Diet, Obesity and Genes (DiOGenes) (DIOGENES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University of Copenhagen.
Recruitment status was  Active, not recruiting
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diet, Obesity and Genes

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • For adults: reduction in abdominal fat mass, and improvement in risk factors for type-2 diabetes and CVD [ Time Frame: 6 Month ]

Estimated Enrollment: 1020
Study Start Date: January 2006
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: January 20, 2009
Health Authority: Denmark: National Board of Health
Belgium: Brussel, EU Commission with annual review

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

Additional relevant MeSH terms:
Metabolic Syndrome X
Cardiovascular Diseases
Obesity
Diabetes Mellitus, Type 2
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014