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

NCT02079571 | Unknown

• 1 other identifier: 201301076RINB
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects With Different Constitutions

Outcome Measures

Primary Outcomes (1)

• Determinations of pulse waves and channel entries produced in healthy subjects with different constitutions by a Smart Pulse Wave Health Evaluation System

  three hours after each intervention

Study Arms (2)

water+ Coconut water

EXPERIMENTAL

forty subjects

Dietary Supplement: Coconut water

ginger tea +water

EXPERIMENTAL

Dietary Supplement: ginger tea

Interventions

Coconut water DIETARY_SUPPLEMENT

250 ml Coconut water for each subject

water+ Coconut water

ginger tea DIETARY_SUPPLEMENT

250 ml for each subject

ginger tea +water

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult over twenty years old

You may not qualify if:

• Severe hypertension
• Cardiovascular diseases

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Kuan-Hung Lu

Taipei, 106, Taiwan

RECRUITING

Study Officials

• Ming-Shiang Wu, MD, Ph D

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

  STUDY CHAIR

Central Study Contacts

Lee-Yan Sheen, Ph.D.

CONTACT

+886-2-33664130; lysheen@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: March 6, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: March 6, 2014

Record last verified: 2014-03

Locations

TW (1)