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

UMIN ID: UMIN000056236

Registered date:22/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2024/11/23
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Plant-Derived Products, 8 weeks consumption
Placebo Products, 8 weeks consumption

Outcome(s)

• Primary Outcome: cDC activity after 8 weeks consumption Physical condition questionnaire up to 8 weeks consumption
• Secondary Outcome: cDC-related immune marker after 8 weeks consumption

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Subjects(who) 1) contract, are under treatment for or have a history of serious diseases (e.g., diabetes, kidney/liver disease, heart disease, thyroid disease, adrenal disease and/or metabolic disease). 2) have a chronic disease and regularly use medications. 3) contract pollinosis, allergic rhinitis, atopic dermatitis, bronchial asthma, or chronic bronchitis. 4) have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5) can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber during this study. 6) can't stop using supplements and/or functional foods (including Foods with Function Claims) affecting immune functions. 7) are smokers. 8) have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent. 9) have declared allergic reaction to ingredients of test foods. 10) can't stop drinking from 2 days before each measurement. 11) are under treatment for or have a history of drug addiction and/or alcoholism. 12) are shiftworker, midnight worker and/or physical labor. 13) are judged as unsuitable for the study by blood tests in screening test. 14) plan to become pregnant after informed consent, pregnant or lactating. 15) have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the screening test. 16) have a habit of strenuous exercise such as running or soccer. 17) are planning to go abroad, such as on an overseas trip. 18) have used drugs (including antiallergic drugs and antibiotics) that are thought to affect immune function within 2 weeks prior to the screening test. 19) are planning to participate and/or had participated in other clinical studies within the last 1 month prior to the current study. 20) are judged unsuitable for the study by the investigator for other reasons.

Related Information

• Primary Sponsor: KSO Corporation
• Source(s) of Monetary Support: TOYO SHINYAKU Co., Ltd.