UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036209 |
|---|---|
| Receipt number | 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 | 2021/05/31 13:41:36 |
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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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041251
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