Skip to content

Diet, Obesity and Genes (DiOGenes)

Diet, Obesity and Genes

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00390637
Acronym
DIOGENES
Enrollment
1020
Registered
2006-10-20
Start date
2006-01-31
Completion date
2009-12-31
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Metabolic Syndrome, Obesity, Type 2 Diabetes

Keywords

Diogenes, Diet Intervention, Family, Glycemic Index, Protein

Brief summary

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.

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.

Interventions

BEHAVIORALHigh or low Glycemic Index and high or low Protein Diet

Sponsors

European Commission
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Families with healthy adults and children

Exclusion criteria

* Various

Design outcomes

Primary

MeasureTime frameDescription
For adults: body weight loss maintenance6 MonthThe 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

MeasureTime frameDescription
For adults: Drop out rate6 monthPercentage drop out from randomisation to end of dietary intervention
For Adults: Change in risk factors for cardiovascular disease6 monthChange in risk factors for cardiovascular disease
For children: Change in body weight6 monthChange in body weight from randomization to end of intervention
For Children: Change in BMI-Z-score6 monthChange in BMI-Z-score from randomisation to end of intervention
For adults: change in body composition6 MonthThe relative loss or gain of fat mass and fat free mass
For adults: More than 5% weight loss maintenance6 monthAchievement of 5% of body weight loss from randomization
For adults: More than 10% weight loss maintenance6 monthAchievement of 10% of body weight loss from randomization
For Adults: Change in risk factors for type-2 diabetes6 monthChange in risk factors for type-2 diabetes

Other

MeasureTime frameDescription
For adults: Identify traits gene - diet interactions that determine responses to the dietary intervention.12 monthsTo 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.
For adults: Identify psychological traits that determine responses to the dietary intervention.12 monthsTo identify psychological traits that determine the family's and individual's responses to the dietary interventions.
For adults: Identify traits biological that determine responses to the dietary intervention.12 monthsTo identify biological traits that determine the family's and individual's responses to the dietary interventions.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026