Impact of diet-induced obesity on gut barrier integrity and metabolic diseases in healthy subjects
Not Applicable
- Conditions
- obesity-associated metabolic diseases in healthy subjects
- Registration Number
- DRKS00006211
- Lead Sponsor
- Bundesministerium für Bildung und Forschung Dienstsitz Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 25
Inclusion Criteria
BMI <= 25kg/m², stable weight during the last 3 months (+/-2kg); Non-smokers; Signed informed consent
Exclusion Criteria
Severe general diseases, e.g. cancer, COPD, severe heart disease (e.g. pacemaker), progressive renal failure, severe psychiatric or neurological diseases; Diabetes; Continuous treatment with oral anticoagulants or antithrombotics (except ASS 100); Malabsorption syndromes; Autonomous neuropathy; Poor compliance; lactose intolerance, sucrose intolerance, sucralose intolerance; Lack of written informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method gut permeability (using polyethylene glycol and sugar absorption test), changes in gut microbiota, inflammation marker in plasma and in peripheral immune cell sub-populations. <br>[Timeframe: baseline, after 7–day intervention period, 14 days after intervention is terminated]<br>
- Secondary Outcome Measures
Name Time Method insulin sensitivity, body composition, basal metabolic rate, blood parameters (fasting glucose, fasting insulin, liver function, kidney function, electrolyte, lipid profile, DNA, inflammation marker), blood pressure, pulse, eating behavior. <br>[Timeframe: baseline, after 7-day intervention period, 14 days after intervention is terminated]<br>