Gut microbiota and activity of daily life to maitain cognitive functions

UMIN ID: UMIN000056087

Registered date:08/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: dementia
• Date of first enrollment: 2024/11/08
• Target sample size: 550
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Participants will consume a Bifidobacterium-containing food once daily for a period of 1 to 90 days.
Participants will consume a placebo once daily for a period of 1 to 90 days.

Outcome(s)

• Primary Outcome: Cognitive tasks using a tablet device, stool sample collection, and brain activity measurement with a handheld NIRS device (for those who wish to participate) will be conducted from one to a maximum of six times, at intervals of 30 or 90 days. Each cognitive task will be performed over two days per session. During breaks between tablet-based cognitive tasks, participants will complete the Japanese versions of the POMS Short Form and MoCA. Participants who consent to wearing a smart ring or smartwatch will wear the device as much as possible throughout the study period. Data will be provided via the participant's smartphone.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 99years-old
• Gender: Male and Female
• Exclude criteria: If operating a tablet device is difficult, if the participant is certified as requiring long-term care, or if they have been diagnosed with or are being treated for dementia or mild cognitive impairment.

Related Information

• Primary Sponsor: Waseda University
• Source(s) of Monetary Support: Waseda uNIversity