AlcoholsPhase 1TFLNCT01264666
Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors
A Phase 1 study testing Chinese tea flavor liquor and Chinese Meijiao liquor in people with Alcohols and Cardiovascular Diseases, run by Zhejiang University at 1 site in China.
Trial summary
Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially. Design: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohols, Cardiovascular Diseases
- What is being tested?
- Chinese tea flavor liquor and Chinese Meijiao liquor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jun 2010
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no CVD history or liver disease, healthy young men
Who cannot join
- smokers
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Food Science of Nutrition, Zhejiang University
Hangzhou, Zhejiang, 310029
About this study
Official title: Phase I Study of Chinese Tea Flavor Liquor on Human Health
Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially.
Design: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45% alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours postprandially.
Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.
- Conditions
- Alcohols, Cardiovascular Diseases
- Being tested
- Chinese tea flavor liquor, Chinese Meijiao liquor, Water control
- Keywords
- Chinese tea flavor liquor, postprandial, uric acid, high-sensitive C-reactive protein
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese tea flavor liquorDietary supplement
60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.
Chinese Meijiao liquorDietary supplement
Water controlDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Chinese tea flavor liquor | Experimental | Not described Receives: Dietary Supplement: Chinese tea flavor liquor |
| Water | Placebo comparator | Water combined with meal as control. Receives: Dietary Supplement: Water control |
| Chinese Meijiao Liquor | Placebo comparator | Not described Receives: Dietary Supplement: Chinese Meijiao liquor |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum sample
blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Guizhou Meijiao Co., Ltd, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264666
- Sponsor's protocol ID
- Acute Chinese liquor study
- Acronym
- TFL
- Status last verified
- May 2010
- First submitted
- 21 Dec 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Chinese Tea Flavor Liquor on Human Health
- ClinicalTrials.gov ID
- NCT01264666
- Acronym / sponsor ID
- TFL / Acute Chinese liquor study
- Conditions
- Alcohols, Cardiovascular Diseases
- Keywords
- Chinese tea flavor liquor, postprandial, uric acid, high-sensitive C-reactive protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Guizhou Meijiao Co., Ltd, China
- Study start
- May 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Dec 2010 (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.
Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially.
Design: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45% alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours postprandially.
Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chinese tea flavor liquor | Experimental | Dietary Supplement: Chinese tea flavor liquor |
| Water | Placebo comparator | Dietary Supplement: Water controlWater combined with meal as control. |
| Chinese Meijiao Liquor | Placebo comparator | Dietary Supplement: Chinese Meijiao liquor |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- no CVD history or liver disease, healthy young men
Key exclusion criteria (1 listed)
- smokers
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 |
|---|---|---|
| Chinese tea flavor liquor60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal. | Dietary supplement | Chinese tea flavor liquor |
| Chinese Meijiao liquor | Dietary supplement | Chinese Meijiao Liquor |
| Water control | Dietary supplement | Water |
Primary outcome
serum sample
Time frame: 4 hours
blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.
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 22 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chinese tea flavor liquor and Chinese Meijiao liquor in people with Alcohols and Cardiovascular Diseases, run by Zhejiang University at 1 site in China.
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 22 Dec 2010. 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 China. 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. Some participants in this study may receive a placebo. 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?
serum sample (time frame: 4 hours). 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 22 Dec 2010.