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

Sponsors and Collaborators:	University of Copenhagen Metabolife
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00302263

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 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)

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Obesity 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

Ages Eligible for Study:	18 Years to 50 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Keywords provided by University of Copenhagen:

Green tea
capsaicin
tyrosine

caffeine
energy expenditure
catecholamines

Study placed in the following topic categories:

Caffeine citrate
Obesity
Tyrosine
Overweight
Capsaicin
Body Weight
Signs and Symptoms

Tea
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Caffeine

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 02, 2009