Tokyo, Aug. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062635) titled 'An exploratory study of the anti-aging effects of test foods: an open-label, randomized, parallel-group comparative trial' on Aug. 21.

Study Type: Interventional

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

Primary Sponsor: Institute - Kirin Holdings Company, Limited

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The study aims to clarify age-related physiological changes and evaluate the potential anti-aging effects of the test foods. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous intake of test food 1 for 8 weeks (older participants) Interventions/Control_2 - Continuous intake of test food 2 for 8 weeks (older participants)

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Individuals aged 20 to = 18.5 kg/m^2. (4) Able to complete electronic questionnaires and diaries using a smartphone or personal computer (PC). (5) Individuals who voluntarily agreed to participate and provided written informed consent after receiving and fully understanding and explanation of the purpose and procedures of the study. Key exclusion criteria - (1) Current or previous immune-related diseases or other serious medical conditions. (2) Diagnosis of dry mouth (xerostomia). (3) Currently receiving dietary therapy or exercise therapy under the supervision of a physician. (4) Routine consumption (>= 3 times per week) of foods for specified health uses, foods with function claims, dietary supplements containing lactic acid bacteria or bifidobacteria, or other foods or dietary supplements claiming to maintain immune function. (5) Known allergy to the test food (older adults only). (6) Planned use during the study period of medications that may affect immune function or the intestinal environment, including antihistamines, antibiotics, intestinal regulators, laxatives, NSAIDs (e.g., loxoprofen and celecoxib), corticosteroids, leukotriene receptor antagonists, PPIs, or hypnotics. (7) Scheduled to undergo endoscopy, barium gastrointestinal examination, Helicobacter pylori eradication therapy, tooth extraction, ophthalmic surgery, endoscopic procedures, or any other invasive surgery or medical procedure during the study period. (8) Excessive alcohol consumption (defined as an average daily intake of >= 40 g of pure alcohol). (9) Excessive smoking (defined as >= 21 cigarettes per day). (10) Engagement in shift work involving night shifts. (11) Planned major changes in lifestyle during the study period, including diet, use of health foods or dietary supplements, medications, sleep habits, or physical activity. (12) Planned overseas travel during the study period. (13) Pregnant, breastfeeding, or planning to become pregnant during the study period (younger adults only). (14) Participation in another clinical study within 1 month before providing informed consent, current participation in another clinical study, or planned participation in another clinical study during the study period. (15) Planned vaccination during the study period. (16) Deemed unsuitable for participation in the study by the principal investigator. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 29 Day Date of IRB - 2026 Year 07 Month 29 Day Anticipated trial start date - 2026 Year 08 Month 22 Day Last follow-up date - 2026 Year 12 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071667

Disclaimer: Curated by HT Syndication.