Effect of Short-term Chinese Tea-flavor Liquor Consumption (ESTCTFLC)

February 11, 2011 updated by: Zhejiang University

Phase 1 Study of Chinese Tea-flavor Liquor

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.

Study Overview

Status

Status

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Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

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Interventional

Enrollment (Anticipated)

Enrollment

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45

Phase

Phase

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  • Phase 1

Contacts and Locations

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Study Locations

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

Participation Criteria

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Eligibility Criteria

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Ages Eligible for Study

23 years to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female volunteers

Exclusion Criteria:

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

Study Plan

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How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

Collaborators and Investigators

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Sponsor

Sponsor

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Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guizhou Meijiao Co., Ltd

Study record dates

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Study Major Dates

Study Start

Study Start

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October 1, 2010

Primary Completion (Actual)

Primary Completion

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November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST Chinese liquor study

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