Verification of the efficacy of test foods intake in VDT work in healthy adults.

UMIN ID: UMIN000054264

Registered date:26/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2024/05/13
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A single administration of the test food is performed. After a washout period, a single administration of placebo is performed.
A single administration of the placebo is performed. After a washout period, a single administration of test food is performed.

Outcome(s)

• Primary Outcome: subjective evaluation(POMS2,VAS)
• Secondary Outcome: EEG, scores associated with VDT tasks

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: a. taking medication or under medical treatment b. pregnant, lactating, or intending to become pregnant during the study period c. Minors (under 18 years of age) d. under exercise therapy or dietetic therapy e. allergic to test food f. current dependence or history of either medicine or alcohol dependence syndrome g. current or prior diagnosis of mental illness (depression) or sleep disturbance h. extremely irregular lifestyle i. on a night-shift or shift worker j. unbalanced diet k. current disease or history of brain disease, malignant tumor, immunological disease, diabetes, renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic disease. l. use of health foods, supplements, and medicines m. participation in other clinical studies within the past 3 months from the day of consent or planning to participate in other clinical studies during the current study; n. considered as an inappropriate candidate by the doctor in charge.

Related Information

• Primary Sponsor: Pharama Foods International Co., Ltd.
• Source(s) of Monetary Support: Pharama Foods International Co., Ltd.