NCT00390637

Diet, Obesity and Genes (DiOGenes)

Diet, Obesity and Genes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Accepted

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".

Conditions

• Obesity
• Metabolic Syndrome
• Type 2 Diabetes
• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	High or low Glycemic Index and high or low Protein Diet

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-03-01
• Completion: 2009-12-01
• First posted: 2006-10-20
• Last updated: 2018-10-25

Locations

1 site across 1 country: Denmark