UMIN-CTR Clinical Trial

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
Institute	Medicial Corporation Kenshokai, Fukushima Healthcare Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044683