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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25867281
Enrollment
750
Registered
2006-05-04
Start date
2001-05-01
Completion date
Unknown
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

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-ener

Sponsors

European Commission, Research Directorate-General (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Weight loss

Secondary

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

Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026