Diet, Obesity and Genes (DiOGenes)

Obesity Clinical Trial

— DIOGENES  

Official title:

Diet, Obesity and Genes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390637
• Other study ID #: DiOGenes FP6-2005-513946
• Secondary ID: FOOD-2004-513946
• Status: Completed
• Phase: Phase 4
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: October 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: December 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria:

• Families with healthy adults and children

Exclusion Criteria:

• Various

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Denmark	Arne V. Astrup	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	European Commission

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Saris WH, Harper A. DiOGenes: a multidisciplinary offensive focused on the obesity epidemic. Obes Rev. 2005 May;6(2):175-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For adults: Identify traits biological that determine responses to the dietary intervention.	To identify biological traits that determine the family's and individual's responses to the dietary interventions.	12 months
Other	For adults: Identify psychological traits that determine responses to the dietary intervention.	To identify psychological traits that determine the family's and individual's responses to the dietary interventions.	12 months
Other	For adults: Identify traits gene - diet interactions that determine responses to the dietary intervention.	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.	12 months
Primary	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	For adults: change in body composition	The relative loss or gain of fat mass and fat free mass	6 Month
Secondary	For adults: More than 5% weight loss maintenance	Achievement of 5% of body weight loss from randomization	6 month
Secondary	For adults: More than 10% weight loss maintenance	Achievement of 10% of body weight loss from randomization	6 month
Secondary	For adults: Drop out rate	Percentage drop out from randomisation to end of dietary intervention	6 month
Secondary	For Adults: Change in risk factors for type-2 diabetes	Change in risk factors for type-2 diabetes	6 month
Secondary	For Adults: Change in risk factors for cardiovascular disease	Change in risk factors for cardiovascular disease	6 month
Secondary	For children: Change in body weight	Change in body weight from randomization to end of intervention	6 month
Secondary	For Children: Change in BMI-Z-score	Change in BMI-Z-score from randomisation to end of intervention	6 month

External Links

•   Diogenes study homepage