Clinical Trial: A Crossover Study Evaluating the Effects of Yogurt on Immunity, Microbiota, and Physical Condition in Healthy Adults Working in Commercial Facilities (Japan)

Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059465) titled 'A Crossover Study Evaluating the Effects of Yogurt on Immunity, Microbiota, and Physical Condition in Healthy Adults Working in Commercial Facilities' on Nov. 17.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Chiba University

Condition: Condition - Health Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This crossover study involving healthy adults working in commercial facilities will compare changes in salivary IgA levels, effects on oral and intestinal microbiota, and perceived health benefits, as measured by questionnaire surveys, between periods of yogurt consumption and non-consumption. The yogurt samples fermented with lactic acid bacteria strains OLL1073R-1 and OLS3059 will be evaluated. This study verifies the effects of yogurt consumption on immune function and holds significance for contributing to infection prevention. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Meiji Probio Yogurt R-1 Drink Type Interventions/Control_2 - Non-consumption period

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy adults who are not infected with any infectious disease at the time of registration 2) Individuals who, after receiving adequate explanation regarding participation in this study, provided written informed consent based on full understanding and of their own free will 3) Males or females aged 18 years or older at the time of consent acquisition 4) Individuals deemed by the principal investigator or sub-investigator to be able to comply with the protocol requirements Key exclusion criteria - 1) Individuals with serious illnesses (including significant laboratory abnormalities) that the principal investigator or sub-investigator determines may affect the interpretation of data or safety, or prevent safe conduct of protocol assessments 2) Individuals who participated in another clinical trial within 30 days prior to obtaining consent 3) Individuals with a history of hypersensitivity to yogurt or lactose intolerance 4) Individuals with a history of severe drug hypersensitivity or allergic reactions, such as anaphylaxis 5) Individuals unable to comply with the study's essential requirements or procedures 6) Pregnant women, breastfeeding women, or individuals who may be pregnant or planning to become pregnant 7) Individuals deemed unsuitable by the principal investigator or sub-investigator 8) Individuals consuming Meiji Probio Yogurt R-1 four or more days per week 9) Individuals using systemic steroids, antibiotics, or probiotics Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 13 Day Date of IRB - 2025 Year 08 Month 28 Day Anticipated trial start date - 2025 Year 10 Month 27 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068009

Disclaimer: Curated by HT Syndication.