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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036209
Receipt No. R000041251
Scientific Title Effects of consumption of the test food on body temperature of healthy Japanese subjects: A randomized double-blind placebo-controlled study
Date of disclosure of the study information 2019/03/15
Last modified on 2019/05/20

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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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 58
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 No longer recruiting
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
2019 Year 05 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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