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NCT Number: NCT00302263

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

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metobes-compound

Drug

Primary outcomes

  1. Energy expenditure

  2. substrate oxidation

  3. catecholmamines

  4. energy intake

  5. subjective appetite sensations

  6. sympathetic/parasympathetic ratio

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Metabolife

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Mar 14, 2006
Registry last updated
Mar 14, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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