Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight

Study Overview
=================
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.

Official Title
-----------------
Isafruit: Nutrigenomics in Overweight

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Apples
* Dietary Supplement: Apple pomace


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Active Comparator: Apples<br> | Dietary Supplement: Apples<br>* 550g of apples/day<br>|
| Active Comparator: Apple pomace<br> | Dietary Supplement: Apple pomace<br>* 22g apple pomace/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apple, Apple pomace, Metabolomics, Gene expression, Lipid metabolism, Prevention, Antiinflammatory effect