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

• Sponsor: Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01264666
• Collaborator: Guizhou Meijiao Co., Ltd, China (Other)
• Enrollment: 16
• Location: 1
• Arms: 3
• Duration (Months): 1
• Patients Per Site Per Month: 15.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohols; Cardiovascular Diseases	Dietary Supplement: Chinese tea flavor liquor; Dietary Supplement: Chinese Meijiao liquor; Dietary Supplement: Water control	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase I Study of Chinese Tea Flavor Liquor on Human Health
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chinese tea flavor liquor	Dietary Supplement: Chinese tea flavor liquor; 60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.
Placebo Comparator: Water Water combined with meal as control.	Dietary Supplement: Water control
Placebo Comparator: Chinese Meijiao Liquor	Dietary Supplement: Chinese Meijiao liquor

Outcome Measures

Primary Outcome Measures

1. serum sample [4 hours]

   blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• no CVD history or liver disease, healthy young men

Exclusion Criteria:

• smokers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food Science of Nutrition, Zhejiang University	Hangzhou	Zhejiang	China	310029

Sponsors and Collaborators

• Zhejiang University
• Guizhou Meijiao Co., Ltd, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01264666
• Other Study ID Numbers: Acute Chinese liquor study
• First Posted: Dec 22, 2010
• Last Update Posted: Dec 22, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Chinese tea flavor liquor; postprandial; uric acid; high-sensitive C-reactive protein
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Dec 22, 2010