B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Metobes-compound
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Green tea, capsaicin, tyrosine, caffeine, energy expenditure, catecholamines
Eligibility 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.
Sites / Locations
- Department of Human Nutrition, The Royal Veterinary and Agricultural University
Outcomes
Primary Outcome Measures
Energy expenditure
substrate oxidation
catecholmamines
energy intake
subjective appetite sensations
sympathetic/parasympathetic ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT00302263
First Posted
March 13, 2006
Last Updated
March 13, 2006
Sponsor
University of Copenhagen
Collaborators
Metabolife
1. Study Identification
Unique Protocol Identification Number
NCT00302263
Brief Title
B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Official Title
B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
Metabolife
4. Oversight
5. Study Description
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:
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Green tea, capsaicin, tyrosine, caffeine, energy expenditure, catecholamines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
22 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metobes-compound
Primary Outcome Measure Information:
Title
Energy expenditure
Title
substrate oxidation
Title
catecholmamines
Title
energy intake
Title
subjective appetite sensations
Title
sympathetic/parasympathetic ratio
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kondrup, PhD
Organizational Affiliation
Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition, The Royal Veterinary and Agricultural University
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
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B181 Metobes-III: Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
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