UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039180
Receipt number R000044683
Scientific Title A study to examine the effects of blood flow improvement and body temperature maintenance effects
Date of disclosure of the study information 2020/02/01
Last modified on 2020/07/18 09:03:37

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Basic information

Public title

A study to examine the effects of blood flow improvement and body temperature maintenance effects

Acronym

A study to examine the effects of blood flow improvement and body temperature maintenance effects

Scientific Title

A study to examine the effects of blood flow improvement and body temperature maintenance effects

Scientific Title:Acronym

A study to examine the effects of blood flow improvement and body temperature maintenance effects

Region

Japan


Condition

Condition

Healthy Individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify that maintaining body-temperature by improving the blood flow of those who are aware of the cold-constitution.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin surface temperature

Key secondary outcomes

Peripheral blood flow


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test Food A (Tea)

Interventions/Control_2

Oral intake of the test Food B (Extract)

Interventions/Control_3

Oral intake of the test Food C (Tablet)

Interventions/Control_4

Oral intake of the placebo

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

[1]Males and Females aged 20> years.
[2]Those who are conscious of coldness of 4 points or more (Important item; 2 point, Reference item 1 point) in coldness diagnosis questionnaire
[3] Those whose skin temperature recovery rate is less than 90% after 10 minutes of cold load in skin temperature recovery rate measurement
[4] Those who obtain consent from the document with free will of the subject

Key exclusion criteria

[1]Those who are at risk of developing allergy in connection with research
[2]Those who have been diagnosed as underlying diseases associated with vascular disorders (obstructive arteriosclerosis, obstructive arteritis, collagen disease, diabetes etc.)
[3]Those who were judged inappropriate as subjects from the answers to the questionnaire
[4]Those who have a smoking habit
[5]Those who regularly use prescribed medicines (eg, warfarin, etc.) that may affect blood flow and skin surface temperature
[6]Those who take foods for specified health use or health foods that affect blood flow and skin surface temperature for three days or more per week
[7]Those already taking citrus drinks such as shikuwasa and oranges more than 3 days a week
[8]Those who were judged to have problems with research participation due to abnormalities in clinical laboratory values or cardiorespiratory functions
[9]Those who have a disease requiring continuous medication, those who have had a serious medical history requiring medication therapy
[10]Persons whose values of physical measurement values, physical examination values and clinical laboratory values before the start of ingestion are significantly deviated from the reference range
[11]Those who participate in other clinical research at the start of this research
[12]Others who judged that the researcher is inappropriate as the subject

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Kondo
Middle name
Last name Sumio

Organization

Medicial Corporation Kenshokai

Division name

Fukushima Healthcare Center

Zip code

553-0004

Address

Tamagawa 2-12-16, Fukushima-ku, Osaka-shi, Osaka, 553-0004, Japan

TEL

06-6441-6848

Email

rtakeda@tamateyama.ac.jp


Public contact

Name of contact person

1st name Takeda
Middle name Takeda
Last name Ryuji

Organization

Kansai University of Welfare Sciences

Division name

Department of Nutritional Sciences for Well-being

Zip code

582-0026

Address

Asahigaoka 3-11-1, Kashiwara-cuty

TEL

072-978-0088

Homepage URL


Email

rtakeda@tamateyama.ac.jp


Sponsor or person

Institute

Medicial Corporation Kenshokai, Fukushima Healthcare Center

Institute

Department

Personal name



Funding Source

Organization

Musashino Rsearch Institute for Immunity Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Brain Care Clinic Ethics Review Committee

Address

Samon-Cho13, Isobe Build. 2F, Shinjyuku-ku, Tokyo

Tel

03-3351-3386

Email

yuyosei@drc-web.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 12 Month 13 Day

Date of IRB

2019 Year 12 Month 20 Day

Anticipated trial start date

2020 Year 01 Month 18 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry

2020 Year 07 Month 18 Day

Date trial data considered complete

2020 Year 07 Month 31 Day

Date analysis concluded

2020 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 01 Month 17 Day

Last modified on

2020 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044683


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name