Tokyo, Oct. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063245) titled 'Effects of a dairy ingredient on the oral environment in healthy individuals : a randomized, double-blind, placebo-controlled, crossover superiority trial' on Oct. 12.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyushu University of Medical Science

Condition: Condition - None (Healthy individuals) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effect of a dairy ingredient on the oral environment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - A single intake of dairy ingredient. Interventions/Control_2 - A single intake of placebo.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Individuals aged 18 to 65 years. Key exclusion criteria - 1)Individuals with diseases of the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system requiring treatment, those with chronic diseases requiring treatment, or those with a history of any serious disease affecting these organs or systems. 2)Individuals who have oral or dental diseases or are receiving treatment for such conditions. 3)Individuals wearing dentures, dental implants, bridges, orthodontic appliances, or other intraoral devices. 4)Individuals who have dysphagia or are suspected of having dysphagia. 5)Individuals who work shifts or are unable to obtain adequate sleep at night for other reasons. 6)Individuals who are unable to discontinue the use of medications or health foods that may affect the oral environment during the study period. 7)Individuals who are unable to refrain from undergoing aesthetic or preventive dental procedures during the study period. 8)Smoker. 9)Extremely heavy drinkers (more than 60g/day of alcohol). 10)Individuals with serious allergies to foods, including milk, or to medications, or those with a history of such allergies. 11)Individuals who are pregnant or under lactation, or who is expected to be pregnant during the study. 12)Individuals who are judged by the principal investigator or principal dentist to be unsuitable for participation in the study based on their background or other relevant considerations. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 12 Day Date of IRB - 2026 Year 10 Month 12 Day Anticipated trial start date - 2026 Year 10 Month 13 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072392

Disclaimer: Curated by HT Syndication.