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

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00302263

Collaborator

Metabolife (Industry)

Enrollment

Location

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Obesity	Drug: Metobes-compound	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

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)

Study Start Date :

Jan 1, 2005

Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.