B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

Obesity Clinical Trial

Official title:

B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302289
• Other study ID #: KF01-188/00
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2006
• Last updated: March 13, 2006
• Start date: January 2000
• Est. completion date: December 2000

Study information

• Verified date: December 2000
• 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 primary aim was to measure the effect of green tea extract, tyrosine and caffeine on energy expenditure, appetite ratings and spontaneous energy intake together with recording of side effects in healthy normal weight subjects.

Description:

Background: Long-term weight maintenance of a weight loss is often unsuccessful. Often a weight regain is observed in most studies that could indicate that most subjects are not able to change their eating habits. There is a need for simple and safe methods to prevent weight gain and re-gain i.e. by increasing thermogenesis and decrease spontaneous energy intake (EI). Studies have shown that nutritional and food-related non-nutritional factors influence the adjustment of EI and EE as the compounds can enhance the diet-induced thermogenesis (DIT) and suppress appetite.

Method: The present study was designed as a 4-way crossover, randomised, placebo controlled, dou-ble-blind study. Each treatment was separated by >3 d washout period. All treatments were administered as tablets containing either 500 mg green tea extract (whereof 125 mg cate-chins), 400 mg tyrosine, 50 mg anhydrous caffeine, or placebo.

on each test day body weight and composition was assessed. All participants underwent a 4.5-h assessment of energy expenditure by indirect calorimetry in a ventilated hood. Energy intake recorded of an ad libitum pasta salad brunch served after the last hood measurement

Subjects: Twelve healthy lean (20

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Twelve healthy and normal-weight men (age: 23.7?2.6 y, BMI: 22.4?1.8 kg/m2) participated in the study. They were weight stable (within 3-kg in last 3 mo), non-smoking, non-athletic, and had no use of dietary supplements or frequent use of medication.

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• tyrosine, green tea, caffeine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Science, Toxicology & Technology, San Francisco, California

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate
Primary	blood pressure
Primary	enegy expenditure
Primary	energy intake
Primary	subjective appetite sensations