None listed
Conditions
Interventions
[1]Oral ingestion of a test food (10 tablets/single dose, 2 weeks). [2]Observation. [3]Washout (over 13days). [4]Oral ingestion of a control food (10 tablets/2 weeks). [5]Observation.
[1]Oral inge
Sponsors
Seishukai Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese males aged 20-64 years. 2) Individuals whose written informed consent has been obtained after explanation of this study.
Exclusion criteria
Exclusion criteria: 1) Individuals who have taken drugs that could potentially affect the study for 1 month prior to the pre-test, or who cannot limit their use from the pre-test to the end of the study (except for a history of medication such as headache, common cold, etc.). 2) Individuals with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness. 3) Individuals who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals with serious anemia. 6) Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2. 7) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 8) Individuals who have been taking functional foods, health foods, or supplements on a continuous basis at present or within the past month, and those who are planning to take them during the study period. 9) Individuals who experienced unpleasant feeling during blood drawing. 10) Individuals with drug and food allergies. 11) Smokers or those who have quit smoking for less than 6 months. 12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 13) Shift workers, late-night workers, and others with irregular life rhythms. 14) Individuals who participated in other clinical studies in the past 1 month. 15) Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| miRNA in blood(miRNA levels and their changes) Observation period I and II | — |
Secondary
| Measure | Time frame |
|---|---|
| *Safety 1) Blood pressure, pulsation. (1) 2) Weight,body fat percentage,BMI. (1) 3) Doctor's questions/ Adverse events. (1) 4) Diary written while living. (2) (1): Observation period I and II (2): Written daily from observation period I to the day before observation period II | — |
Countries
Japan
Contacts
Public ContactKoichi Sudo
Seishukai Clinic Clinical trial office
Outcome results
None listed