Healthy subjects
Conditions
Interventions
Continuous intake of the food containing plant extract for 12 weeks.
Continuous intake of the food not containing plant extract for 12 weeks.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are aged 40 years or older and younger than 60 years at the time of written informed consent. 2.Subjects with a T-score for the vigor-activity (VA) scale of 50 or lower and a T-score for the fatigue-inertia (FI) scale of 50 or higher on the POMS 2-A short. 3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history of gastrointestinal resection. 2.Subjects who are being treated for serious illness or who have required medication for serious illness. 3.Subjects with current or previous history of an autoimmune disease. 4.Subjects with current or previous history of a psychiatric disorder, chronic fatigue syndrome, or insomnia. 5.Subjects with previously diagnosed or suspected sleep apnea syndrome. 6.Subjects currently under treatment related to sleep, stress, or fatigue. 7.Subjects engaged in irregular hours of work, work in day and night shifts, or manual labor such as carrying heavy materials. 8.Subjects who are regularly using pharmaceutical products, products designated as "food for specified health uses" or other categories of "health food," or other products that may affect the study. 9.Subjects who may develop allergies related to the study. 10.Subjects who eating, sleeping, and other habits are extremely irregular. 11.Heavy users of alcohol or excessive smokers. 12.Subjects who plan to travel abroad, including business trips, or who plan to travel or business trips in the country for seven or more consecutive days during the study. 13.Subjects who participated in other clinical study within 3 months before the date of informed consent or who plan to participate in other clinical study during the study period. 14.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent. 15.Subjects who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period. 16.Subjects who have difficulty complying with recording of each survey form. 17.Subjects whose laboratory test values or various test results at screening indicate their ineligibility to participate in the study. 18.Other Subjects who are considered ineligible for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS 2-A short T score | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) SF-36v2, Apathy Scale, Anti-Aging QOL Common Questionnaire, SCD-Q (Safety evaluation) Vital signs, physical measurements(body weight and BMI), biochemical test, hematology test, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed