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

December 21, 2010 updated by: Zhejiang University

Phase I Study of Chinese Tea Flavor Liquor on Human Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310029
        • Department of Food Science of Nutrition, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • no CVD history or liver disease, healthy young men

Exclusion Criteria:

  • smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum sample
Time Frame: 4 hours
blood samples were collected at 0,0.5,1,2,4 hours postprandially to get serum sample.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

Guizhou Meijiao Co., Ltd, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 21, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute Chinese liquor study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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