Effect of Short-term Chinese Tea-flavor Liquor Consumption
ESTCTFLC
Phase 1 Study of Chinese Tea-flavor Liquor
1 other identifier
interventional
45
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 cardiovascular-diseases
Started Oct 2010
Shorter than P25 for phase_1 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedFebruary 14, 2011
October 1, 2010
1 month
February 11, 2011
February 11, 2011
Conditions
Keywords
Study Arms (2)
Tea-flavor Liquor, taken with meal
EXPERIMENTALincluding 12 males and 11 females
Guizhou Meijiao Liquor, taken with meal
PLACEBO COMPARATORincluding 11 males and 11 females
Interventions
30 mL of Tea-flavor Liquor(45% alcohol content)
30 mL of Guizhou Meijiao Liquor (45% alcohol content)
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteers
You may not qualify if:
- Subjects with a history of liver disease, diabetes, or heart disease
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- Guizhou Meijiao Co., Ltdcollaborator
Study Sites (1)
Department of food science and nutrition
Hangzhou, Zhejiang, 310029, China
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
October 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 14, 2011
Record last verified: 2010-10