Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062163) titled 'Research on applying dashi to oral care to increase food intake' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Hirosaki Aiseikai Hospital, Takutoku Ishioka Ibusuki Takemoto Hospital, Daisuke Fukuyoshi Kanno Hospital, Akiko Wada Green Hills Wakakusa Hospital, Natsuko Shibahara

Condition: Condition - all-cause dementia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - As aged society is progressing rapidly, the number of elderly with dementia is increasing. As dementia progresses, physical assistance becomes necessary for various activities of daily living (ADL). Difficulty in eating independently leads to reduced food intake and diminished vitality, creating a vicious cycle of further decline in ADL. In many cases involving elderly with dementia, cognitive decline makes it difficult to recognize food, leading to a loss of appetite and reduced food intake. In these cases, we will apply dashi to oral care and investigate whether bonito dashi's stimulation of the sense of smell, taste, and physical stimulation of the oral cavity can increase food intake. This is a multicenter randomized controlled study. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Dashi group; Oral care is performed using a frozen oral care sponge impregnated with concentrated liquid dashi diluted fourfold. This regimen is continued for two weeks, and food intake is recorded. Interventions/Control_2 - Control group; Routine care.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Cases with dementia in which food intake over the past week decreased to 40% or less of the amount provided, based on an assessment by a registered dietitian. Key exclusion criteria - Cases with advanced dementia where conversation is difficult and communication is extremely challenging are excluded. Cases with severe physical complications (e.g., severe dysphagia, pneumonia, severe heart failure, chronic kidney disease stage G4 or higher, liver cirrhosis, severe ileus). If a subject in the dashi group develops pneumonia or a similar condition during the study period, their participation will be discontinued, and they will be excluded from the study. Cases where the individual refuses to consume dashi. Cases where consent could not be obtained from the individual or their family. Cases where allergies or similar conditions are suspected. Cases that participated in the "Research on increasing food intake by utilizing the dashi-flavor." Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 31 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071139

Disclaimer: Curated by HT Syndication.