UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035593
Receipt number R000040514
Scientific Title Effects of Shiikuwasa (Citrus depressa Hayata) juice Ingest drinks on Blood flow improvement effect and body temperature maintenance effect for research concerning
Date of disclosure of the study information 2019/01/28
Last modified on 2020/10/01 11:15:45

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Basic information

Public title

Effects of Shiikuwasa (Citrus depressa Hayata) juice Ingest drinks on Blood flow improvement effect and body temperature maintenance effect for research concerning

Acronym

Effects of Shiikuwasa (Citrus depressa Hayata) juice Ingest drinks on Blood flow improvement effect and body temperature maintenance effect for research concerning

Scientific Title

Effects of Shiikuwasa (Citrus depressa Hayata) juice Ingest drinks on Blood flow improvement effect and body temperature maintenance effect for research concerning

Scientific Title:Acronym

Effects of Shiikuwasa (Citrus depressa Hayata) juice Ingest drinks on Blood flow improvement effect and body temperature maintenance effect for research concerning

Region

Japan


Condition

Condition

N/A (Healthy adults)

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

[1]Skin surface temperature

Key secondary outcomes

[1]Peripheral blood flow


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test drink (200mL in a day; 1 week)

Interventions/Control_2

Oral intake of the placebo drink (200mL in a day; 1 week)

Interventions/Control_3


Interventions/Control_4


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


Not applicable

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

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sumio Kondo

Organization

Medicial Corporation Kenshokai

Division name

Fukushima Healthcare Center

Zip code


Address

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

TEL

06-6441-6848

Email

hirose@okinawa-tlo.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazunobu Hirose

Organization

Okinawa TLO Co., Ltd.

Division name

Not Division

Zip code


Address

University of the Ryukyus - Industry-academia-government collaboration building 3F

TEL

098-895-1701

Homepage URL


Email

hirose@okinawa-tlo.com


Sponsor or person

Institute

Medicial Corporation Kenshokai, Fukushima Healthcare Center

Institute

Department

Personal name



Funding Source

Organization

Okinawa TLO 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


Address


Tel


Email



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

2019 Year 01 Month 28 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 01 Month 08 Day

Date of IRB

2018 Year 12 Month 17 Day

Anticipated trial start date

2019 Year 01 Month 21 Day

Last follow-up date

2019 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 19 Day

Last modified on

2020 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040514


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name