Overview

This trial is active, not recruiting.

Conditions obesity, metabolic syndrome, type 2 diabetes, cardiovascular disease
Treatment high or low glycemic index and high or low protein diet
Phase phase 4
Sponsor University of Copenhagen
Collaborator European Commission
Start date January 2006
End date December 2007
Trial size 1020 participants
Trial identifier NCT00390637, DiOGenes FP6-2005-513946, FOOD-2004-513946

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Low Protein, Low GI Diet
high or low glycemic index and high or low protein diet
(Experimental)
Low Protein, High Glycemic Index Diet
high or low glycemic index and high or low protein diet
(Experimental)
High Protein, Low Glycemic Index diet
high or low glycemic index and high or low protein diet
(Experimental)
High Protein, High glycemic index diet
high or low glycemic index and high or low protein diet
(Experimental)
Control diet (current recommendations)
high or low glycemic index and high or low protein diet

Primary Outcomes

Measure
For adults: body weight loss maintained, body composition, proportion of subjects maintaining > 0, 5 and 10% weight loss, and drop-out rate
time frame: 6 Month

Secondary Outcomes

Measure
For adults: reduction in abdominal fat mass, and improvement in risk factors for type-2 diabetes and CVD
time frame: 6 Month

Eligibility Criteria

Male or female participants from 5 years up to 65 years old.

Inclusion Criteria: - Families with healthy adults and children Exclusion Criteria: - Various

Additional Information

Official title Diet, Obesity and Genes
Principal investigator Arne V Astrup, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by University of Copenhagen.