Arne V. Astrup
Copenhagen, Denmark
NCT Number: NCT00390637
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.
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Notify Me5 year–65 year
All sexes
Interventional
Phase 4
Copenhagen, Denmark
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:
The 6 Instruction Centers (UK, Crete, Germany, Spain, Bulgaria, Czech Republic)
Dietary periods and clinical examinations:
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".
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 Month
The relative loss or gain of fat mass and fat free mass
Time frame: 6 month
Achievement of 5% of body weight loss from randomization
Time frame: 6 month
Achievement of 10% of body weight loss from randomization
Time frame: 6 month
Percentage drop out from randomisation to end of dietary intervention
Time frame: 6 month
Change in risk factors for type-2 diabetes
Time frame: 6 month
Change in risk factors for cardiovascular disease
Time frame: 6 month
Change in body weight from randomization to end of intervention
Time frame: 6 month
Change in BMI-Z-score from randomisation to end of intervention
Time frame: 12 months
To identify biological traits that determine the family's and individual's responses to the dietary interventions.
Time frame: 12 months
To identify psychological traits that determine the family's and individual's responses to the dietary interventions.
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.
University of Copenhagen
Other
Diet, Obesity and Genes
Acronym: DIOGENES
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.
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