UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052683 |
|---|---|
| Receipt number | R000060025 |
| Scientific Title | Effects of consumption of the test food on body temperature and blood flow: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/11/02 |
| Last modified on | 2024/05/24 17:29:22 |
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Basic information
Public title
Effects of consumption of the test food on body temperature and blood flow
Acronym
Effects of consumption of the test food on body temperature and blood flow
Scientific Title
Effects of consumption of the test food on body temperature and blood flow: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on body temperature and blood flow
Region
| Japan |
Condition
Condition
Healthy Japanese
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 and blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
<Evaluation after continuous intake for four weeks>
1. The area under the curve (AUC) of the right palmar skin surface temperature from immediately to 60 minutes after cold water load at examination four weeks after consumption (4w)
Key secondary outcomes
<Evaluation after continuous intake for four weeks>
1. The AUC of the left palmar skin surface blood flow from immediately to 60 minutes after cold water load at 4w
2. The measured values of the right palmar skin surface temperature at each measurement point, and the changes from measurements before and immediately after cold water load at 4w
3. The measured values of the left palmar skin surface blood flow at each measurement point, and the changes from measurements before and immediately after cold water load at 4w
4. The measured value of each item in the original questionnaire about cold hands and body at each measurement point at 4w
5. The measured value of each item in the original questionnaire on physical condition at 4w
6. The measured values of blood flow velocity, blood vessel diameter, renin activity, three fractions of catecholamine, asymmetric dimethylarginine (ADMA), nitrogen oxide (NOx), and heat shock protein at 4w
<Evaluation by single intake>
1. The AUC of the right palmar skin surface temperature from immediately to 60 minutes after cold water load at examination after consumption
2. The AUC of the left palmar skin surface blood flow from immediately to 60 minutes after cold water load at examination after consumption
3. The measured values of the right palmar skin surface temperature at each measurement point, and the changes from measurements before cold water load at examination after consumption
4. The measured values of the left palmar skin surface blood flow at each measurement point, and the changes from measurements before cold water load at examination after consumption
5. The measured value of each item in the original questionnaire about cold hands and body at each measurement point at examination after consumption
6. The measured values of blood flow velocity, blood vessel diameter, renin activity, three fractions of catecholamine, ADMA, NOx, and heat shock protein at examination after consumption
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: Four weeks
Test food: Active food
Interventions/Control_2
Duration: Four weeks
Test food: Placebo food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals whose body weight is 40 kg or more
6. Individuals who are concerned about coldness of their hands and feet
7. Individuals whose the AUC of the right palmar skin surface temperature from immediately after cold water load is low among those meeting No.1~6 of the inclusion criteria and not meeting the exclusion criteria
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are undergoing medical treatment for anemia or cold sensitivity
5. Individuals who cannot use water in the cold season (whose fingertips change color to purple or white when these hands are put in water)
6. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
7. Individuals who are taking food/beverage with functional ingredients which may affect thermoregulation (e.g., monoglucosyl hesperidin, polyphenols from ginger, 6-gingerol, 6-shogaol, piperines from Piper longum, ellagic acid, L-citrulline, flavonoid from Crataegus laevigata, hyperin, capsaicin, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or camelliasaponin B2)
8. Individuals who are taking medications (including herbal medicines) and supplements
9. Individuals who are allergic to medicines and/or the test food related products
10. Individuals who are pregnant, lactating, or planning to become pregnant during this study
11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
12. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
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
Mizkan Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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 Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 02 | 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
44
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
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060025
