2.2. Study Design of Trial 2
memory complaints, dementia
COVID-19 INFECTION
A randomized, double-blind, placebo-controlled, parallel-group trial was designed to perform a confirmatory evaluation of the effect of supplementation with LCPUFAs + LZ on memory function in healthy older Japanese individuals with memory complaints without dementia. This trial was conducted between August 2021 and October 2022 at medical institutions in Meguro-ku, Tokyo, and in Osaka-shi, Osaka, Japan. A total of 254 participants were recruited from Tokyo, Osaka, and neighboring regions, of whom 192 were enrolled and randomly allocated to two groups: (1) a placebo group, receiving a placebo as a food supplement; (2) an LCPUFAs + LZ group, receiving a food supplement consisting of LCPUFAs (containing 120 mg ARA, 300 mg DHA, and 100 mg EPA per day) combined with LZ (containing 10 mg lutein and 2 mg zeaxanthin per day). The intervention period was set at 12 weeks, because efficacy was found to be exploratory at 12 weeks in Trial 1. Screening and outcome assessments were performed similarly to those in Trial 1, except that they were performed in a remote environment and blood samples were only collected during screening to avoid the risk of COVID-19 infection. The Medical Station Clinic Research Ethics Committee confirmed the principles outlined in the Declaration of Helsinki and approved the protocol (#210708-1). This trial was registered in the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN000044844) on 13 July 2021. Written informed consent was obtained from all the participants. This report follows the Consolidated Standards of Reporting Trials (CONSORT) statement [