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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
  Purpose
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.

Condition Intervention Phase
Obesity Metabolic Syndrome Type 2 Diabetes Cardiovascular Disease Behavioral: High or low Glycemic Index and high or low Protein Diet Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diet, Obesity and Genes

Resource links provided by NLM:


Further study details as provided by Arne Astrup, University of Copenhagen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 1020
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low Protein, Low GI Diet
Behavioral: High or low Glycemic Index and high or low Protein Diet
Experimental: 2
Low Protein, High Glycemic Index Diet
Behavioral: High or low Glycemic Index and high or low Protein Diet
Experimental: 3
High Protein, Low Glycemic Index diet
Behavioral: High or low Glycemic Index and high or low Protein Diet
Experimental: 4
High Protein, High glycemic index diet
Behavioral: High or low Glycemic Index and high or low Protein Diet
Experimental: 5
Control diet (current recommendations)
Behavioral: High or low Glycemic Index and high or low Protein Diet

Detailed 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".

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Families with healthy adults and children

Exclusion Criteria:

  • Various
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390637

Locations
Denmark
Arne V. Astrup
Copenhagen, Denmark
Sponsors and Collaborators
University of Copenhagen
European Commission
Investigators
Principal Investigator: Arne V Astrup, Professor Institute of Human Nutrition, RVAU, Denmark
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Arne Astrup, Head of Department, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00390637     History of Changes
Other Study ID Numbers: DiOGenes FP6-2005-513946
FOOD-2004-513946
Study First Received: October 18, 2006
Last Updated: May 29, 2017

Keywords provided by Arne Astrup, University of Copenhagen:
Diogenes
Diet Intervention
Family
Glycemic Index
Protein

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 25, 2017