Tokyo, Sept. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062965) titled 'Evaluation of the efficacy of 8-week continuous intake of the study food on immune function' on Sept. 22.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co. Ltd.

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

Objective: Narrative objectives1 - To assess the effects of 8-week intake of the study food on immune function in men and women aged 20 to under 60 years. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consume four capsules of the study food once daily after breakfast for 8 weeks. Interventions/Control_2 - Consume four capsules of the placebo food once daily after breakfast for 8 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Aged 20 to under 60 years 2. Japanese men and women 3. Have contact with others at least once a week through work or social activities 4. Have had an upper respiratory tract infection at least once a year 5. BMI of 18.5 or more and less than 30.0 kg/m^2 6. Able to enter electronic diary data via smartphone or PC 7. Received thorough explanation of the study, understand its purpose and content, voluntarily agreed to participate, and provide written informed consent Key exclusion criteria - 1. Currently receiving outpatient treatment for any illness or taking medications, including Kampo (as-needed use permitted) 2. Under physician-supervised dietary or exercise therapy 3. Current or past history of serious diseases 4. Have atopic dermatitis, allergic rhinitis (seasonal or perennial), bronchial asthma, chronic bronchitis, or other immune-related disorders 5. Consuming yogurt or foods containing lactic acid bacteria or bifidobacteria (eligible if discontinued after consent) 6. Currently taking quasi-drugs, Foods for Specified Health Uses, health foods, or supplements (participation allowed if discontinued after consent and during the study) 7. Lactose intolerance 8. Received vaccination for influenza, COVID-19, or similar infections within one month before screening, or plan to be vaccinated during the study 9. Current or past history of drug or food allergies 10. Habitual excessive alcohol consumption (>=40g pure alcohol/day) 11. Habitual excessive smoking (>=21 cigarettes/day) 12. Irregular lifestyle due to night shifts or rotating shifts 13. Plan to significantly change lifestyle habits (diet, sleep, exercise, etc.) during the study 14. Plan to travel abroad during the study 15. Pregnant, breastfeeding, or planning to become pregnant during the study 16. Blood donation of over 200 mL within 1 month or over 400 mL within 3 months prior to consent 17. Participation in another clinical study within 1 month before consent, currently participating, or planning to participate during the study 18. Deemed unsuitable for participation by the principal investigator Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Anticipated trial start date - 2026 Year 12 Month 07 Day Last follow-up date - 2027 Year 02 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072093

Disclaimer: Curated by HT Syndication.