Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062466) titled 'Demonstration experiment on MCI and frailty countermeasures using ingredients from Kyushu' on Aug. 4.

Study Type: Interventional

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

Primary Sponsor: Institute - Saishunkan Pharmaceutical Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To objectively evaluate changes in cognitive function scores, physical and daily function (frailty) scores, and blood protein profiles (proteomics analysis) before and after intervention in senior citizens who are aware of a decline in their own cognitive and physical functions, by having them ingest tablet-shaped test foods containing Kyushu-derived functional ingredients for a certain period. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Test Group A: Daily intake of the control diet (dextrin tablets) for 4 months. Interventions/Control_2 - Test Group B: Daily intake of the test diet (supplement containing Tamogidake) for 4 months.

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate. 2. Japanese persons who are 60 years old or more at the time of obtaining consent. 3. Persons who can come to the measurement site. Key exclusion criteria - 1. Persons who are diagnosed with dementia. 2. Persons who currently have malignant tumors (cancer) under treatment, severe heart failure/respiratory disease, chronic kidney disease requiring dialysis, or severe autoimmune disease. 3. Persons who take either diabetes medication or immunosuppressive agents. 4. Persons who have obvious paralysis due to sequelae of cerebrovascular disease (such as stroke), or have neurodegenerative diseases such as Parkinson's disease. 5. Persons who have physical difficulty in walking or measuring grip strength due to acute fractures or joint diseases. 6. Persons who have participated in other studies within 1 month before the start of the study, or who plan to participate in another study after consenting to this study. 7. Persons who are judged as inappropriate for study participants by the principal investigator. 8. Persons who are pregnant or breastfeeding. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 10 Day Date of IRB - 2026 Year 07 Month 28 Day Anticipated trial start date - 2026 Year 08 Month 10 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071496

Disclaimer: Curated by HT Syndication.