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ISRCTN
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ISRCTN25867281
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ClinicalTrials.gov identifier
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Public title
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Nutrient-gene interaction in human obesity: implications for dietary guidelines
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Scientific title
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Acronym
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NUGENOB
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Serial number at source
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QLRT-2000-00618
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Study hypothesis
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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.
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Ethics approval
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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.
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Study design
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Randomised parallel two-arm open-label trial
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Countries of recruitment
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Denmark, The Netherlands, Sweden, United Kingdom, Czech Republic, Spain
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Disease/condition/study domain
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Obesity
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Participants - inclusion criteria
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1. Body mass index (BMI) ≥30
2. White European (by self report)
3. Age 20-50 years
4. Pre-menopausal (women)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2001
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Anticipated end date
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31/12/2002
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Status of trial
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Completed
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Patient information material
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Target number of participants
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750
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Interventions
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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.
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Primary outcome measure(s)
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Weight loss
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Secondary outcome measure(s)
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1. Changes in waist circumference
2. Body composition assessed by bio-impedance
3. Fasting blood lipids
4. Insulin and glucose
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Sources of funding
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European Commission, 5th Framework Programme: Quality of Life and Management of Living Resources - Key Action I: Food, Nutrition and Health" (QLRT-2000-00618)
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Trial website
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http://www.nugenob.org
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16331300
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Contact name
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Prof
Thorkild
Sørensen
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Address
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H:S Institute of Preventive Medicine
Øster Søgade 18, 1
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City/town
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Copenhagen K
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Zip/Postcode
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DK-1357
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Country
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Denmark
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Tel
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+45 (0)3338 3880
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Fax
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+45 (0)3332 4240
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Email
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tias@ipm.hosp.dk
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Sponsor
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European Commission, Research Directorate-General
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Address
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Rue de la Loi 200
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City/town
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Bruxelles
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Zip/Postcode
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B-1049
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Country
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Belgium
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Email
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liam.breslin@cec.eu.int
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Date applied
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28/03/2006
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Last edited
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25/09/2009
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Date ISRCTN assigned
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04/05/2006
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