UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on body temperature of healthy Japanese subjects
Acronym	Effects of consumption of the test food on body temperature of healthy Japanese subjects
Scientific Title	Effects of consumption of the test food on body temperature of healthy Japanese subjects: A randomized double-blind placebo-controlled study
Scientific Title:Acronym	Effects of consumption of the test food on body temperature of healthy Japanese subjects
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food on body temperature of healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Basal body temperature on awakening * Measure daily body temperature on awakening from 1 week before screening (before consumption) * Measure daily body temperature on awakening from the start consumption to the day before 4-week examination. * Assess the average body temperature on awakening per week.
Key secondary outcomes	1. Palmar Skin Temperature 2. Subjective symptoms (the Likert scale) * Measure the values before and after cold water load at screening (before consumption) and 4 weeks after consumption and calculate the amount of change.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Test food: Allium victorialis subsp. platyphyllum extracts capsule Administration: Take 2 capsules with water after breakfast without chewing. *If you feel your body gets too warm when taking 2 capsules once a day, change to the following administration. Take 1 capsule with water after breakfast and lunch without chewing (take a capsule twice a day). * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 4 weeks Test food: Placebo capsule Administration: Take 2 capsules with water after breakfast without chewing. *If you feel your body gets too warm when taking 2 capsules once a day, change to the following administration. Take 1 capsule with water after breakfast and lunch without chewing (take a capsule twice a day). * If you forget to take the test food, take it as soon as you remember within the day.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy subjects 2. Subjects who are older than 40 years 3. Subjects whose basal body temperature on awakening is 35.6 degrees celsius or more and less than 36.5 degrees celsius 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who have relatively low basal body temperature on awakening at 1 week before screening (before consumption) 6. Subjects who showed relatively small AUC of palmar skin temperature before and after cold water load at screening (before consumption)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, and sinus tachycardia. 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypothyroidism, or any other chronic diseases. 4. Subjects who are undergoing medical treatment of blood disorders. 5. Subjects who are undergoing medical treatment of anemia. 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 7. Subjects who are currently taking medications (including herbal medicines) and supplements. 8. Subjects who drink alcoholic beverages to excess {Average amount of alcohol intake is approximately 60 g per day converted into absolute alcohol (approximately 540 mL of Japanese sake, 3 cans (500 mL/can) of beer, or 300 mL of distilled spirits)} 9. Subjects who cannot immerse their hands in water during the cold season (Those who change their fingertips purple or white when they are immersed in water). 10. Subjects who are allergic to medicines and/or the test food related products. 11. Subjects who are pregnant, lactation, or planning to become pregnant. 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period. 13. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	YASOUKOUSO .Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 15 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/48020/243
Number of participants that the trial has enrolled	58
Results	Kanai T, Suzuki N, Yamashita S, Morimoto Y, Takara T. Verification of the Effects of Capsules Containing Allium victorialis subsp. platyphyllum Extract on the Body Temperature of Healthy Japanese Adults-A Randomized, Double-blind, Placebo-controlled Clinical Trial-. Jpn Pharmacol Ther. 2020; 48(2): 243-257.
Results date posted	2021 Year 05 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 02 Month 27 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 03 Month 11 Day
Date of IRB	2019 Year 03 Month 11 Day
Anticipated trial start date	2019 Year 03 Month 16 Day
Last follow-up date	2019 Year 07 Month 10 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 03 Month 15 Day
Last modified on	2021 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041251