Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062161) titled 'Research on increasing food intake by utilizing the dashi-flavor' 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. This study investigates whether stimulating the senses of smell and taste as well as providing physical oral stimulation using katsuo dashi (bonito soup stock) can increase food intake in such cases. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Dashi group; A concentrated liquid dashi, diluted fourfold and adjusted with a thickening agent to a medium viscosity of 225 mPa/s, is consumed before every meal, or at least twice daily, for examples before lunch and dinner. Continue for two weeks and keep a record of food intake. 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 resulting in significant difficulty with conversation and communication will be excluded. Cases with severe physical complications (e.g., severe dysphagia, pneumonia, severe heart failure, chronic kidney disease stage G4 or worse, liver cirrhosis, severe ileus). If a subject in the dashi group develops conditions such as pneumonia during the study period, their participation will be discontinued, and they will be excluded from the study. Cases where the subject refuses to consume the dashi. Cases where the subject consumes less than 15 mL of the dashi solution per meal. Cases where consent from the subject or their family cannot be obtained. Cases where allergies or similar conditions are suspected. Target Size - 40

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=R000071138

Disclaimer: Curated by HT Syndication.