Tokyo, April 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061109) titled 'Preliminary study on the effects of a lactic acid drink on cognitive performance, sleep, fatigue, and gastrointestinal symptoms' on April 6.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Institute of Community Life Sciences Co., Ltd.

Condition: Condition - Subjective sleep problems Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of daily intake of a lactic acid drink on sleep and related cognitive performance in older adults, and to exploratorily assess perceived fatigue and gastrointestinal symptoms. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will consume 100 mL of a lactic acid drink daily for 12 weeks.

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (1) Individuals who are able to attend the regularly scheduled measurement sessions. (2) Individuals aged 60 years or older at the time of informed consent. (3) Individuals who perceive that they have sleep problems, such as difficulty falling asleep after going to bed, shallow sleep, or frequent awakenings during the night. (4) Individuals who have the capacity to provide consent, have received a sufficient explanation of the purpose and procedures of the study, fully understand the information provided, and voluntarily agree to participate by signing the written informed consent form. Key exclusion criteria - (1) Individuals who have participated in another clinical study within the past three months prior to providing informed consent. (2) Individuals who habitually consume yogurt or lactic acid drinks four or more days per week. (3) Individuals with allergies to milk or soy. (4) Individuals currently undergoing treatment for diabetes. (5) Individuals who are otherwise judged to be ineligible by the principal investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 21 Day Date of IRB - 2026 Year 01 Month 21 Day Anticipated trial start date - 2026 Year 04 Month 07 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069907

Disclaimer: Curated by HT Syndication.