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Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue

Not Applicable
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000028048
Lead Sponsor
HUMA R&D CORP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
1.IgA in feces 2.OSA Sleep Inventory 3.Fecal Questionnaire
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