A Study on the Effect of Plant-Derived Product on Body Temperature -A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- Conditions
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- Registration Number
- JPRN-UMIN000045227
- Lead Sponsor
- TOYO SHINYAKU Co., Ltd.
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
Subjects (who) 1) contract and/or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease). 2) have a chronic disease and use medications. 3) have a history and/or a surgical history of digestive disease affecting digestion and absorption. 4) may have allergy to test foods. 5) use medications affecting body temperature. 6) can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting body temperature during test periods. 7) are planning to become pregnant after informed consent, pregnant or lactating. 8) are under treatment for or have a history of drug addiction and/or alcoholism. 9) are shift worker and/or midnight-shift worker. 10) had been conducted an operation or beauty treatment on the test spot in the past 6 months. 11) are participating and/or are planning to participate in other clinical studies that affect this study after informed consent. 12) are judged unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Core body temperature
- Secondary Outcome Measures
Name Time Method Body surface temperature (only male subjects are measured)