UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy of test food on blood flow improvement
Acronym	Evaluation of the efficacy of test food on blood flow improvement
Scientific Title	Evaluation of the efficacy of test food on blood flow improvement
Scientific Title:Acronym	Evaluation of the efficacy of test food on blood flow improvement
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of single-consumption of the test food on blood flow improvement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood flow
Key secondary outcomes	Skin surface temperature Core body temperature VAS for feeling of cold

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Taking a placebo food -> Washout period for over 1 week -> Taking a test food 1 -> Washout period for over 1 week -> Taking a test food 2
Interventions/Control_2	Taking a test food 1 -> Washout period for over 1 week -> Taking a test food 2 -> Washout period for over 1 week -> Taking a placebo food
Interventions/Control_3	Taking a test food 2 -> Washout period for over 1 week -> Taking a placebo food -> Washout period for over 1 week -> Taking a test food 1
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females from 20 to 64 years old. 2) Subjects who are sensitive to cold. 3) Subjects whose written informed consent has been obtained.
Key exclusion criteria	1) Subjects who were diagnosed as oversensitiveness to cold by medical doctor. 2) Subjects who are undergoing some kind of drug treatment. 3) Subjects who constantly use oral medicines, functional foods or supplements which improve fatigue, blood flow, coldness or stress. 4) Females who are pregnant or lactating, and who could become pregnant during test period. 5) Subjects who have current or previous medical history of serious disease. 6) Subjects who consume excessive alcohol. 7) Smoker. 8) Subjects who have extremely irregular habits of dining, and who have irregular lifestyle rhythms. 9) Subjects who have allergy to drug or food. 10) Subjects who have cold allergy. 11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study or who plan to participate the other clinical tests. 12) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Shukuko Middle name Last name Ebihara
Organization	Chiyoda Paramedical Care Clinic
Division name	Director
Zip code	101-0047
Address	2F Sanwauchikanda Building , 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
TEL	03-5297-5548
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Mitsuhiro Middle name Last name Fujimoto
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Sanwauchikanda Building , 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	KOBAYASHI Pharmaceutical 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2019 Year 10 Month 20 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 09 Month 24 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 10 Month 21 Day
Last follow-up date	2019 Year 12 Month 03 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 10 Month 09 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043583