UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000043913 |
|---|---|
| Receipt number | R000050103 |
| Scientific Title | Validation research on body-temperature regulation by test-food intakes |
| Date of disclosure of the study information | 2022/04/15 |
| Last modified on | 2022/04/11 13:14:57 |
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Basic information
Public title
Validation research on body-temperature regulation by test-food intakes
Acronym
Validation research on body-temperature regulation by test-food intakes
Scientific Title
Validation research on body-temperature regulation by test-food intakes
Scientific Title:Acronym
Validation research on body-temperature regulation by test-food intakes
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of improvement effect in body-temperature regulation by ingesting the test food to the subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changing rate of core-body temperature (drum temperature)
Key secondary outcomes
1. Body weight-changing rate
2. Plasma volume-changing rate
3. Total protein
4. Albumin
5. Serum sodium
6. Serum osmolality
7. Fractional excretion of sodium
8. Creatinine clearance
9. Free water clearance
10. Voided volume
11. Bloodstream (OMEGAZONE)
12. Heartbeat rate (Polar Unite)
13. Subjective symptoms based on a visual analog scale questionnaire (feebleness, thirst, hotness)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Freely consumption of the test/placebo food (two bottles a day) to the subject for five days at home.
Interventions/Control_2
On admission, consumption of the test/placebo food (two bottles a day) to the subject at the appointed time.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy male subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2.
(3) Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who have any difficulty in doing exercises with a bicycle ergometer for approximately 30 min.
(2) Subjects falling into the habit of excessive alcohol intake.
(3) Subjects who have the habit of smoking, at the present time and/or within a year before this trial.
(4) Subjects with extremely irregular life rhythm.
(5) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(6) Subjects being under some kind of continuous medical treatment, and/or planning to have it during this trial.
(7) Subjects having drug and/or food allergy.
(8) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within four weeks before this trial, or will join those after giving informed consent to participate in this trial.
(9) Subjects who donated 400 mL of their whole blood within the last three months before this trial.
(10) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Kato |
Organization
Toyo University
Division name
Professor, Director of the center
Zip code
350-0815
Address
2100 Kujirai, Kawagoe, Saitama 350-0815, Japan
TEL
049-239-1397
k-kato@toyo.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2022 | Year | 04 | 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
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 | 03 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 11 | 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 | 04 | Month | 13 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050103
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