B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients

NCT ID: NCT00302289

Last Updated: 2006-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2000-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tyrosine, green tea, caffeine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Science, Toxicology & Technology, San Francisco, California

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Astrup Arne, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KF01-188/00

Identifier Type: -

Identifier Source: org_study_id