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B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

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ClinicalTrials.gov Identifier: NCT00302289
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : March 14, 2006
Science, Toxicology & Technology, San Francisco, California
Information provided by:
University of Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: tyrosine, green tea, caffeine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients
Study Start Date : January 2000
Estimated Study Completion Date : December 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
Drug Information available for: Tyrosine
U.S. FDA Resources

Primary Outcome Measures :
  1. heart rate
  2. blood pressure
  3. enegy expenditure
  4. energy intake
  5. subjective appetite sensations

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

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:

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

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
Principal Investigator: Astrup Arne, Prof Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark

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

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

Additional relevant MeSH terms:
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