Diet, Obesity and Genes (DiOGenes)

Phase 4

Completed

• Conditions: Type 2 Diabetes; Obesity; Cardiovascular Disease; Metabolic Syndrome
• Interventions: Behavioral: High or low Glycemic Index and high or low Protein Diet

• Registration Number: NCT00390637
• Lead Sponsor: University of Copenhagen

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".

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-20
• Primary Completion: 2008-03
• Study Completion: 2009-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

• Families with healthy adults and children

Exclusion Criteria

• Various

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	High or low Glycemic Index and high or low Protein Diet	High Protein, High glycemic index diet
2	High or low Glycemic Index and high or low Protein Diet	Low Protein, High Glycemic Index Diet
1	High or low Glycemic Index and high or low Protein Diet	Low Protein, Low GI Diet
3	High or low Glycemic Index and high or low Protein Diet	High Protein, Low Glycemic Index diet
5	High or low Glycemic Index and high or low Protein Diet	Control diet (current recommendations)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
For adults: More than 10% weight loss maintenance	6 month	Achievement of 10% of body weight loss from randomization
For adults: Drop out rate	6 month	Percentage drop out from randomisation to end of dietary 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 risk factors for type-2 diabetes	6 month	Change in risk factors for type-2 diabetes
For Adults: Change in risk factors for cardiovascular disease	6 month	Change in risk factors for cardiovascular disease
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 children: Change in body weight	6 month	Change in body weight from randomization to end of intervention

Trial Locations

Locations (1)

Arne V. Astrup; 🇩🇰 Copenhagen, Denmark