Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/03/2006
Date assigned
04/05/2006
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nugenob.org

Contact information

Type

Scientific

Primary contact

Prof Thorkild Sørensen

ORCID ID

Contact details

H:S Institute of Preventive Medicine
Øster Søgade 18
1
Copenhagen
DK-1357
Denmark
+45 (0)3338 3880
tias@ipm.hosp.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

QLRT-2000-00618

Study information

Scientific title

Genetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets

Acronym

NUGENOB

Study hypothesis

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

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.

Study design

Randomised parallel two-arm open-label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Weight loss

Secondary outcome measures

1. Changes in waist circumference
2. Body composition assessed by bio-impedance
3. Fasting blood lipids
4. Insulin and glucose

Overall trial start date

01/05/2001

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Body mass index (BMI) ≥30
2. White European (by self report)
3. Age 20-50 years
4. Pre-menopausal (women)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

750

Participant 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

Recruitment start date

01/05/2001

Recruitment end date

31/12/2002

Locations

Countries of recruitment

Czech Republic, Denmark, Netherlands, Spain, Sweden, United Kingdom

Trial participating centre

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

Sponsor information

Organisation

European Commission, Research Directorate-General (Belgium)

Sponsor details

Rue de la Loi 200
Bruxelles
B-1049
Belgium
+32 (0)2 295 04 77
liam.breslin@cec.eu.int

Sponsor type

Other

Website

http://ec.europa.eu/dgs/research/index_en.html

Funders

Funder type

Other

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in www.ncbi.nlm.nih.gov/pubmed/16871334
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22952648

Publication citations

  1. Results

    Sørensen TI, Boutin P, Taylor MA, Larsen LH, Verdich C, Petersen L, Holst C, Echwald SM, Dina C, Toubro S, Petersen M, Polak J, Clément K, Martínez JA, Langin D, Oppert JM, Stich V, Macdonald I, Arner P, Saris WH, Pedersen O, Astrup A, Froguel P, , Genetic polymorphisms and weight loss in obesity: a randomised trial of hypo-energetic high- versus low-fat diets., PLoS Clin Trials, 2006, 1, 2, e12, doi: 10.1371/journal.pctr.0010012.

  2. Results

    Stocks T, Angquist L, Banasik K, Harder MN, Taylor MA, Hager J, Arner P, Oppert JM, Martinez JA, Polak J, Rousseau F, Langin D, Rössner S, Holst C, MacDonald IA, Kamatani Y, Pfeiffer AF, Kunesova M, Saris WH, Hansen T, Pedersen O, Astrup A, Sørensen TI, TFAP2B influences the effect of dietary fat on weight loss under energy restriction., PLoS ONE, 2012, 7, 8, e43212, doi: 10.1371/journal.pone.0043212.

Additional files

Editorial Notes