UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054399 |
|---|---|
| Receipt number | R000062141 |
| Scientific Title | Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load: an open-label, randomized, two-periods cross-over comparative controlled trial |
| Date of disclosure of the study information | 2024/05/26 |
| Last modified on | 2024/08/01 10:44:56 |
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Basic information
Public title
Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load.
Acronym
Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load.
Scientific Title
Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load: an open-label, randomized, two-periods cross-over comparative controlled trial
Scientific Title:Acronym
Study on the effects of test food intake on absorption and excretion of water and electrolytes in the body under the dehydration model with sauna load: an open-label, randomized, two-periods cross-over comparative controlled trial
Region
| Japan |
Condition
Condition
Dehydration, heatstroke
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the absorption rate and excretion rate of water in the body by consumption of test food under the heatstroke dehydration model with sauna load, in male subjects aged over 20 years. As a secondary objective, electrolytes are to be compared as well.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Changes in body weight after sauna bathing
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
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
The test food is consumed in three divided doses equal to the amount of weight loss after the sauna bathing.
Interventions/Control_2
The control food is consumed in three divided doses equal to the amount of weight loss after the sauna bathing.
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 at the time of consent.
2. Whose Body weight is 50 kg or more.
3. Whose body fat percentage is 25% or less.
4. Those who are able to input data into an electronic diary by PC, smart phone, etc.
5. Those who have received a full explanation of the objective and content of the study, understand it well, and voluntarily volunteer to participate, and agree to participate in the study in writing.
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 using them from the time of consent (e.g., Health foods containing capsaicin, spices, or other strong stimulants, or Health foods that have effects such as improving blood flow, increasing body temperature, or inducing sweating).
2. Those who are currently receiving drug treatment (however, ad-hoc treatment is allowed).
3. Heavy drinkers (those with excessive drinking habits exceeding approximately 40 grams of pure alcohol equivalent per day).
4. Those who have difficulty in blood collection or have had a history of feeling sick immediately after blood collection, such as vagal reflex in the past.
5. Those with tattoos.
6. Those who have no experience in sauna.
7. Those who are aware that they have difficulty sweating in sauna.
8. Those who cannot enter an one-person sauna because of claustrophobia.
9. Those who have extensive burn scars.
10. Those with a history or current history of serious heart, liver, kidney, or digestive organ disease.
11. Those who are allergic to medicines or foods.
12. Those who are currently participating in a clinical study on other drugs or health foods, who had participated in a clinical study on other drugs or health foods within 4 weeks, or who are scheduled to participate in the other clinical study after the consent to participate in this study.
13. Those who have donated blood components or 200 mL of whole blood in the month prior to the start of the study.
14. Those who have donated 400 mL of whole blood 3 months prior to the start of the study.
15. 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 start of the study.
16. Whose participation in the study is deemed inappropriate by the principal investigator or subinvestigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Akimoto |
Organization
KOKANDO Co., Ltd.
Division name
Corporate Officer Research Development Manager
Zip code
930-0158
Address
Innovation Center 1602-1 Ikeda, Toyama City, Toyama (in the Kureha Minami Industrial Park, Toyama-shi), Japan
TEL
076-476-5622
k.akimoto@koukandou.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
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOKANDO 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
0367045968
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 | 05 | Month | 26 | 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
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062141
