N/A(healthy adults)
Conditions
Interventions
[1]Oral intake of the test product (containing plant extract, 1 bottle in a day
2 weeks) [2]Observation [3]Washout (2 weeks) [4]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day
2 weeks) [5]Observation
[1]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day
2 weeks) [2]Observation [3]Washout (2 weeks) [4]Oral intake of the test product (containing plant extract, 1 bottle in a day
2 weeks) [5]Observation
Sponsors
TES Holdings Co. Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1]Healthy males aged 20-49 years [2]Individuals whose BMIs are over 20 and under 25 [3]Individuals who are healthy and have no disease [4]Individuals judged appropriate for the study by the principal [5]Individuals who can come to the designated venue for this study and be inspected [6]Individuals who are in the habit of walking or running and are capable of stopping these habits and conducting an exercise by ergometer [7]Individuals whose written informed consent have been obtained
Exclusion criteria
Exclusion criteria: [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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Fat oxidation during exercise (test period I, test period II) | — |
Secondary
| Measure | Time frame |
|---|---|
| *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) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co. Ltd Administrative Department of Clinical Trials
Outcome results
None listed