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

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ClinicalTrials.gov Identifier: NCT02079571
Recruitment Status : Unknown
Verified March 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Subjects With Different Constitutions Dietary Supplement: Coconut water Dietary Supplement: ginger tea Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Pulse Waves and Channel Entries Produced in Healthy Subjects With Different Constitutions and Their Changes After Treated With Foods of Different Food Attributes
Study Start Date : May 2013
Estimated Primary Completion Date : December 2014

Arm Intervention/treatment
Experimental: water+ Coconut water
forty subjects
Dietary Supplement: Coconut water
250 ml Coconut water for each subject

Experimental: ginger tea +water Dietary Supplement: ginger tea
250 ml for each subject




Primary Outcome Measures :
  1. Determinations of pulse waves and channel entries produced in healthy subjects with different constitutions by a Smart Pulse Wave Health Evaluation System [ Time Frame: three hours after each intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult over twenty years old

Exclusion Criteria:

  • Severe hypertension
  • Cardiovascular diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079571


Contacts
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Contact: Lee-Yan Sheen, Ph.D. +886-2-33664130 lysheen@ntu.edu.tw

Locations
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Taiwan
Kuan-Hung Lu Recruiting
Taipei, Taiwan, 106
Contact: Kuan-Hung Lu, Ph.D.    +886-2-33664130    a062016@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Ming-Shiang Wu, MD, Ph D Chairman and Professor of Primary Care Medicine, College of Medicine, National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02079571     History of Changes
Other Study ID Numbers: 201301076RINB
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014