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

Not Applicable
Conditions
Nutritional, Metabolic, Endocrine
Obesity
Registration Number
ISRCTN25867281
Lead Sponsor
European Commission, Research Directorate-General (Belgium)
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
755
Inclusion Criteria

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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Weight loss
Secondary Outcome Measures
NameTimeMethod
<br> 1. Changes in waist circumference<br> 2. Body composition assessed by bio-impedance<br> 3. Fasting blood lipids<br> 4. Insulin and glucose<br>
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