UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051933 |
|---|---|
| Receipt number | R000059256 |
| Scientific Title | Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Drink on a Sauna-Induced Dehydration Model in Healthy Adults. |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2024/02/16 11:01:01 |
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Basic information
Public title
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Drink on a Sauna-Induced Dehydration Model in Healthy Adults.
Acronym
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Drink on a Sauna-Induced Dehydration Model in Healthy Adults.
Scientific Title
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Drink on a Sauna-Induced Dehydration Model in Healthy Adults.
Scientific Title:Acronym
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Drink on a Sauna-Induced Dehydration Model in Healthy Adults.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the water and electrolyte replenishing effects of the electrolyte replenishing drink, using a sauna-induced dehydration model in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Blood tests:
White blood cells, red blood cells, hemoglobin, hematocrit, platelet, Na, K, Cl, Ca, total protein, albumin, blood urea nitrogen, creatinine, glucose, serum osmolality
Urine tests:
Urine volume, urine specific gravity, urine osmolality, Na, K, Cl, Mg, Ca, creatinine, urine urea nitrogen, inorganic phosphorus ion, urine protein, urine sugar, urobilinogen, bilirubin, occult blood
Fractional excretion of sodium, body water balance, body electrolyte balance , body temperature, blood pressure, pulse, general symptom questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Sequence group 1:
Period I, intake of electrolyte replenishment drink; Washed out period, four days or more; Period II, Intake of mineral water.
Interventions/Control_2
Sequence group2:
Period I, intake of mineral water; Washed out period, four days or more; Period II; Intake of electrolyte replenishment drink.
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)Healthy male aged 20 years or older on the date of informed consent.
2)Those who are 50kg or over of body weight and BMI within from 18.5 kg/m^2 or over to 25.0 kg/m^2 or less.
3)Those who can stay overnight from the day before the test.
4)Those who can input data into the logbook using electronic tools such as PCs, or smartphones.
5)Those who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1)Have donated 400 mL of whole blood 3 months before the screening.
2)Have donated 200 mL of whole blood or blood components 1 month before the screening.
3)The sum of donated blood volume in the study and donation within 12 months before the screening test is over 1200 mL.
4)Have been comprehensively judged by the principal investigator to require treatment for dehydration based on clinical indicators at the screening test.
5)Who participated in a study involving the use of other foods or drugs, or the application of cosmetics or drugs within 4 months before obtaining consent, or who will participate in other studies while participating in this study.
6)Currently undergoing treatment with some kind of drug or herbal medicine.
7)Currently taking over-the-counter drugs, quasi-drugs and foods or supplements with specified health claims or who cannot withdraw these during the study period.
8)Heavily drinkers (40g or more as pure alcohol).
9)Have unstable lifestyles such as shift workers, and night shifts.
10)Have a smoking habit (less than 1 year after quitting smoking).
11)May change lifestyles such as long-term travel during the study.
12)Have a habit go to a sauna (at least over once a month), or have never experienced a sauna.
13)Have extensive burn scars.
14)Have tattoos.
15)Have Claustrophobia and unable to be in sauna.
16)Have drug addiction, or have been drug addicted.
17)Have difficulty with blood donation, or have experienced bad mood, deterioration of physical condition, or vasovagal reflex due to blood collection in the past.
18)Have a history or current medical history of heatstroke.
19)Have a history or current medical history of severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, etc.
20)Those who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Fujii |
Organization
Ajinomoto Co., Inc.
Division name
Nutrition Care Group Quick Nourishment Department
Zip code
104-8315
Address
1-15-1, Kyobashi, Chuo-Ku,Tokyo
TEL
080-1038-6547
takayoshi.fujii.9qx@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Uchida |
Organization
Ajinomoto Co., Inc.
Division name
Functional Ingredients Development Group, Wellness Value Creation Center, Institute of Food Sciences
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
080-1055-6257
Homepage URL
ryo.uchida.xs6@asv.ajinomoto.com
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
医療法人社団 成守会 はせがわ病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | 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
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 | 07 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 06 | 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 | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059256
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| Registered date | File name |
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| Registered date | File name |
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