Cardiovascular Diseases
Conditions
Keywords
Apple, Apple pomace, Metabolomics, Gene expression, Lipid metabolism, Prevention, Antiinflammatory effect
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.
Interventions
DIETARY_SUPPLEMENTApples
550g of apples/day
DIETARY_SUPPLEMENTApple pomace
22g apple pomace/day
Sponsors
Technical University of Denmark
Central Jutland Regional Hospital
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol) | Measured at week 2 |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometry (weight, height, waist and hip circumference) | Measured at week 2 |
| Inflammatory marker (hs-CRP) | Measured at week 2 |
| Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids) | Measured at week 2 |
| Blood pressure | Measured at week 2 |
| Serum insulin, IGF-1 and IGFBP-3 levels | Measured at week 2 |
| Gene expression in white blood cells and colon tissue | Measured at week 2 |
| Enzyme activity in lysed erythrocytes (glutathione peroxidase) | Measured at week 2 |
| Urine analyses (metabolomics) | Measured at week 2 |
Countries
Denmark
Outcome results
None listed