Obesity Clinical Trial - Diet, Obesity & Genes (DiOGenes)

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00390637
Study type	Interventional
Source	University of Copenhagen
Contact
Status	Completed
Phase	Phase 4
Start date	January 2006
Completion date	December 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diet, Obesity and Genes (DiOGenes) — DIOGENES

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms