Nutrient-gene interaction in human obesity: implications for dietary guidelines
| ISRCTN | ISRCTN25867281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25867281 |
| Protocol serial number | QLRT-2000-00618 |
| Sponsor | European Commission, Research Directorate-General (Belgium) |
| Funder | European Commission, 5th Framework Programme: Quality of Life and Management of Living Resources - Key Action I: Food, Nutrition and Health" (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
Scientific
H:S Institute of Preventive Medicine
Øster Søgade 18, 1
Copenhagen
DK-1357
Denmark
| Phone | +45 (0)3338 3880 |
|---|---|
| tias@ipm.hosp.dk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised parallel two-arm open-label trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Genetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets |
| Study acronym | NUGENOB |
| Study objectives | There 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) studied | Obesity |
| Intervention | One-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 type | Other |
| Primary outcome measure(s) |
Weight loss |
| Key secondary outcome measure(s) |
1. Changes in waist circumference |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 750 |
| Total final enrolment | 755 |
| Key inclusion criteria | 1. Body mass index (BMI) ≥30 2. White European (by self report) 3. Age 20-50 years 4. Pre-menopausal (women) |
| Key exclusion criteria | 1. 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 enrolment | 01/05/2001 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- United Kingdom
- Czech Republic
- Denmark
- France
- Netherlands
- Spain
- Sweden
Study participating centre
H:S Institute of Preventive Medicine
Copenhagen
DK-1357
Denmark
DK-1357
Denmark
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
