Investigation of Pulse Waves, Channel Entries, and Food Attributes in Healthy Subjects With Different Constitutions

NCT ID: NCT02079571

Last Updated: 2014-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Brief Summary

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In traditional Chinese medicine (TCM), hot- and cold-attribute of food ingredients are a major part of dietary therapy. "Eight Principles" including cold/hot, repletion/vacuity, yin/yang and exterior/interior are used for diagnose by Chinese medical doctors. From the perspective of TCM, all constitutions, diseases, herbal medicine and foods can be divided into these two major categories, i.e., cold and hot. Therefore, dietary therapy claims that the attributes of foods should be used to oppose our constitutions in order to harmonize organ functions and maintain human vitality. The true benefit of dietary therapy is considered to be the reestablishment of a harmonious balance between cold and hot, or repletion and vacuity, within the human body.

Previous studies reported that the capillary red blood cell (RBC) velocity in nail fold microcirculation (NFM) of the subjects with hot constitution accelerated significantly after taking the hot attribute aged ginger tea, which might be the result of elevated vagal activity leading to arteriole dilation in these subjects. In contrast, in subjects with cold constitution, capillary RBC velocity decelerated significantly and skin temperature decreased markedly after taking the cold-attribute coconut water, which might have been induced by sympathetic nerve activation causing the arteriole to be constricted. As a result, the use of capillary RBC velocity of NFM measured by laser Doppler anemometer may be a promising way to classify attributes of food ingredients commonly used in Chinese medicine dietary therapy in accordance with different personal constitutions.

Accordingly, it will be a worthwhile task to establish a modern scientific methodology to define the attributes of food ingredients. The aim of this project is to investigate the relationship between food attributes and the physiological signals produced in healthy young subjects with different constitutions. In the first year of this project, investigators are starting to determine the pulse waves produced in healthy subjects with different constitutions by a Smart Pulse Wave Health Evaluation System (S-PULSE). Then, investigators will investigate the relationship between food attributes, channel entries and the physiological signals. Hopefully, the results will have a leverage on the powerful integration capacity within National Taiwan University (NTU) campus to build a hub for global TCM cloud.

Detailed Description

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Conditions

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Healthy Subjects With Different Constitutions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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water+ Coconut water

forty subjects

Group Type EXPERIMENTAL

Coconut water

Intervention Type DIETARY_SUPPLEMENT

250 ml Coconut water for each subject

ginger tea +water

Group Type EXPERIMENTAL

ginger tea

Intervention Type DIETARY_SUPPLEMENT

250 ml for each subject

Interventions

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Coconut water

250 ml Coconut water for each subject

Intervention Type DIETARY_SUPPLEMENT

ginger tea

250 ml for each subject

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy adult over twenty years old

Exclusion Criteria

* Severe hypertension
* Cardiovascular diseases
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Shiang Wu, MD, Ph D

Role: STUDY_CHAIR

Chairman and Professor of Primary Care Medicine, College of Medicine, National Taiwan University Hospital

Locations

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Kuan-Hung Lu

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Lee-Yan Sheen, Ph.D.

Role: CONTACT

+886-2-33664130

Facility Contacts

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Kuan-Hung Lu, Ph.D.

Role: primary

+886-2-33664130

Other Identifiers

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201301076RINB

Identifier Type: -

Identifier Source: org_study_id

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