Unique ID issued by UMIN | UMIN000049917 |
---|---|
Receipt number | R000056842 |
Scientific Title | Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -double-blind two-periods crossover trial- |
Date of disclosure of the study information | 2022/12/27 |
Last modified on | 2023/07/13 18:27:40 |
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -double-blind two-periods crossover trial-
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes. -double-blind two-periods crossover trial-
Comparative study for the effect of test diets on the absorption and excretion of the body water and electrolytes
Japan |
Dehydration
Not applicable |
Others
NO
To compare the effect of the test diets on absorption rate and excretion efficiency of the body water and electrolytes.
Safety,Efficacy
Body weight change
Hematologic test
Blood biochemistry
Urinalysis
Physiological test
Fractional Excretion of Sodium
Electrolyte balance
Water balance
Subjective questionnaires for skin symptoms and thirst
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Take the test diet equal to the same amount of body weight loss by three times.
Take the control diet equal to the same amount of body weight loss by three times.
20 | years-old | <= |
Not applicable |
Male
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. Received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent.
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 60g/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 who can't enter a sauna bath for one person due to claustrophobia.
8. Have a scar for a burn injury in a wide area on the body.
9. Have severe diseases or a history of severe diseases in the heart, liver, kidney, or digestive organs.
10. Have allergies to drugs or foods.
11. 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.
12. Have above 200 mL blood donation within one month before the start period of the study.
13. Have above 400 mL blood donation within three months before the start period of the study.
14. 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.
15. Who are unsuitable for the study, judged by the principal investigator.
15
1st name | Kosuke |
Middle name | |
Last name | Motokawa |
Coca-Cola (Japan) Company, Limited
Sports Category, Marketing
150-0002
6-3, Shibuya 4-Chome, Shibuya-Ku, Tokyo 150-0002
03-5466-8000
kmotokawa@coca-cola.com
1st name | Hira |
Middle name | |
Last name | Yoshitada |
IMEQRD Co., Ltd
Sales department
104-0061
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
0367045968
y-hira@imeqrd.co.jp
IMEQRD Co., Ltd
Coca-Cola (Japan) Company, Limited
Profit organization
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
0367045968
n-yuzawa@imeqrd.co.jp
NO
2022 | Year | 12 | Month | 27 | Day |
Unpublished
15
Completed
2022 | Year | 11 | Month | 04 | Day |
2022 | Year | 11 | Month | 29 | Day |
2023 | Year | 02 | Month | 06 | Day |
2023 | Year | 02 | Month | 16 | Day |
2022 | Year | 12 | Month | 27 | Day |
2023 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056842
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |