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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302276
• Other study ID #: KF11-150/03
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 13, 2006
• Last updated: January 20, 2009
• Start date: January 2004
• Est. completion date: July 2004

Study information

• Verified date: November 2004
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Metobes-compound

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, The Royal Veterinary and Agricultural University	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight, fat mass, fat free mass, energy expenditure, respiratory quotient, fecal fat, fecal energy
Secondary	blood pressure, heart rate, urine catecholamines, self-reported adverse events