Cardiovascular DiseasesPhase 1ESTCTFLCNCT01294995
Effect of Short-term Chinese Tea-flavor Liquor Consumption
A Phase 1 study testing Tea-flavor Liquor and Guizhou Meijiao Liquor in people with Cardiovascular Diseases, run by Zhejiang University at 1 site in China.
Trial summary
Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and CVD risk factors. Read more about this study
- Who is it for?
- Ages 23 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Tea-flavor Liquor and Guizhou Meijiao Liquor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Nov 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 23 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers
Who cannot join
- Subjects with a history of liver disease, diabetes, or heart disease
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Chinese Tea-flavor Liquor
Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor fermented from above 5 grains plus green tea.
Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids, inflammation biomarkers and CVD risk factors.
Read more
TFL could significantly decrease systolic blood pressure of males, but increase diastolic blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for females. Both liquor significantly decrease serum uric acid and glucose in males and females. The effect of the two liquors on inflammation biomarkers were complicated and needs further research work.
TFL may possess more beneficial effect on CVD risk factors than GML probably because of the special fermentation products of green tea with other grains.
- Conditions
- Cardiovascular Diseases
- Being tested
- Tea-flavor Liquor, Guizhou Meijiao Liquor
- Keywords
- short term consumption, Chinese liquor, serum lipids, uric acid, inflammation biomarkers
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tea-flavor LiquorDietary supplement
30 mL of Tea-flavor Liquor(45% alcohol content)
Guizhou Meijiao LiquorDietary supplement
30 mL of Guizhou Meijiao Liquor (45% alcohol content)
| Study group | Role | What they receive |
|---|---|---|
| Tea-flavor Liquor, taken with meal | Experimental | including 12 males and 11 females Receives: Dietary Supplement: Tea-flavor Liquor |
| Guizhou Meijiao Liquor, taken with meal | Placebo comparator | including 11 males and 11 females Receives: Dietary Supplement: Guizhou Meijiao Liquor |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Guizhou Meijiao Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294995
- Sponsor's protocol ID
- ST Chinese liquor study
- Acronym
- ESTCTFLC
- Status last verified
- Oct 2010
- First submitted
- 11 Feb 2011
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Chinese Tea-flavor Liquor
- ClinicalTrials.gov ID
- NCT01294995
- Acronym / sponsor ID
- ESTCTFLC / ST Chinese liquor study
- Conditions
- Cardiovascular Diseases
- Keywords
- short term consumption, Chinese liquor, serum lipids, uric acid, inflammation biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Guizhou Meijiao Co., Ltd
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Feb 2011 (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.
Human studies of Chinese liquor are sparse. The investigators hypothesize that short-term Chinese Tea-flavor liquor (TFL) consumption may be beneficial to inflammation biomarkers and CVD risk factors. Guizhou Meijiao Liquor (GML) is a traditional Chinese liquor, fermented from sorghum, corn, sticky rice, wheat and rice, while TFL is a novel Chinese liquor fermented from above 5 grains plus green tea.
Forty-five volunteers(23 males, 22 females) were selected to participate a paralleled randomized trial drinking 30 mL two kinds of Chinese liquors: TFL and GML respectively with meal every day for 28 days. Serums of volunteers were collected for analyzing serum lipids, inflammation biomarkers and CVD risk factors.
TFL could significantly decrease systolic blood pressure of males, but increase diastolic blood pressure of females. TFL could also decreased blood lipid of volunteers, especially for females. Both liquor significantly decrease serum uric acid and glucose in males and females. The effect of the two liquors on inflammation biomarkers were complicated and needs further research work.
TFL may possess more beneficial effect on CVD risk factors than GML probably because of the special fermentation products of green tea with other grains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tea-flavor Liquor, taken with meal | Experimental | Dietary Supplement: Tea-flavor Liquorincluding 12 males and 11 females |
| Guizhou Meijiao Liquor, taken with meal | Placebo comparator | Dietary Supplement: Guizhou Meijiao Liquorincluding 11 males and 11 females |
Who may qualify
- Ages
- 23 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female volunteers
Key exclusion criteria (2 listed)
- Subjects with a history of liver disease, diabetes, or heart disease
- 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 |
|---|---|---|
| Tea-flavor Liquor30 mL of Tea-flavor Liquor(45% alcohol content) | Dietary supplement | Tea-flavor Liquor, taken with meal |
| Guizhou Meijiao Liquor30 mL of Guizhou Meijiao Liquor (45% alcohol content) | Dietary supplement | Guizhou Meijiao Liquor, taken with meal |
Primary outcome
Not reported in the source record.
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 Feb 2011.
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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 Tea-flavor Liquor and Guizhou Meijiao Liquor in people with 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 2 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 Feb 2011. 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.
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 Feb 2011.