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

This study has been completed.

Sponsor:

Collaborator:

Guizhou Meijiao Co., Ltd, China

Information provided by:

Zhejiang University

ClinicalTrials.gov Identifier:

NCT01264666

First received: December 21, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	December 21, 2010
Last Updated Date	December 21, 2010
Start Date ^ICMJE	May 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2010)	serum sample [ Time Frame: 4 hours ] [ Designated as safety issue: No ] blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.
Original Primary Outcome Measures ^ICMJE	Same as current
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	Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors
Official Title ^ICMJE	Phase I Study of Chinese Tea Flavor Liquor on Human Health
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Alcohols Cardiovascular Diseases
Intervention ^ICMJE	Dietary Supplement: Chinese tea flavor liquor 60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal. Dietary Supplement: Chinese Meijiao liquor Dietary Supplement: Water control
Study Arm (s)	Experimental: Chinese tea flavor liquor Intervention: Dietary Supplement: Chinese tea flavor liquor Placebo Comparator: Water Water combined with meal as control. Intervention: Dietary Supplement: Water control Placebo Comparator: Chinese Meijiao Liquor Intervention: Dietary Supplement: Chinese 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
Enrollment ^ICMJE	16
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: no CVD history or liver disease, healthy young men Exclusion Criteria: smokers
Gender	Male
Ages	20 Years to 30 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	NCT01264666
Other Study ID Numbers ^ICMJE	Acute Chinese liquor study
Has Data Monitoring Committee	Yes
Responsible Party	Jusheng Zheng, Department of food science of nutrition, Zhejiang University
Study Sponsor ^ICMJE	Zhejiang University
Collaborators ^ICMJE	Guizhou Meijiao Co., Ltd, China
Investigators ^ICMJE	Not Provided
Information Provided By	Zhejiang University
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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