This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Diet, Obesity and Genes (DiOGenes) (DIOGENES)

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00390637
First received: October 18, 2006
Last updated: May 29, 2017
Last verified: May 2017
October 18, 2006
May 29, 2017
January 2006
March 2008   (Final data collection date for primary outcome measure)
For adults: body weight loss maintenance [ Time Frame: 6 Month ]
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.
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: change in body composition [ Time Frame: 6 Month ]
    The relative loss or gain of fat mass and fat free mass
  • For adults: More than 5% weight loss maintenance [ Time Frame: 6 month ]
    Achievement of 5% of body weight loss from randomization
  • For adults: More than 10% weight loss maintenance [ Time Frame: 6 month ]
    Achievement of 10% of body weight loss from randomization
  • For adults: Drop out rate [ Time Frame: 6 month ]
    Percentage drop out from randomisation to end of dietary intervention
  • For Adults: Change in risk factors for type-2 diabetes [ Time Frame: 6 month ]
    Change in risk factors for type-2 diabetes
  • For Adults: Change in risk factors for cardiovascular disease [ Time Frame: 6 month ]
    Change in risk factors for cardiovascular disease
  • For children: Change in body weight [ Time Frame: 6 month ]
    Change in body weight from randomization to end of intervention
  • For Children: Change in BMI-Z-score [ Time Frame: 6 month ]
    Change in BMI-Z-score from randomisation to end of intervention
For adults: reduction in abdominal fat mass, and improvement in risk factors for type-2 diabetes and CVD
  • For adults: Identify traits biological that determine responses to the dietary intervention. [ Time Frame: 12 months ]
    To identify biological traits that determine the family's and individual's responses to the dietary interventions.
  • For adults: Identify psychological traits that determine responses to the dietary intervention. [ Time Frame: 12 months ]
    To identify psychological traits that determine the family's and individual's responses to the dietary interventions.
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.

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".

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
1020
December 2009
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Families with healthy adults and children

Exclusion Criteria:

  • Various
Sexes Eligible for Study: 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
Arne Astrup, University of Copenhagen
University of Copenhagen
European Commission
Principal Investigator: Arne V Astrup, Professor Institute of Human Nutrition, RVAU, Denmark
University of Copenhagen
May 2017

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