Viewing Study NCT00390637



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00390637
Status: COMPLETED
Last Update Posted: 2018-10-25
First Post: 2006-10-18

Brief Title: Diet Obesity and Genes DiOGenes
Sponsor: University of Copenhagen
Organization: University of Copenhagen

Study Overview

Official Title: Diet Obesity and Genes
Status: COMPLETED
Status Verified Date: 2018-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DIOGENES
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 obeseoverweight 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 lengthsee 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 kcaldayAdults only
3 Clinical examination 2 with anthropometry blood etc
4 6 months dietary intervention period 1 SUPERMARKET periodFamily
5 Clinical examination 3 with anthropometry blood etc
6 6 months dietary intervention period 2 DIETARY INSTRUCTION periodFamily
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 kcalday 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
FOOD-2004-513946 None None None