Study to confirm the effects of test food ingestion on brain activity

UMIN ID: UMIN000052067

Registered date:26/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2023/10/09
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Single ingestion of test food > washout period > single ingestion of placebo food.
Single ingestion of placebo food > washout period > single ingestion of test food.

Outcome(s)

• Primary Outcome: Evaluation of brain activity (objective and subjective evaluations)
• Secondary Outcome: Safety Assessment (adverse events and side effects)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 30years-old
• Gender: Male and Female
• Exclude criteria: Subjects who 1)fasting blood glucose of 126 mg/dL or higher 2)have chronic physical illness 3)have or are being treated for memory impairment disease symptoms such as dementia 4)have alcoholism or other mental disorders 5)currently have some kind of disease and are receiving drug treatment 6)have received any kind of drug treatment(except for a history of abortive medication such as headache, menstrual cramps, common cold, etc.)for one month prior to obtaining consent 7) have currently, or within the past 3 months, continuously using drugs that claim to maintain or enhance cognitive function 8)have currently, or within the past 3 months have been, or will be during the study period, continuously consuming functional foods, health foods, or supplements that claim to maintain or enhance cognitive function 9)have undergone medical treatment involving hospitalization within the past 6 months, or those who are scheduled to be hospitalized during the examination period 10)have current medical history or past medical history of serious disease in heart, liver, kidney, digestive organ 11)who have been diagnosed with iron deficiency anemia by a physician or determined to have iron deficiency anemia by medical examination or other means 12)may develop seasonal allergic symptoms such as hay fever during the study period 13) have food allergies (including a history of food allergies) (especially milk and gelatin) 14)Pregnant, lactating, or possibly pregnant, or planning to become pregnant during the study period 15)Subjects with smoking habit 16)may change their lifestyle during the study period (drastic change in club activities, long trips, etc.) 19)currently participating in another clinical trial, or one month has not passed since participation in another clinical trial 22)were judged ineligible for enrollment in the study by the principal investigator or sub-investigator

Related Information

• Primary Sponsor: R&D Institute Morinaga & Co., Ltd.
• Source(s) of Monetary Support: R&D Institute Morinaga & Co., Ltd.