Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059923) titled 'Study on How an Edible Film Affects Saliva Production in Healthy Older Adults' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - chubu university

Condition: Condition - Healthy older adults (no specific disease) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the safety and usefulness of a newly developed edible film in 15 healthy older adults by confirming whether it can be ingested without causing a significant increase in salivary volume measured with an oral moisture meter, and by determining whether taste stimulation can be perceived through sensory evaluation. In addition, this study aims to examine whether emotional and facial expression changes induced by ingesting the edible film can be detected using an electroencephalogram (EEG) device and a facial expression analyzer. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Edible film: Participants ingest one sheet orally, followed by measurements of salivary volume, taste stimulation response, EEG activity, and facial expression changes. A total of four edible films will be used. The intervention will be conducted only once during the experimental session

Eligibility: Age-lower limit - 65 years-old

Gender - Male and Female Key inclusion criteria - 1. Individuals aged 65 years or older. 2. Individuals who correctly answered both items on the olfactory nerve test. 3. Individuals without any restriction of mouth opening. 4. Individuals with no olfactory dysfunction. Key exclusion criteria - 1. Individuals with restricted mouth opening. 2. Older adults with structural abnormalities of the oral cavity or upper gastrointestinal tract that make swallowing saliva difficult. 3. Individuals who have symptoms of a cold on the day of the experiment. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 08 Day Anticipated trial start date - 2026 Year 01 Month 26 Day Last follow-up date - 2026 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068512

Disclaimer: Curated by HT Syndication.