B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00302263

First Posted: March 14, 2006

Last Update Posted: March 14, 2006

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Collaborator:

Metabolife

Information provided by:

University of Copenhagen

Purpose

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:

5-hour energy expenditure and respiratory quotient (ventilated hood).
5-h change in blood pressure and heart rate
5-h change in sympathetic/parasympathetic ratio.
Ad libitum energy intake.
Self-reported postprandiel appetite sensations (VAS).

Condition	Intervention	Phase
Obesity	Drug: Metobes-compound	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Prevention
Official Title:	B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

Resource links provided by NLM:

MedlinePlus related topics: Body Weight Weight Control

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

Energy expenditure
substrate oxidation
catecholmamines
energy intake
subjective appetite sensations
sympathetic/parasympathetic ratio


Estimated Enrollment:	22
Study Start Date:	January 2005
Estimated Study Completion Date:	April 2005

Detailed Description:

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:

Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 5 mg propranolol.
Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 10 mg propranolol.
Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with a placebo tablet for propranolol (microcrystalline cellulose).
Placebo for the Metobes compound (microcrystalline cellulose) together with a placebo tablet for propranolol (microcrystalline cellulose).

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

21 healthy Danish normal-weight to obese men (BMI between 20 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.

Exclusion Criteria:

They will be excluded if they do not meet the inclusion criteria and/or the blood pressure is above 165/95 mmHg and/or the ECG is abnormal.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302263

Locations


Denmark
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, Denmark, 1958

Sponsors and Collaborators

University of Copenhagen

Metabolife

Investigators


Principal Investigator:	Jens Kondrup, PhD	Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark

More Information


ClinicalTrials.gov Identifier:	NCT00302263 History of Changes
Other Study ID Numbers:	KF11-282523
First Submitted:	March 13, 2006
First Posted:	March 14, 2006
Last Update Posted:	March 14, 2006
Last Verified:	August 2005

Keywords provided by University of Copenhagen:


Green tea capsaicin tyrosine	caffeine energy expenditure catecholamines

Additional relevant MeSH terms:


Weight Loss Body Weight Changes Body Weight Signs and Symptoms

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