ObesityPhase 1NCT00302289
B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients
A Phase 1 study testing tyrosine, green tea, caffeine in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- tyrosine, green tea, caffeine
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2000to Dec 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Twelve healthy and normal-weight men (age: 23.72.6 y, BMI: 22.41.8 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, 1958
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- tyrosine, green tea, caffeine
- Keywords
- green tea, caffeine, tyrosine, energy expenditure, energy intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tyrosine, green tea, caffeineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
blood pressure
enegy expenditure
energy intake
subjective appetite sensations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJan 2000
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Science, Toxicology & Technology, San Francisco, California
- Investigators
- Astrup Arne, Prof, Principal investigator, Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302289
- Sponsor's protocol ID
- KF01-188/00
- Status last verified
- Dec 2000
- First submitted
- 13 Mar 2006
- Last updated
- 14 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B181: Stimulation of Thermogenesis by Bio-Active Food Ingredients
- ClinicalTrials.gov ID
- NCT00302289
- Acronym / sponsor ID
- KF01-188/00
- Conditions
- Obesity
- Keywords
- green tea, caffeine, tyrosine, energy expenditure, energy intake
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Science, Toxicology & Technology, San Francisco, California
- Study start
- Jan 2000
- Study completion
- Dec 2000
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Twelve healthy and normal-weight men (age: 23.72.6 y, BMI: 22.41.8 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tyrosine, green tea, caffeine | Drug | – |
Primary outcome
heart rate
blood pressure
enegy expenditure
energy intake
subjective appetite sensations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrup Arne, Prof principal investigator
Department of Human Nutrition, The Royal Veterinary and Agricultural University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tyrosine, green tea, caffeine in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2006.