Skip to main content
OpenTrials
Completed

NCT Number: NCT00390637

Diet, Obesity and Genes (DiOGenes)

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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:

  • Clinical examination 1 with anthropometry, blood etc.
  • 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day)(Adults only)
  • Clinical examination 2 with anthropometry, blood etc.
  • 6 months dietary intervention period 1 (SUPERMARKET period)(Family)
  • Clinical examination 3 with anthropometry, blood etc.
  • 6 months dietary intervention period 2 (DIETARY INSTRUCTION period)(Family).
  • Clinical examination 4 with anthropometry, blood ect.
  • 12 months free-living period with no dietary intervention. (Family)
  • Follow up (only body weight registration)

The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic)

Dietary periods and clinical examinations:

  • Clinical examination 1 with anthropometry, blood etc.
  • 8 week Low Calorie Diet (LCD) period (800-1000 kcal/day). (Adults only)
  • Clinical examination 2 with anthropometry, blood etc.
  • 6 months dietary intervention period (DIETARY INSTRUCTION period). (Family)
  • Clinical examination 3 with anthropometry, blood etc.
  • 6 months free-living period with no dietary intervention. (Family)
  • 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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Families with healthy adults and children

Exclusion criteria

  • Various

Treatment and study plan

High or low Glycemic Index and high or low Protein Diet

Behavioral

Primary outcomes

  1. 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 outcomes

  1. For adults: change in body composition

    Time frame: 6 Month

    The relative loss or gain of fat mass and fat free mass

  2. For adults: More than 5% weight loss maintenance

    Time frame: 6 month

    Achievement of 5% of body weight loss from randomization

  3. For adults: More than 10% weight loss maintenance

    Time frame: 6 month

    Achievement of 10% of body weight loss from randomization

  4. For adults: Drop out rate

    Time frame: 6 month

    Percentage drop out from randomisation to end of dietary intervention

  5. For Adults: Change in risk factors for type-2 diabetes

    Time frame: 6 month

    Change in risk factors for type-2 diabetes

  6. For Adults: Change in risk factors for cardiovascular disease

    Time frame: 6 month

    Change in risk factors for cardiovascular disease

  7. For children: Change in body weight

    Time frame: 6 month

    Change in body weight from randomization to end of intervention

  8. For Children: Change in BMI-Z-score

    Time frame: 6 month

    Change in BMI-Z-score from randomisation to end of intervention

Other outcomes

  1. 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.

  2. 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.

  3. For adults: Identify traits gene - diet interactions that determine responses to the dietary intervention.

    Time frame: 12 months

    To identify gene - diet interactions (e.g. SNP x dietary intake or copy number x dietary intake) that determine the family's and individual's responses to the dietary interventions.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • European Commission

Registry information

Official study title

Diet, Obesity and Genes

Acronym: DIOGENES

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Oct 20, 2006
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.