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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-04-30

Brief Summary

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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:

1. 5-hour energy expenditure and respiratory quotient (ventilated hood).
2. 5-h change in blood pressure and heart rate
3. 5-h change in sympathetic/parasympathetic ratio.
4. Ad libitum energy intake.
5. Self-reported postprandiel appetite sensations (VAS).

Detailed Description

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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:

1. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 5 mg propranolol.
2. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 10 mg propranolol.
3. Bioactive Metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with a placebo tablet for propranolol (microcrystalline cellulose).
4. 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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Metobes-compound

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jens Kondrup, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KF11-282523

Identifier Type: -

Identifier Source: org_study_id