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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
University of Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Body fat loss, energy expenditure, capsaicin, caffeine, green tea, calcium, fecal fat, fecal energy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects must be weight stable (within 3-kg) 2 months prior to study inclusion. Exclusion Criteria: smokers, athletic, daily use of medication except for anticonception and antihypertensive compounds, blood pressure above 165/95 mmHg

Sites / Locations

  • Department of Human Nutrition, The Royal Veterinary and Agricultural University

Outcomes

Primary Outcome Measures

Body weight, fat mass, fat free mass, energy expenditure, respiratory quotient, fecal fat, fecal energy

Secondary Outcome Measures

blood pressure, heart rate, urine catecholamines, self-reported adverse events

Full Information

First Posted
March 13, 2006
Last Updated
January 20, 2009
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00302276
Brief Title
Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Official Title
Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen

4. Oversight

5. Study Description

Brief Summary
The objective of the present study was to investigate the acute and sub-chronic effect of a supplement containing green tea extract, capsaisin, caffeine, tyrosine and calcium or placebo taken t.i.d on thermogenesis, body fat loss, and fecal fat excretion. Furthermore, if a 8-week supplementation could prevent weight-regain after initial 4-week weight loss.
Detailed Description
It has previously been shown that a combination of tyrosine, capsaicin, catechines, and caffeine may stimulate the sympathetic nervous system and promote satiety, lipolysis and thermogenesis. In addition, dietary calcium may increase fecal fat excretion. Method: 80 healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects was be weight stable (within 3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication except for anticonception and antihypertensive compounds. All subjects gave their written consent after verbal and written information about the study. The study protocol was approved by The Municipal Ethical Committee of Copenhagen and Frederiksberg as being in accordance with the Helsinki II Declaration. The total study period was 12 weeks. The intervention design was an 8-weeks randomized, 3-arm parallel, placebo-controlled and double-blind intervention. Prior to the randomized intervention a weight loss was initiated by 4 week treatment on a 3.4 MJ/d low caloric diet (LCD). Only subject who lost more than 4% of their initial body weight after 4 weeks LCD treatment was randomized and continued in the study. The subjects were randomized into 3 balanced groups i.e. placebo, simple or enterocoated release. All subjects received dietary instruction to a slightly hypo caloric diet of -300 kcal/day after the isoenergetic educational system. The dietary advice was reinforced by dietetic consultations every fortnight. Body weight and composition were assessed by DEXA before and after the LCD period, four weeks into the randomized period and at completion i.e. the last day of the study. All participants underwent assessment of energy expenditure by indirect calorimetry in a ventilated hood. The first respiratory measurement was on the first day of the intervention and will last for 5 hours. All subjects collected all feces excreted three days prior to respiratory measurement and one day of urine excreted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Body fat loss, energy expenditure, capsaicin, caffeine, green tea, calcium, fecal fat, fecal energy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Metobes-compound
Primary Outcome Measure Information:
Title
Body weight, fat mass, fat free mass, energy expenditure, respiratory quotient, fecal fat, fecal energy
Secondary Outcome Measure Information:
Title
blood pressure, heart rate, urine catecholamines, self-reported adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy Danish overweight to obese (BMI between 28 and 35 kg/m2), 18 to 70 years of age subjects of both gender. All subjects must be weight stable (within 3-kg) 2 months prior to study inclusion. Exclusion Criteria: smokers, athletic, daily use of medication except for anticonception and antihypertensive compounds, blood pressure above 165/95 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Kondrup, Prof
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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Weight Loss Maintenance of a New Bioactive Compound (Metobes-Long)

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