NCT01294995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 cardiovascular-diseases

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_1 cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

February 14, 2011

Status Verified

October 1, 2010

Enrollment Period

1 month

First QC Date

February 11, 2011

Last Update Submit

February 11, 2011

Conditions

Keywords

short term consumptionChinese liquorserum lipidsuric acidinflammation biomarkers

Study Arms (2)

Tea-flavor Liquor, taken with meal

EXPERIMENTAL

including 12 males and 11 females

Dietary Supplement: Tea-flavor Liquor

Guizhou Meijiao Liquor, taken with meal

PLACEBO COMPARATOR

including 11 males and 11 females

Dietary Supplement: Guizhou Meijiao Liquor

Interventions

Tea-flavor LiquorDIETARY_SUPPLEMENT

30 mL of Tea-flavor Liquor(45% alcohol content)

Tea-flavor Liquor, taken with meal
Guizhou Meijiao LiquorDIETARY_SUPPLEMENT

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

Guizhou Meijiao Liquor, taken with meal

Eligibility Criteria

Age23 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of food science and nutrition

Hangzhou, Zhejiang, 310029, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

October 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 14, 2011

Record last verified: 2010-10

Locations