Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors

Cardiovascular Diseases Clinical Trial

— TFL  

Official title:

Phase I Study of Chinese Tea Flavor Liquor on Human Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264666
• Other study ID #: Acute Chinese liquor study
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2010
• Last updated: December 21, 2010
• Start date: May 2010
• Est. completion date: June 2010

Study information

• Verified date: May 2010
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Zhejiang University
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• no CVD history or liver disease, healthy young men

Exclusion Criteria:

• smokers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohols
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Chinese tea flavor liquor
60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.
• Chinese Meijiao liquor

• Water control

Locations

Country	Name	City	State
China	Department of Food Science of Nutrition, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang University	Guizhou Meijiao Co., Ltd, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum sample	blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.	4 hours	No