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

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00302276
First received: March 13, 2006
Last updated: January 20, 2009
Last verified: November 2004
  Purpose

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.


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

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

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

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

Estimated Enrollment: 80
Study Start Date: January 2004
Estimated Study Completion Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00302276

Locations
Denmark
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Jens Kondrup, Prof Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00302276     History of Changes
Other Study ID Numbers: KF11-150/03
Study First Received: March 13, 2006
Last Updated: January 20, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Body fat loss
energy expenditure
capsaicin
caffeine
green tea
calcium
fecal fat
fecal energy

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

ClinicalTrials.gov processed this record on September 16, 2014