Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058745) titled 'A Study on the Immunostimulatory Effects of the Test Food -A Randomized, Double-blind, Parallel-group Study-' on Aug. 19.

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 examine the effects of the test food on immune function, primarily IgA, in healthy adults for eight weeks. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consumption of the test food (1 pack a day, 8 weeks) Interventions/Control_2 - Consumption of the placebo food (1 pack a day, 8 weeks)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Participants aged 20 to 64 years 2. Japanese men and women 3. BMI over 18.5 and less than 30.0 kg/m^2 4. History of upper respiratory tract infection at least once per year 5. Able to enter electronic diaries via smartphone or PC 6. Sufficiently informed about the study and voluntarily consented in writing Key exclusion criteria - 1. Currently receiving treatment for any disease with medication or Kampo (as-needed use allowed) 2. Under physician-supervised dietary or exercise therapy 3. History or presence of serious illness 4. History of gastrointestinal surgery (except appendicitis) 5. Atopic dermatitis, allergic rhinitis (seasonal/perennial), bronchial asthma, chronic bronchitis, or other immune-related diseases (e.g., autoimmune diseases) 6. Current or past treatment for dry mouth or Sjogren's syndrome 7. Consumes yogurt, lactic acid bacteria, or bifidobacteria foods at least 3 times per week, or unwilling to refrain during the study 8. Currently taking quasi-drugs, FOSHU, FFC, supplements, or health foods (allowed if discontinued after consent) 9. Plans to use drugs affecting immune function or gut flora (e.g., antiallergics, antibiotics) during the study 10. Vaccinated against influenza, COVID-19, etc., within 1 month before consent, or plans to be vaccinated during the study 11. Participants with current or past drug or food allergies 12. Irregular lifestyle due to night or shift work 13. Plans to significantly change lifestyle (diet, sleep, exercise) during the study 14. Heavy alcohol consumption (more than or equal to 40g per day) 15. Excessive smoking (more than or equal to 21 cigarettes per day) 16. Plans for overseas travel during the study 17. Pregnant, breastfeeding, or planning pregnancy during the study 18. Currently using or planning to use oral contraceptives during the study 19. Donated more than 200mL of blood within 1 month or more than 400mL within 3 months before consent 20. Participated in other clinical studies within 1 month before consent, currently participating, or planning to participate during the study 21. Considered unsuitable for participation by the principal or sub-investigator Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 08 Day Date of IRB - 2025 Year 07 Month 15 Day Anticipated trial start date - 2025 Year 10 Month 15 Day Last follow-up date - 2025 Year 12 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066893

Disclaimer: Curated by HT Syndication.