Healthy subjects
Conditions
Interventions
8-week intake of the test food
8-week intake of the placebo food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 40 and over, below 60 2) Males and females with Japanese nationality 3) Profile of Mood States (POMS2) Short Form Fatigue - Inertia T Score: 60 and over 4) Daytime workers who are not primarily engaged in physical labor but are engaged in sales, clerical work, administrative work, etc. 5) Persons who wake up same time every morning 6) Scoring of Immunological Vigor (7 items): 10 to 18 7) Persons who are able to take 6 tablets/day for 8 weeks on the continuous basis
Exclusion criteria
Exclusion criteria: 1) Currently in treatment with medication or seeing a doctor for treatment 2) A positive test result on hepatitis B 3) Allergic to food, medication, pollen, or with another type of allergic disease 4) Regular intake of medication with a possible influence on an immune function (antibiotics, immunosuppressive drugs, anti-inflammatory drugs, anti-rheumatic drugs, antihistamines, anti-allergy drugs, lactobacillus preparation, etc.) 5) Vaccinated within the past 3 months or desired to be vaccinated during a study period 6) Current habit of smoking 7) Extreme faddiness 8) Extremely irregular lifestyle including an irregular eating pattern, a irregular sleep pattern, etc. 9) Presence or previous history of a mental disorder (depression, etc.) 10) Regular intake of any one of food (mushrooms, barley, seaweeds), health food products, and supplements with high content of beta-glucan 11) High alcohol intake (alcohol intake of 60 g and over per day) 12) Engaged in active sports resulted in shortness of breath, such as jogging, marathon, or soccer. 13) Currently participating another clinical study or participation in another clinical study within the past 3 months 14) Determined by the investigator to be unsuitable for enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of each leukocyte subset 2.T-cell blastogenesis 3.NK activity 4.POMS2 (Short Form) Fatigue - Inertia T score 5.Brief Job Stress Questionnaire 6.Chalder fatigue scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.IgA in feces 2.OSA Sleep Inventory 3.Fecal Questionnaire | — |
Countries
Japan
Contacts
Public ContactMatsuoka Masao
HUMA R&D CORP Clinical Development Division
Outcome results
None listed