NCT01264666

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1

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

May 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
Last Updated

December 22, 2010

Status Verified

May 1, 2010

Enrollment Period

1 month

First QC Date

December 21, 2010

Last Update Submit

December 21, 2010

Conditions

AlcoholsCardiovascular Diseases

Keywords

Chinese tea flavor liquorpostprandialuric acidhigh-sensitive C-reactive protein

Outcome Measures

Primary Outcomes (1)

  • serum sample

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

    4 hours

Study Arms (3)

Chinese tea flavor liquor

EXPERIMENTAL
Dietary Supplement: Chinese tea flavor liquor

Water

PLACEBO COMPARATOR

Water combined with meal as control.

Dietary Supplement: Water control

Chinese Meijiao Liquor

PLACEBO COMPARATOR
Dietary Supplement: Chinese Meijiao liquor

Interventions

Chinese tea flavor liquorDIETARY_SUPPLEMENT

60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.

Chinese tea flavor liquor
Chinese Meijiao liquorDIETARY_SUPPLEMENT
Chinese Meijiao Liquor
Water controlDIETARY_SUPPLEMENT
Water

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no CVD history or liver disease, healthy young men

You may not qualify if:

  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science of Nutrition, Zhejiang University

Hangzhou, Zhejiang, 310029, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 22, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 22, 2010

Record last verified: 2010-05

Locations

CN(1)