UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053309 |
|---|---|
| Receipt number | R000060850 |
| Scientific Title | The effect of the test diet on the absorption and excretion of water and electrolytes in the body in a heatstroke dehydration model - A randomized, double-blind, placebo-controlled, two-periods cross-over comparative trial - |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/05/21 14:19:51 |
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Basic information
Public title
The effect of the test diet on the absorption and excretion of water and electrolytes in the body under a heatstroke dehydration model
Acronym
The effect of the test diet on the absorption and excretion of water and electrolytes in the body under a heatstroke dehydration model
Scientific Title
The effect of the test diet on the absorption and excretion of water and electrolytes in the body in a heatstroke dehydration model
- A randomized, double-blind, placebo-controlled, two-periods cross-over comparative trial -
Scientific Title:Acronym
The effect of the test diet on the absorption and excretion of water and electrolytes in the body in a heatstroke dehydration model
- A placebo-controlled, double-blind, cross-over trial-
Region
| Japan |
Condition
Condition
Dehydration, heat stroke
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the absorption and excretion rate of water by intake of the test diet using a heatstroke dehydration model induced by sauna stress in male subjects aged over 20 years.
The secondary endpoint is to compare the electrolytes similarly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body weight after sauna stress
Key secondary outcomes
Hematologic test
Blood biochemistry test
Urinalysis
Physiological test
Fractional Excretion of Sodium
Electrolyte balance
Water balance
Physical symptoms
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
The test diet of the equal amount of body weight loss after sauna stress is separately given by three times.
Interventions/Control_2
The placebo diet of the equal amount of body weight loss after sauna stress is separately given by three times.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Males aged 20 or older on the day of consent acquisition.
2. Body weight is over 50 kg.
3. Percent Body fat is below or equal to 25 percent.
4. Those who can use smartphones or PC to record a digital diary.
5. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent.
Key exclusion criteria
1. Those who regularly use foods or supplements with functional health claims that may affect the study outcome three times or more a week and cannot stop them from the time of consent acquisition (e.g., health foods containing capsaicin, spices, or other strong stimulants that have effects such as improving blood flow, increasing body temperature, or inducing sweating).
2. Currently receiving drug therapy (however as-needed medication is acceptable.) .
3. Heavy alcohol drinker with a habit of drinking over an average of 40 g/day per week.
4. Those who have difficulty with blood sampling.
5. Those who have a tattoo.
6. Those who feel difficulty with sweating in a sauna bath.
7. Subjects without body weight fluctuation due to sweating.
8. Those who can't enter a sauna bath for ten minutes three times.
9. Those who can't enter an one person sauna bath due to claustrophobia.
10. Those who have a scar for a burn injury in a wide area on the body.
11. Those who have severe diseases or a history of severe diseases in the heart, liver, kidney, or digestive organs.
12. Those who have allergies to drugs or foods.
13. Those who are participating in clinical studies of other drugs or health foods, within 4 weeks after the end of the study, or who plan to participate in other clinical studies after consenting to participate in the study.
14. Those who donated blood components or whole blood of 200 mL within one month before the start of the study.
15. Those who have blood donation above 400 mL within three months before the start of the study.
16. Those whose total blood collection volume, including the planned volume for the study and the volume collected in the previous 12 months, exceeds 1200 mL prior to the initiation of the study.
17. Those who are deemed unsuitable for participation in the study by the principal investigator or the sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Saeki |
Organization
GOSHU YAKUHIN CO., LTD.
Division name
Research and Development Department
Zip code
939-8201
Address
1-1-5, Hanazono-cho, Toyama 939-8201,JAPAN
TEL
076-424-2661
saeki@goshu.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
GOSHU YAKUHIN CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
GOSHU YAKUHIN 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2024 | Year | 01 | 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
| 2023 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060850
