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B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302289
First Posted: March 14, 2006
Last Update Posted: March 14, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Science, Toxicology & Technology, San Francisco, California
Information provided by:
University of Copenhagen
  Purpose
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.

Condition Intervention Phase
Obesity Drug: tyrosine, green tea, caffeine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • heart rate
  • blood pressure
  • enegy expenditure
  • energy intake
  • subjective appetite sensations

Estimated Enrollment: 12
Study Start Date: January 2000
Estimated Study Completion Date: December 2000
Detailed 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<BMI<25) weight stable non-smoking subjects between 18-40 years of age were tested 4 times each with a wash-out period of at least 3 days.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302289


Locations
Denmark
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Science, Toxicology & Technology, San Francisco, California
Investigators
Principal Investigator: Astrup Arne, Prof Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00302289     History of Changes
Other Study ID Numbers: KF01-188/00
First Submitted: March 13, 2006
First Posted: March 14, 2006
Last Update Posted: March 14, 2006
Last Verified: December 2000

Keywords provided by University of Copenhagen:
green tea
caffeine
tyrosine
energy expenditure
energy intake

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents