Diet, Obesity and Genes (DiOGenes) (DIOGENES)

University of Copenhagen

Status and phase: Completed; Phase 4

Conditions: Obesity; Type 2 Diabetes; Metabolic Syndrome; Cardiovascular Disease

Treatments: Behavioral: High or low Glycemic Index and high or low Protein Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00390637

DiOGenes FP6-2005-513946

FOOD-2004-513946

Details and patient eligibility

About

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.

Full 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".

Enrollment: 1,020 estimated patients

Sex: All

Ages: 5 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Families with healthy adults and children

Exclusion criteria

• Various

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,020 participants in 5 patient groups

1

Experimental group

Description:

Low Protein, Low GI Diet

Treatment:

Behavioral: High or low Glycemic Index and high or low Protein Diet

2

Experimental group

Description:

Low Protein, High Glycemic Index Diet

Treatment:

Behavioral: High or low Glycemic Index and high or low Protein Diet

3

Experimental group

Description:

High Protein, Low Glycemic Index diet

Treatment:

Behavioral: High or low Glycemic Index and high or low Protein Diet

4

Experimental group

Description:

High Protein, High glycemic index diet

Treatment:

Behavioral: High or low Glycemic Index and high or low Protein Diet

5

Experimental group

Description:

Control diet (current recommendations)

Treatment:

Behavioral: High or low Glycemic Index and high or low Protein Diet