anthropometry (weight, height, waist and hip circumference) | Measured at week 6 |
| Inflammatory marker (hs-CRP) | Measured at week 2 |
| Inflammatory marker (hs-CRP) | Measured at week 6 |
| Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids) | Measured at week 2 |
| Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids) | Measured at week 6 |
| Urine analyses (metabolomics) | Measured at week 2 |
| Urine analyses (metabolomics) | Measured at week 6 |
| Serum insulin, IGF-1 and IGFBP-3 levels | Measured at week 2 |
| Serum insulin, IGF-1 and IGFBP-3 levels | Measured at week 6 |
| Gene expression in white blood cells and colon tissue | Measured at week 2 |
| Gene expression in white blood cells and colon tissue | Measured at week 6 |
| Enzyme activity in lysed erythrocytes (glutathione peroxidase) | Measured at week 2 |
| Enzyme activity in lysed erythrocytes (glutathione peroxidase) | Measured at week 6 |