Unique ID issued by UMIN | UMIN000054163 |
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Receipt number | R000061851 |
Scientific Title | Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Jelly on a Sauna-Induced Dehydration Model in Healthy Adults. |
Date of disclosure of the study information | 2024/04/22 |
Last modified on | 2024/04/16 10:25:55 |
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Jelly on a Sauna-Induced Dehydration Model in Healthy Adults.
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Jelly on a Sauna-Induced Dehydration Model in Healthy Adults.
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Jelly on a Sauna-Induced Dehydration Model in Healthy Adults.
Investigation of the Water and Electrolyte Replenishment Effects of an Electrolyte Replenishing Jelly on a Sauna-Induced Dehydration Model in Healthy Adults.
Japan |
No
Not applicable | Adult |
Others
NO
To examine the water and electrolyte replenishing effects of the electrolyte replenishing jelly, using a sauna-induced dehydration model in healthy adults.
Bio-equivalence
Fractional excretion of sodium
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
Others:
Body weight, Plasma volume, body water balance, body electrolyte balance , body temperature, blood pressure, pulse
Interventional
Cross-over
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Food |
Sequence group 1:
Period I, intake of electrolyte replenishment drink; Washed out period, four days or more; Period II, Intake of electrolyte replenishment jelly.
Sequence group 2:
Period I, intake of electrolyte replenishment jelly; Washed out period, four days or more; Period II, Intake of electrolyte replenishment drink.
20 | years-old | <= |
Not applicable |
Male
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 input data into the logbook using electronic tools such as PCs, or smartphones.
4) Those who can make self-judgment and are voluntarily giving written informed consent.
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.
30
1st name | Takayoshi |
Middle name | |
Last name | Fujii |
Ajinomoto Co., Inc.
Nutrition Care Group Consumer Food Products Development
104-0031
1-15-1, Kyobashi, Chuo-Ku,Tokyo
080-1038-6547
takayoshi.fujii.9qx@asv.ajinomoto.com
1st name | Ryo |
Middle name | |
Last name | Uchida |
Ajinomoto Co., Inc.
Functional Ingredients Development Group, Wellness Value Creation Center, Institute of Food Sciences
210-0801
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
08010556257
ryo.uchida.xs6@asv.ajinomoto.com
IMEQRD Co., Ltd.
Ajinomoto Co., Inc.
Profit organization
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
医療法人社団 成守会 はせがわ病院(東京都)
2024 | Year | 04 | Month | 22 | Day |
Unpublished
Preinitiation
2024 | Year | 03 | Month | 26 | Day |
2024 | Year | 06 | Month | 03 | Day |
2024 | Year | 06 | Month | 14 | Day |
2024 | Year | 04 | Month | 16 | Day |
2024 | Year | 04 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061851
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