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

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ClinicalTrials.gov Identifier: NCT00302263
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : March 14, 2006
Sponsor:
Collaborator:
Metabolife
Information provided by:
University of Copenhagen

Study Description
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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:

  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).

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:

  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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 22 participants
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 : January 2005
Study Completion Date : April 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Energy expenditure
  2. substrate oxidation
  3. catecholmamines
  4. energy intake
  5. subjective appetite sensations
  6. sympathetic/parasympathetic ratio

Eligibility Criteria
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00302263     History of Changes
Other Study ID Numbers: KF11-282523
First Posted: March 14, 2006    Key Record Dates
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