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A Study on the Effect of Plant-Derived Product on Immune Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Not Applicable
Conditions
o
Registration Number
JPRN-UMIN000043386
Lead Sponsor
TOYO SHINYAKU Co., Ltd.
Brief Summary

Statistically significant difference was confirmed in the salivary sIgA secretion rate.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
38
Inclusion Criteria

Not provided

Exclusion Criteria

Subjects (who) (1)have a faster salivary sIgA secretion rate. (2)have a constipation tendency. (3)contract diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). (4)have a chronic disease and regularly use medications. (5)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting immune functions. (6)can't stop taking foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or live bacteria during test periods. (7)get intense exercises (e.g., muscle training in the gym) more than 3 times a week. (8)are under treatment for periodontal disease. (9)used antibiotics within the last two weeks prior to the screening. (10)can't stop drinking from a day before each measurement. (11)have declared an allergic reaction to test foods. (12)have a history and/or a surgical history of digestive disease affecting digestion and absorption. (13)plan to become pregnant after informed consent, pregnant or lactating. (14)are under treatment for or have a history of drug addiction and/or alcoholism. (15)are shiftworker and/or midnight-shift worker. (16)are participating and/or had participated and/or are planning to participate in other clinical studies that affect this study. (17)with skin disease, such as atopic dermatitis. (18)with strange skin conditions at measurement points. (19)neglect skin care. (20)can't avoid direct sunlight exposure, such as sunburn, during test periods. (21)had been conducted an operation or beauty treatment on the test spot in the past 6 months. (22)are judged unsuitable for the study by the investigator for other reasons.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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