Validation research on body-temperature regulation by test-food intakes
- Conditions
- Healthy male adults
- Registration Number
- JPRN-UMIN000043913
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 15
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changing rate of core-body temperature (drum temperature)
- Secondary Outcome Measures
Name Time Method 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)