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Diet, Obesity and Genes (DiOGenes) (DIOGENES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Commission
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00390637
First received: October 18, 2006
Last updated: January 20, 2009
Last verified: November 2007

October 18, 2006
January 20, 2009
January 2006
Not Provided
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 ]
For adults: body weight loss maintained, body composition, proportion of subjects maintaining > 0, 5 and 10% weight loss, and drop-out rate
Complete list of historical versions of study NCT00390637 on ClinicalTrials.gov Archive Site
For adults: reduction in abdominal fat mass, and improvement in risk factors for type-2 diabetes and CVD [ Time Frame: 6 Month ]
For adults: reduction in abdominal fat mass, and improvement in risk factors for type-2 diabetes and CVD
Not Provided
Not Provided
 
Diet, Obesity and Genes (DiOGenes)
Diet, Obesity and Genes
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.
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Metabolic Syndrome
  • Type 2 Diabetes
  • Cardiovascular Disease
Behavioral: High or low Glycemic Index and high or low Protein Diet
  • Experimental: 1
    Low Protein, Low GI Diet
    Intervention: Behavioral: High or low Glycemic Index and high or low Protein Diet
  • Experimental: 2
    Low Protein, High Glycemic Index Diet
    Intervention: Behavioral: High or low Glycemic Index and high or low Protein Diet
  • Experimental: 3
    High Protein, Low Glycemic Index diet
    Intervention: Behavioral: High or low Glycemic Index and high or low Protein Diet
  • Experimental: 4
    High Protein, High glycemic index diet
    Intervention: Behavioral: High or low Glycemic Index and high or low Protein Diet
  • Experimental: 5
    Control diet (current recommendations)
    Intervention: Behavioral: High or low Glycemic Index and high or low Protein Diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1020
December 2007
Not Provided

Inclusion Criteria:

  • Families with healthy adults and children

Exclusion Criteria:

  • Various
All
5 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00390637
DiOGenes FP6-2005-513946, FOOD-2004-513946
Yes
Not Provided
Not Provided
Not Provided
University of Copenhagen
European Commission
Principal Investigator: Arne V Astrup, Professor Institute of Human Nutrition, RVAU, Denmark
University of Copenhagen
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP