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Sponsors and Collaborators: |
University of Copenhagen Metabolife |
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Information provided by: | University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT00302263 |
To investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad libitum food intake after intake of the Metobes-compound (green tea extract, capsaicin, tyrosine, caffeine). Furthermore, to investigate if the effect of the Metobes-compound can be inhibited by blocking the β-adrenergic receptors.
The effect of the Metobes-compound will be investigated by:
Condition | Intervention | Phase |
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Obesity |
Drug: Metobes-compound |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long) |
Estimated Enrollment: | 22 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | April 2005 |
Subjects 22 healthy Danish overweight to obese men (BMI between 25 and 35 kg/m2), 18 to 50 years of age. All subjects must be weight stable (within 3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication.
Method The study is designed as a 4-way crossover, randomised, placebo controlled, double-blind study. Each treatment will be separated by >1-week washout period. The treatments will consist of:
On each test day body weight and composition will be assessed. All subjects will undergo a 5-h post dose assessment of energy expenditure by indirect calorimetry in a ventilated hood. Subjective appetite sensations, ECG and dual measures of blood pressure/heart rate will be assessed every 30 minutes. After completed respiratory measurements the subjects will be served an ad libitum lunch meal (pasta salad).
All subjects shall collect all urine excreted during the respiratory measurements. Urine samples will be analyzed for nitrogen content and content of catecholamines.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Human Nutrition, The Royal Veterinary and Agricultural University | |
Frederiksberg, Denmark, 1958 |
Principal Investigator: | Jens Kondrup, PhD | Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark |
Study ID Numbers: | KF11-282523 |
Study First Received: | March 13, 2006 |
Last Updated: | March 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00302263 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Green tea capsaicin tyrosine |
caffeine energy expenditure catecholamines |
Caffeine citrate Obesity Tyrosine Overweight Capsaicin Body Weight Signs and Symptoms |
Tea Weight Loss Body Weight Changes Nutrition Disorders Overnutrition Caffeine |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |