Healthy male adults
Conditions
Interventions
Freely consumption of the test/placebo food (two bottles a day) to the subject for five days at home.
On admission, consumption of the test/placebo food (two bottles a day) to the subject at the appoi
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy male subjects ranging in age from 20 to 64, at informed consent. (2) Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2. (3) Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who have any difficulty in doing exercises with a bicycle ergometer for approximately 30 min. (2) Subjects falling into the habit of excessive alcohol intake. (3) Subjects who have the habit of smoking, at the present time and/or within a year before this trial. (4) Subjects with extremely irregular life rhythm. (5) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (6) Subjects being under some kind of continuous medical treatment, and/or planning to have it during this trial. (7) Subjects having drug and/or food allergy. (8) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within four weeks before this trial, or will join those after giving informed consent to participate in this trial. (9) Subjects who donated 400 mL of their whole blood within the last three months before this trial. (10) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changing rate of core-body temperature (drum temperature) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body weight-changing rate 2. Plasma volume-changing rate 3. Total protein 4. Albumin 5. Serum sodium 6. Serum osmolality 7. Fractional excretion of sodium 8. Creatinine clearance 9. Free water clearance 10. Voided volume 11. Bloodstream (OMEGAZONE) 12. Heartbeat rate (Polar Unite) 13. Subjective symptoms based on a visual analog scale questionnaire (feebleness, thirst, hotness) | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed