obesity-associated metabolic diseases in healthy subjects
Conditions
Interventions
Group 1: 24 healthy male subjects (BMI less or equal 25 kg/m²) receive an individually adapted diet for seven days with an excess of 1000kcal/day in addition to their individual total energy requireme
Sponsors
Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: BMI <= 25kg/m², stable weight during the last 3 months (+/-2kg); Non-smokers; Signed informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gut permeability (using polyethylene glycol and sugar absorption test), changes in gut microbiota, inflammation marker in plasma and in peripheral immune cell sub-populations. [Timeframe: baseline, after 7–day intervention period, 14 days after intervention is terminated] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. [Timeframe: baseline, after 7-day intervention period, 14 days after intervention is terminated] | — |
Countries
Germany
Contacts
Public ContactBeate Ott
Else Kröner-Fresenius-Zentrum für ErnährungsmedizinLehrstuhl für ErnährungsmedizinTechnische Universität München
Outcome results
None listed