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
Hospitals
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, France, 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
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
-
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.
-
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.