UMIN-CTR Clinical Trial

Basic information
Public title	A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Acronym	A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Scientific Title	A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Scientific Title:Acronym	A study for effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions in healthy adult female who are concerned about cold.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects on body surface temperature and feeling of "Ninnikushoga" intake under cool conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area under the curve of body surface temperature
Key secondary outcomes	Body surface temperature Autonomic function Subjective symptoms questionnaire

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food (single ingestion) - washing out (a day or more) - intake of placebo (single ingestion)
Interventions/Control_2	Intake of placebo (single ingestion) - washing out (a day or more) - intake of test food (single ingestion)
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	64 years-old >=
Gender	Female
Key inclusion criteria	(1)Healthy females from 20 to 64 years of age (2)Subjects who are aware of getting cold of fingers under air conditioner working (3)Subjects who live an ordered life (4)Subjects who drop body surface temperature under cool conditions on preliminary examination
Key exclusion criteria	(1)Subjects who have been diagnosed underlying disease accompanied with angiopathy (e.g. arteriosclerosis obliterans, arteritis obliterans, collagen disease and diabetes, etc.) (2)Subjects who constantly take medicines affecting the skin surface temperature(e.g. warfarin) (3)Subjects who eat food for specified health or health food affecting the skin surface temperature(e.g. healthy food including garlic or ginger) at least once a week (4)Subjects having food allergy (5)Subjects who are smokers or have smoked within the past 3 months (6)Subjects who have a scar affecting the skin surface temperature and autonomic function on fingers, palms, toes and insteps (7)Subjects who have worked shifts day and night or are planned to work shifts day and night from a month before obtaining the consent for this study to the date of the completion this study (8)Subjects who have gone abroad or are planned to go abroad from a month before obtaining the consent for this study to the date of the completion this study (9)Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (10)Subjects who intend to become pregnant or lactating during the study (11)Subjects having a disease requiring treatment or taking medicines (12)Subjects having a history of serious diseases (13)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14)Subjects who are not judged as healthy based on the results of clinical and physical examination on preliminary examination (15)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Nakasone
Organization	Kenkoukazoku Co., Ltd.
Division name	None
Zip code	892-0848
Address	10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL	099-223-5211
Email	yasushi.nakasone@kenkoukazoku.co.jp

Public contact
Name of contact person	1st name Yoshimi Middle name Last name Bansho
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	bansho189@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	Kenkoukazoku 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	080-2290-2544
Email	makabe295@eps.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	2021 Year 06 Month 13 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	2021 Year 06 Month 10 Day
Date of IRB	2021 Year 06 Month 10 Day
Anticipated trial start date	2021 Year 06 Month 14 Day
Last follow-up date	2021 Year 07 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 11 Day
Last modified on	2021 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050833