Clinical Trial: Study on the synergistic effects of oral intake of ferulic acid and gamma-oryzanol from rice bran components and an exercise program on cognitive function in older adults (Japan)

Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061111) titled 'Effects of ferulic acid, gamma-oryzanol, and an exercise program on cognitive function in healthy older adults' on April 1.

Study Type: Interventional

Study Design: Basic Design - Factorial Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Wakayama University

Condition: Condition - Age-related decline in cognitive function and health maintenance in healthy older adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to examine whether intake of ferulic acid and gamma-oryzanol, together with participation in an exercise program, can maintain or improve cognitive function, health status, and physical fitness in older adults. Participants will also be followed 6 months after the end of intake to evaluate the persistence of the effects. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Arm A: Non-exercise plus placebo capsule group. Participants orally take 4 placebo soft capsules daily for 12 weeks. No specific exercise program is provided, and participants continue their usual daily life. Interventions/Control_2 - Arm B: Non-exercise plus active capsule group. Participants orally take 4 active soft capsules daily for 12 weeks. The active capsules contain ferulic acid 300 mg/day and rice germ oil GX-N 150 mg/day, corresponding to approximately 45 mg/day of gamma-oryzanol. No specific exercise program is provided, and participants continue their usual daily life.

Eligibility: Age-lower limit - 60 years-old = Gender - Male and Female Key inclusion criteria - 1. Healthy men and women aged 60 to 84 years 2. Individuals judged healthy based on a medical interview or examination by a physician 3. Individuals not using medications or supplements expected to influence the study outcomes 4. Individuals who receive a full explanation of the study, understand the study, and can provide written informed consent 5. Individuals who are able to attend the scheduled visits and undergo the required assessments 6. Individuals judged eligible for participation by a physician Key exclusion criteria - 1. Individuals judged unsuitable for participation by a physician 2. Individuals unable to attend the scheduled visits 3. Individuals using medications or supplements expected to influence the study outcomes 4. Individuals unable to understand the study or provide written informed consent 5. Individuals not cleared for participation in the exercise component based on the pre-study medical check-up Target Size - 200

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 04 Month 15 Day Date of IRB - 2025 Year 04 Month 15 Day Anticipated trial start date - 2025 Year 06 Month 01 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=R000069932

Disclaimer: Curated by HT Syndication.