Effect of Short-term Chinese Tea-flavor Liquor Consumption (ESTCTFLC)

This study has been completed.

Sponsor:

Collaborator:

Guizhou Meijiao Co., Ltd

Information provided by:

Zhejiang University

ClinicalTrials.gov Identifier:

NCT01294995

First received: February 11, 2011

Last updated: NA

Last verified: October 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 11, 2011
Last Updated Date	February 11, 2011
Start Date ^ICMJE	October 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Short-term Chinese Tea-flavor Liquor Consumption
Official Title ^ICMJE	Phase 1 Study of Chinese Tea-flavor Liquor
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cardiovascular Diseases
Intervention ^ICMJE	Dietary Supplement: Tea-flavor Liquor 30 mL of Tea-flavor Liquor(45% alcohol content) Dietary Supplement: Guizhou Meijiao Liquor 30 mL of Guizhou Meijiao Liquor (45% alcohol content)
Study Arm (s)	Experimental: Tea-flavor Liquor, taken with meal including 12 males and 11 females Intervention: Dietary Supplement: Tea-flavor Liquor Placebo Comparator: Guizhou Meijiao Liquor, taken with meal including 11 males and 11 females Intervention: Dietary Supplement: Guizhou Meijiao Liquor
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	45
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy male and female volunteers Exclusion Criteria: Subjects with a history of liver disease, diabetes, or heart disease Smokers
Gender	Both
Ages	23 Years to 28 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01294995
Other Study ID Numbers ^ICMJE	ST Chinese liquor study
Has Data Monitoring Committee	Yes
Responsible Party	Department of Food Science and Nutrition
Study Sponsor ^ICMJE	Zhejiang University
Collaborators ^ICMJE	Guizhou Meijiao Co., Ltd
Investigators ^ICMJE	Not Provided
Information Provided By	Zhejiang University
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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