Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059306) titled 'A study to investigate the effects of consuming the test products on immune function' on Oct. 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - KSO Corporation

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of test products on immune function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Test food Interventions/Control_2 - Duration: 12 weeks Test product: Placebo food

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy Japanese men and women aged 20 years or older and under 65 years old at the time of consent 2) Individuals who are aware that they are susceptible to colds and influenza 3) Individuals who have received a full explanation of the purpose and content of this study, are competent to consent, fully understand the contents, and voluntarily volunteer to participate, and who provide written consent to participate in this study. Key exclusion criteria - 1) Suffering from or currently undergoing treatment for serious diseases such as diabetes, kidney disease, liver disease, or heart disease, thyroid disease, adrenal gland disease, psychiatric disease, autoimmune disease, or other metabolic diseases 2) Chronic diseases and regular medication use 3) Atopic dermatitis, bronchial asthma, or chronic bronchitis 4) Planning to visit a doctor or take prescription medication annually for hay fever or allergic rhinitis 5) History or current history of drug or alcohol dependence 6) History of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption 7) Unable to stop taking supplements or health foods that may affect their immune system during the study period 8) Smoking habit 9) Excessive alcohol consumption 10) Unable to stop taking alcohol for two days prior to the screening test or any other test 11) Declared a food allergy to any component of the study products 12) Day-night shift workers, late-night workers, workers who work from home, and workers engaged in physical labor such as transporting heavy objects 13) Pregnant, intend to become pregnant during the study period, or breastfeeding 14) Unsuitable for study participation based on the blood test results of the screening test 15) Scheduling to receive vaccinations for infectious diseases from one month prior to the screening test until the end of the 12-week test after the start of intake. 16) Scheduling to travel abroad during the study period. 17) Taken antibiotics within one month prior to the screening test. 18) Drawn or donated more than 200 mL of blood within one month or more than 400 mL within three months prior to the consent date. 19) Currently participating in or intend to participate in the trials involving the intake of other foods or pharmaceuticals, or the application of cosmetics. 20) Judged unsuitable for study participation by the principal investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 24 Day Date of IRB - 2025 Year 09 Month 25 Day Anticipated trial start date - 2025 Year 10 Month 09 Day Last follow-up date - 2026 Year 01 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067759

Disclaimer: Curated by HT Syndication.