Cardiovascular Disease, Metabolic Syndrome, Obesity, Type 2 Diabetes
Conditions
Keywords
Diogenes, Diet Intervention, Family, Glycemic Index, Protein
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Families with healthy adults and children
Exclusion criteria
* Various
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For adults: body weight loss maintenance | 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
| Measure | Time frame | Description |
|---|---|---|
| For adults: Drop out rate | 6 month | Percentage drop out from randomisation to end of dietary intervention |
| For Adults: Change in risk factors for cardiovascular disease | 6 month | Change in risk factors for cardiovascular disease |
| For children: Change in body weight | 6 month | Change in body weight from randomization to end of intervention |
| For Children: Change in BMI-Z-score | 6 month | Change in BMI-Z-score from randomisation to end of intervention |
| For adults: change in body composition | 6 Month | The relative loss or gain of fat mass and fat free mass |
| For adults: More than 5% weight loss maintenance | 6 month | Achievement of 5% of body weight loss from randomization |
| For adults: More than 10% weight loss maintenance | 6 month | Achievement of 10% of body weight loss from randomization |
| For Adults: Change in risk factors for type-2 diabetes | 6 month | Change in risk factors for type-2 diabetes |
Other
| Measure | Time frame | Description |
|---|---|---|
| For adults: Identify traits gene - diet interactions that determine responses to the dietary intervention. | 12 months | To identify gene - diet interactions (e.g. SNP x dietary intake or copy number x dietary intake) that determine the family's and individual's responses to the dietary interventions. |
| For adults: Identify psychological traits that determine responses to the dietary intervention. | 12 months | To identify psychological traits that determine the family's and individual's responses to the dietary interventions. |
| For adults: Identify traits biological that determine responses to the dietary intervention. | 12 months | To identify biological traits that determine the family's and individual's responses to the dietary interventions. |
Countries
Denmark