Diet, Obesity and Genes (DiOGenes)

Study Overview
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Brief Summary
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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
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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: Clinical examination 1 with anthropometry, blood etc. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only) Clinical examination 2 with anthropometry, blood etc. 6 months dietary intervention period 1 (SUPERMARKET period)(Family) Clinical examination 3 with anthropometry, blood etc. 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family). Clinical examination 4 with anthropometry, blood ect. 12 months free-living period with no dietary intervention. (Family) Follow up (only body weight registration) The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic) Dietary periods and clinical examinations: Clinical examination 1 with anthropometry, blood etc. 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only) Clinical examination 2 with anthropometry, blood etc. 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family) Clinical examination 3 with anthropometry, blood etc. 6 months free-living period with no dietary intervention. (Family) 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.

Official Title
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Diet, Obesity and Genes

Conditions
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Obesity, Metabolic Syndrome, Type 2 Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: High or low Glycemic Index and high or low Protein Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Families with healthy adults and children Exclusion Criteria: Various

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low Protein, Low GI Diet | Behavioral: High or low Glycemic Index and high or low Protein Diet<br> <br> |
| Experimental: 2<br>Low Protein, High Glycemic Index Diet | Behavioral: High or low Glycemic Index and high or low Protein Diet<br> <br> |
| Experimental: 3<br>High Protein, Low Glycemic Index diet | Behavioral: High or low Glycemic Index and high or low Protein Diet<br> <br> |
| Experimental: 4<br>High Protein, High glycemic index diet | Behavioral: High or low Glycemic Index and high or low Protein Diet<br> <br> |
| Experimental: 5<br>Control diet (current recommendations) | Behavioral: High or low Glycemic Index and high or low Protein Diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For adults: body weight loss maintenance | 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. | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For adults: change in body composition | The relative loss or gain of fat mass and fat free mass | 6 Month | 
| For adults: More than 5% weight loss maintenance | Achievement of 5% of body weight loss from randomization | 6 month | 
| For adults: More than 10% weight loss maintenance | Achievement of 10% of body weight loss from randomization | 6 month | 
| For adults: Drop out rate | Percentage drop out from randomisation to end of dietary intervention | 6 month | 
| For Adults: Change in risk factors for type-2 diabetes | Change in risk factors for type-2 diabetes | 6 month | 
| For Adults: Change in risk factors for cardiovascular disease | Change in risk factors for cardiovascular disease | 6 month | 
| For children: Change in body weight | Change in body weight from randomization to end of intervention | 6 month | 
| For Children: Change in BMI-Z-score | Change in BMI-Z-score from randomisation to end of intervention | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diogenes, Diet Intervention, Family, Glycemic Index, Protein