Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14)
- Conditions
- /A(healthy adults)
- Registration Number
- JPRN-UMIN000024142
- Lead Sponsor
- TES Holdings Co. Ltd
- Brief Summary
There was no significant difference in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 22
Not provided
[1]Individuals using medical products [2]Individuals who are sensitive to a test product [3]Individuals who will plan to go long term business trip or trip (more than 6 consecutive days) during test period [4]Individuals who are shift worker [5]Individuals who are difficult to participate due to have a liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases [6]Individuals with serious anemia [7]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day) [8]Individuals who are a smoker [9]Individuals who will be not capable of stopping to intake green tea, coffee and other beverage containing caffeine during the test period [10]Individuals who participated or will participate in other clinical studies [11]Individuals who have been medicated or operated in the past 2 months [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements (individuals who will stop to ingesting these foods at the begging of the test can participate into the study) [13]Individuals who have experience of bad feeling by blood sampling [14]Individuals who donated blood over 200mL in the past 1 month or have a plan to donate blood over 200mL. [15]Individuals who cannot intake test foods constantly during the test period [16]Individuals who cannot record a dietary record (for 6 days) [17]Individuals who deny to disclose past their own medical examination record [18]Individuals who cannot agree current informed consent [19]Individuals judged inappropriate for the study by the principal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Fat oxidation during exercise (test period I, test period II)
- Secondary Outcome Measures
Name Time Method *Secondary outcomes [1]Energy expenditure during exercise (screening, test period I, test period II) [2]Respiratory quotient during exercise (screening, test period I, test period II) [3]Fasting energy expenditure (screening, test period I, test period II) [4]Fasting fat oxidation (screening, test period I, test period II) [5]Fasting respiratory quotient (screening, test period I, test period II) [6]Blood examination (screening, test period I, test period II) [7]Urine analysis (screening, test period I, test period II) *Safety [1]Respiratory gas examination except indexes of primary and secondary outcomes (screening, test period I, test period II) [2]Blood examination (screening, test period I, test period II) [3]Urine analysis (screening, test period I, test period II) [4]Adverse event (each day during the test period) [5]Diagnosis by doctors (each day during the test period)