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

This study has been completed.
Sponsor:
Collaborator:
Metabolife
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00302263
First received: March 13, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted

March 13, 2006
March 13, 2006
January 2005
Not Provided
  • Energy expenditure
  • substrate oxidation
  • catecholmamines
  • energy intake
  • subjective appetite sensations
  • sympathetic/parasympathetic ratio
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
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).

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Obesity
Drug: Metobes-compound
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
April 2005
Not Provided

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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00302263
KF11-282523
Not Provided
Not Provided
University of Copenhagen
Metabolife
Principal Investigator: Jens Kondrup, PhD Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
University of Copenhagen
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP