Effects of consumption of the test food on body temperature of healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000036209
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Kanai T, Suzuki N, Yamashita S, Morimoto Y, Takara T. Verification of the Effects of Capsules Containing Allium victorialis subsp. platyphyllum Extract on the Body Temperature of Healthy Japanese Adults-A Randomized, Double-blind, Placebo-controlled Clinical Trial-. Jpn Pharmacol Ther. 2020; 48(2): 243-257.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 58
Not provided
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, and sinus tachycardia. 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, hypothyroidism, or any other chronic diseases. 4. Subjects who are undergoing medical treatment of blood disorders. 5. Subjects who are undergoing medical treatment of anemia. 6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 7. Subjects who are currently taking medications (including herbal medicines) and supplements. 8. Subjects who drink alcoholic beverages to excess {Average amount of alcohol intake is approximately 60 g per day converted into absolute alcohol (approximately 540 mL of Japanese sake, 3 cans (500 mL/can) of beer, or 300 mL of distilled spirits)} 9. Subjects who cannot immerse their hands in water during the cold season (Those who change their fingertips purple or white when they are immersed in water). 10. Subjects who are allergic to medicines and/or the test food related products. 11. Subjects who are pregnant, lactation, or planning to become pregnant. 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period. 13. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Basal body temperature on awakening * Measure daily body temperature on awakening from 1 week before screening (before consumption) * Measure daily body temperature on awakening from the start consumption to the day before 4-week examination. * Assess the average body temperature on awakening per week.
- Secondary Outcome Measures
Name Time Method 1. Palmar Skin Temperature 2. Subjective symptoms (the Likert scale) * Measure the values before and after cold water load at screening (before consumption) and 4 weeks after consumption and calculate the amount of change.