Diet, Obesity and Genes
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Copenhagen
- Enrollment
- 1020
- Locations
- 1
- Primary Endpoint
- For adults: body weight loss maintenance
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.
Detailed Description
DiOGenes is a randomised controlled dietary intervention study in obese/overweight families (adults and children) in 8 different European countries, testing the efficacy and safety of diets differing in Glycaemic Index (GI) and protein content. The 8 centres are divided into "shop centers" and "instruction centers", that provide different kind of dietary intervention and for a different length(see below): The 2 Shop Centers (Denmark \& The Netherlands): Dietary periods and clinical examinations: 1. Clinical examination 1 with anthropometry, blood etc. 2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only) 3. Clinical examination 2 with anthropometry, blood etc. 4. 6 months dietary intervention period 1 (SUPERMARKET period)(Family) 5. Clinical examination 3 with anthropometry, blood etc. 6. 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family). 7. Clinical examination 4 with anthropometry, blood ect. 8. 12 months free-living period with no dietary intervention. (Family) 9. Follow up (only body weight registration) The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic) Dietary periods and clinical examinations: 1. Clinical examination 1 with anthropometry, blood etc. 2. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only) 3. Clinical examination 2 with anthropometry, blood etc. 4. 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family) 5. Clinical examination 3 with anthropometry, blood etc. 6. 6 months free-living period with no dietary intervention. (Family) 7. Follow up (only body weight registration) Note that, during the first 6 month intervention all families from the shop centers are provided all foods free of charge "SUPERMARKET PERIOD", whereas in the "Instruction Centers", the families receive dietary instruction only "Instruction Only".
Investigators
Arne Astrup
Head of Department
University of Copenhagen
Eligibility Criteria
Inclusion Criteria
- •Families with healthy adults and children
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
For adults: body weight loss maintenance
Time Frame: 6 Month
The primary outcome is related to body weight loss maintenance after 6 month of intensive, homogeneous and therefore comparable dietary intervention across all 8 centres.
Secondary Outcomes
- For adults: More than 10% weight loss maintenance(6 month)
- For adults: Drop out rate(6 month)
- For Children: Change in BMI-Z-score(6 month)
- For Adults: Change in risk factors for type-2 diabetes(6 month)
- For Adults: Change in risk factors for cardiovascular disease(6 month)
- For adults: change in body composition(6 Month)
- For adults: More than 5% weight loss maintenance(6 month)
- For children: Change in body weight(6 month)