Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062376) titled 'A study evaluating the effects of test foods on immunosenescent cells' on July 29.

Study Type: Interventional

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

Primary Sponsor: Institute - APO PLUS STATION CO., LTD.

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

Objective: Narrative objectives1 - To investigate the effects of the test food on immunosenescent cells Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Ingestion of the test food for 12 consecutive weeks Interventions/Control_2 - Ingestion of placebo for 12 consecutive weeks

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1)Japanese males and females aged 40 to under 65 at the time of informed consent. 2)Participants with advanced immunosenescence. 3)Participants who received a full explanation of the study and signed the informed consent form before study initiation. Key exclusion criteria - 1) Participants with a history of gastrointestinal resection surgery (excluding appendectomy). 2) Participants with a serious disease under treatment, or a history of a serious disease requiring pharmacological treatment. 3) Participants with autoimmune diseases (e.g., Graves' disease, rheumatoid arthritis, Hashimoto's thyroiditis, type 1 diabetes mellitus, systemic lupus erythematosus, polymyositis, Sjogren's syndrome, and systemic sclerosis), or a history thereof. 4) Participants with psychiatric disorders (e.g., depression), chronic fatigue syndrome, insomnia, or a history thereof. 5) Participants engaged in irregular work schedules, shift work, or physically demanding labor. 6) Participants regularly using medications, FOSHU, dietary supplements, or other health foods that may affect study outcomes. 7) Participants considered at risk of allergic reactions related to the study. 8) Participants with excessive alcohol consumption (average pure alcohol intake >=60 g/day) or current smokers. 9) Participants planning overseas travel or domestic travel lasting >=1 week during the study period. 10) Participants who participated in another clinical trial or research study within 3 months before informed consent, or who plan to participate in another study during the study period. 11) Participants who donated >200 mL of whole blood within 1 month before informed consent, or >400 mL of whole blood and/or blood components within 3 months before informed consent. 12) Participants who are pregnant, breastfeeding, or may become pregnant during the study period. 13) Participants considered unlikely to comply with study procedures, questionnaires, or study records. 14) Participants judged unsuitable based on clinical laboratory values or other screening results. 15) Participants suspected of having an infectious disease based on screening results, including HBV, HCV, syphilis, HTLV, or HIV infection. 16) Other participants judged unsuitable by the investigator. Target Size - 46

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 26 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 29 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=R000071318

Disclaimer: Curated by HT Syndication.