Confirmation of the effects of food intake on cognitive function in healthy subjects

UMIN ID: UMIN000056072

Registered date:17/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/11/18
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

One packet (30.0 g as solids) of the test food is dissolved in the prescribed amount of water (120 mL) and taken at once
One packet (30.0 g of solids) of placebo is dissolved in the prescribed amount of water (120 mL) and taken at once

Outcome(s)

• Primary Outcome: cognitive function tests (Cognitrax long)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude criteria: (1) Those who have a habit of drinking alcohol on a daily basis (40 g or more of alcohol equivalent/day), and those who have lifestyle habits that interfere with evaluation, such as irregular sleep schedule. (2) Those who are judged to be unsuitable as subjects based on the results of the pre-examination (3) Those who are prescribed or regularly use medications that may affect cognitive function (4) Those who consume health foods such as specified health foods and functional foods related to cognitive function at least one day per week (5) Those who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study (6) Those who may develop allergies in relation to the study, those who are at risk of developing seasonal allergies such as hay fever during the research period (7) Those who have a disease that requires constant medication, those who have a disease under treatment, who have symptoms of memory impairment such as dementia or sleep disorders, or who are undergoing treatment those who have a history of serious disease that required medication (8) Those whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range (9) Those who work in shifts, work late at night, and have an irregular daily rhythm (10) Those who are participating in the other study within one month prior to the start of this study (11) Those who plan to become pregnant or breastfeed during the study period (12) Those who have a smoking habit (13) Those who are not good at blood sampling tests or those who have difficulty collecting blood (14) Those who are judged to be unsuitable as subjects based on the answers to the background survey (15) Those who are judged as unsuitable for the study by the investigator for other reason

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: NIHON SHOKUHIN KAKO CO., LTD.