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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-

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043386
Enrollment
40
Registered
2021-02-20
Start date
2021-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

TOYO SHINYAKU Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females aged 20 to 64 years-old. (2)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Salivary sIgA

Secondary

MeasureTime frame
Skin moisture content Physical condition questionnaire

Countries

Japan

Contacts

Public ContactNobutaka Kusaba

TOYO SHINYAKU Co., Ltd. Clinical and analytical research center

gakujutsu@toyoshinyaku.co.jp0942-81-3555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026