Diet, Obesity and Genes (DiOGenes) (DIOGENES)

October 23, 2018 updated by: Arne Astrup, University of Copenhagen

Diet, Obesity and Genes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Anticipated)

1020

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Arne V. Astrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Families with healthy adults and children

Exclusion Criteria:

  • Various

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For adults: change in body composition
Time Frame: 6 Month
The relative loss or gain of fat mass and fat free mass
6 Month
For adults: More than 5% weight loss maintenance
Time Frame: 6 month
Achievement of 5% of body weight loss from randomization
6 month
For adults: More than 10% weight loss maintenance
Time Frame: 6 month
Achievement of 10% of body weight loss from randomization
6 month
For adults: Drop out rate
Time Frame: 6 month
Percentage drop out from randomisation to end of dietary intervention
6 month
For Adults: Change in risk factors for type-2 diabetes
Time Frame: 6 month
Change in risk factors for type-2 diabetes
6 month
For Adults: Change in risk factors for cardiovascular disease
Time Frame: 6 month
Change in risk factors for cardiovascular disease
6 month
For children: Change in body weight
Time Frame: 6 month
Change in body weight from randomization to end of intervention
6 month
For Children: Change in BMI-Z-score
Time Frame: 6 month
Change in BMI-Z-score from randomisation to end of intervention
6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

European Commission

Investigators

  • Principal Investigator: Arne V Astrup, Professor, Institute of Human Nutrition, RVAU, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 18, 2006

First Submitted That Met QC Criteria

October 18, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiOGenes FP6-2005-513946
  • FOOD-2004-513946

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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