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

University of Copenhagen

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Apples; Dietary Supplement: Apple pomace

Study type: Interventional

Funder types: Other

Identifiers

NCT01141803

M198

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 3 patient groups

control

No Intervention group

Apples

Active Comparator group

Treatment:

Dietary Supplement: Apples

Apple pomace

Active Comparator group

Treatment:

Dietary Supplement: Apple pomace