Nutrient-gene interaction in human obesity: implications for dietary guidelines

ISRCTN ISRCTN25867281
DOI https://doi.org/10.1186/ISRCTN25867281
Secondary identifying numbers QLRT-2000-00618
Submission date
28/03/2006
Registration date
04/05/2006
Last edited
14/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Thorkild Sørensen
Scientific

H:S Institute of Preventive Medicine
Øster Søgade 18, 1
Copenhagen
DK-1357
Denmark

Phone +45 (0)3338 3880
Email tias@ipm.hosp.dk

Study information

Study designRandomised parallel two-arm open-label trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleGenetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets
Study acronymNUGENOB
Study objectivesThere is an interaction between nutrient composition of the diet - more specifically the fat content - and obesity-related genes in the response to dietary treatment of human obesity.
Ethics approval(s)The study has received appropriate ethics committee approval. Denmark reference number: 01-083/01, 6/07/2001. The Netherlands: reference number: 01-058.3, 27/04/2001. Sweden: reference number: 127/01, 7/05/2001. United Kingdom reference number: GM040103, 14/05/2001. Czech Republic: 12/06/2001. France: reference number: 2-01-12/2, 30/03/2001. Spain: 5/04/2001.
Health condition(s) or problem(s) studiedObesity
InterventionOne-day clinical investigation examining responses to high fat test meal in lean and obese subjects followed by randomised, parallel, two-arm, open label, 10-week dietary intervention of two hypo-energetic diets with high and low fat content respectively in obese subjects.

Patients are randomised to receive two hypo-energetic diets with low-fat or high fat content.
Intervention typeOther
Primary outcome measureWeight loss
Secondary outcome measures1. Changes in waist circumference
2. Body composition assessed by bio-impedance
3. Fasting blood lipids
4. Insulin and glucose
Overall study start date01/05/2001
Completion date31/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants750
Total final enrolment755
Key inclusion criteria1. Body mass index (BMI) ≥30
2. White European (by self report)
3. Age 20-50 years
4. Pre-menopausal (women)
Key exclusion criteria1. Drug-treated hypertension
2. Drug-treated diabetes
3. Drug-treated hyperlipidaemia
4. Drug-treated thyroid disease
5. Use of anorexigenic agents
6. Anti-epileptic drugs
7. Anti-Parkinsonian drugs
8. Use of barbituates, benzodiasapines, beta-blockers, butyrophenones, carbonic anhydrase inhibitors, diuretics, dopamine reuptake inhibitors, digoxin, fibrates, fish oil supplement, glucocorticoids, immunosuppressives, insulin , laxatives, monoamine oxidase (MAO) inhibitors, niacin (>150 mg per day), nicotine, oral hypoglycemics, orlistat, phenothiazines, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, statins, thyroid hormone, triamterene, tricyclic antidepressants, warfarin or zonisamide
9. Surgically-treated obesity
10. Participation in ongoing drug trials
11. Pregnant women
12. Alcohol or drug abuse
13. Weight change of >3 kg within 3 months prior to clinical investigation day
Date of first enrolment01/05/2001
Date of final enrolment31/12/2002

Locations

Countries of recruitment

  • Czech Republic
  • Denmark
  • France
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study participating centre

H:S Institute of Preventive Medicine
Copenhagen
DK-1357
Denmark

Sponsor information

European Commission, Research Directorate-General (Belgium)
Other

Rue de la Loi 200
Bruxelles
B-1049
Belgium

Phone +32 (0)2 295 04 77
Email liam.breslin@cec.eu.int
Website http://ec.europa.eu/dgs/research/index_en.html
ROR logo "ROR" https://ror.org/00k4n6c32

Funders

Funder type

Other

European Commission, 5th Framework Programme: Quality of Life and Management of Living Resources - Key Action I: Food, Nutrition and Health" (QLRT-2000-00618)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2006 Yes No
Results article results 01/06/2012 Yes No
Results article 13/07/2021 14/07/2021 Yes No

Editorial Notes

14/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
06/02/2019: The trial website has been removed.
22/05/2017: France has been added to the countries of recruitment.