Effect of Short-term Chinese Tea-flavor Liquor Consumption

Cardiovascular Diseases Clinical Trial

— ESTCTFLC  

Official title:

Phase 1 Study of Chinese Tea-flavor Liquor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294995
• Other study ID #: ST Chinese liquor study
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2011
• Last updated: February 11, 2011
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: October 2010
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Department of Food Science and Nutrition
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 28 Years

Eligibility

Inclusion Criteria:

• Healthy male and female volunteers

Exclusion Criteria:

• Subjects with a history of liver disease, diabetes, or heart disease

• Smokers

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Tea-flavor Liquor
30 mL of Tea-flavor Liquor(45% alcohol content)
• Guizhou Meijiao Liquor
30 mL of Guizhou Meijiao Liquor (45% alcohol content)

Locations

Country	Name	City	State
China	Department of food science and nutrition	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Guizhou Meijiao Co., Ltd

Country where clinical trial is conducted

China,