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ESTCTFLC: Effect of Short-term Chinese Tea-flavor Liquor Consumption

Sponsor
Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT01294995
Collaborator
Guizhou Meijiao Co., Ltd (Other)
45
Enrollment
1
Location
2
Arms
1
Duration (Months)
44.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Tea-flavor Liquor
  • Dietary Supplement: Guizhou Meijiao Liquor
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Study of Chinese Tea-flavor Liquor
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tea-flavor Liquor, taken with meal

including 12 males and 11 females

Dietary Supplement: Tea-flavor Liquor
30 mL of Tea-flavor Liquor(45% alcohol content)
Placebo Comparator: Guizhou Meijiao Liquor, taken with meal

including 11 males and 11 females

Dietary Supplement: Guizhou Meijiao Liquor
30 mL of Guizhou Meijiao Liquor (45% alcohol content)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Years to 28 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy male and female volunteers
    Exclusion Criteria:

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

    • Smokers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of food science and nutrition Hangzhou Zhejiang China 310029

    Sponsors and Collaborators

    • Zhejiang University
    • Guizhou Meijiao Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01294995
    Other Study ID Numbers:
    • ST Chinese liquor study
    First Posted:
    Feb 14, 2011
    Last Update Posted:
    Feb 14, 2011
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    short term consumption
    Chinese liquor
    serum lipids
    uric acid
    inflammation biomarkers
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Feb 14, 2011