UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055897 |
|---|---|
| Receipt number | R000063480 |
| Scientific Title | A Comparative Study of the Absorption Rate and Excretion Efficiency of Water and Electrolytes in the Body After Consumption of a Study Food Product (Liquid). |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2025/05/16 18:20:08 |
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Basic information
Public title
A Comparative Study of the Absorption Rate and Excretion Efficiency of Water and Electrolytes in the Body After Consumption of a Study Food Product (Liquid).
Acronym
A Comparative Study of the Absorption Rate and Excretion Efficiency of Water and Electrolytes in the Body After Consumption of a Study Food Product (Liquid).
Scientific Title
A Comparative Study of the Absorption Rate and Excretion Efficiency of Water and Electrolytes in the Body After Consumption of a Study Food Product (Liquid).
Scientific Title:Acronym
A Comparative Study of the Absorption Rate and Excretion Efficiency of Water and Electrolytes in the Body After Consumption of a Study Food Product (Liquid).
Region
| Japan |
Condition
Condition
Male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the water and electrolytes contained in the test food product are appropriately absorbed into the body and contribute to the improvement of heat stroke symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body weight
Key secondary outcomes
Hematological tests
Blood biochemical tests
Urinalysis
Physiological tests
Fractional excretion of sodium levels (urinary sodium)
Electrolyte balance
Water balance
Questionnaire on skin symptoms and thirst perception
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral consumption of the test food
Interventions/Control_2
Oral consumption of the 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Men aged 20 years or older at the time of consent acquisition.
2. Subjects with a body weight 50 kg or more
3. Subjects with a body fat percentage of 25% or less
4. Subjects who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Subjects who regularly consume Foods for Specified Health Uses (FOSHU), foods with functional claims, or health supplements (including supplements) three or more times per week and are unable to discontinue their use at the time of consent acquisition.
(Examples: Health foods containing capsaicin, spices or other highly stimulating ingredients, health foods that improve blood flow, raise body temperature or cause sweating)
2. Subjects undergoing medication treatment at the time of consent acquisition (occasional use of medication is allowed).
3. Subjects with excessive alcohol intake.
4. Subjects who have difficulty with blood collection.
5. Subjects who have a tendency to experience diarrhea or immediately feel the need to defecate after consuming food or drink.
6. Subjects with tattoos.
7. Subjects who do not sweat easily in a sauna.
8. Subjects who are claustrophobic and cannot enter a one-person sauna.
9. Subjects with extensive burn scars.
10. Subjects with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
11. Subjects with allergies to medications and/or food.
12. Subjects who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
13. Subjects who donated 200 mL of their blood or blood components within the last month.
14. Subjects who donated 400 mL of his blood within the last 3 months.
15. Subjects who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
16. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Seishukai Clinic Institutional Review Board
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
03-5827-0930
t-takahama@seishukai.or.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 | 10 | Month | 21 | 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
22
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 | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 18 | 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 | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063480
