Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
  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:

  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 Intervention Phase
Obesity
 Drug: Metobes-compound
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

Resource links provided by NLM:

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:

  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.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00302263     History of Changes
Other Study ID Numbers: KF11-282523 
Study First Received: March 13, 2006
Last Updated: March 13, 2006
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

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 28, 2016