UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052372 |
|---|---|
| Receipt number | R000059785 |
| Scientific Title | Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -an open-label, randomized, two-periods crossover comparative trial- |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/11/30 09:35:35 |
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Basic information
Public title
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes.
-an open-label, randomized, two-periods crossover comparative trial-
Acronym
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes.
-an open-label, randomized, two-periods crossover comparative trial-
Scientific Title
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes.
-an open-label, randomized, two-periods crossover comparative trial-
Scientific Title:Acronym
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes.
-an open-label, randomized, two-periods crossover comparative trial-
Region
| Japan |
Condition
Condition
Heat stress disorder
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of the test diets on absorption rate and excretion efficiency of the body water and electrolytes in male adults 20 and more aged.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intervention difference of changes in body weight after sauna bath
Key secondary outcomes
Hematologic test
Blood biochemistry
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
Open -no one is 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
Take the test diet equal to the same amount of body weight loss after sauna by three times.
Interventions/Control_2
Take the placebo diet equal to the same amount of body weight loss after sauna 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 more than twenty on the day of consent acquisition.
2. Body weight is over 50 kg.
3. 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. Have been taking foods or supplements with functional health claims, which affect the study outcome, such as capsaicin, spices, or any stimulus functional foods for blood flow or body temperature improvement, more than three times a week, and who can't also discontinue intake of these foods.
2. Currently receive medical treatments with drugs. Medications used as needed are acceptable.
3. Alcohol drinking over an average of 40 g/day per week.
4. Have difficulty with blood sampling.
5. Those who have a tattoo.
6. Have difficulty with sweating in a sauna bath.
7. Those whose weight does not fluctuate due to sweating
8. Those who can't enter a sauna bath for ten minutes three times.
9. Those who can't enter a sauna bath for one person due to claustrophobia.
10. Have a scar for a burn injury in a wide area on the body.
11. Have severe diseases or a history of severe diseases in the heart, liver, kidney, or digestive organs.
12. Have allergies to drugs or foods.
13. Those who joined other clinical trials four weeks before, those who have currently joined other clinical trials, and who are planning to join other clinical trials after the consent acquisition in the study.
14. Have above 200 mL blood donation within one month before the start period of the study.
15. Have above 400 mL blood donation within three months before the start period of the study.
16. Have above 1200 mL blood donation volume, which is the sum of the planned blood donation volume in the study and the previous donated blood volume within twelve months before the start period of the study.
17. Those who are unsuitable for the study, judged by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Tai |
Organization
AKO KASEI CO., LTD.
Division name
Technical Development Division
Zip code
678-0193
Address
Sakoshi, Ako-shi, Hyogo-ken 678-0193
TEL
0791-48-1722
htai@ako-kasei.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
n-yuzawa@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
| 2023 | Year | 10 | Month | 10 | 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 | 09 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 08 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059785
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| Registered date | File name |
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