Study of effects on sleep by the intake of food for healthy subjects

UMIN ID: UMIN000056226

Registered date:21/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/11/23
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intake of test food for 4 consecutive weeks
Intake of placebo for 4 consecutive weeks

Outcome(s)

• Primary Outcome: OSA-MA
• Secondary Outcome: AIS, PSQI-J, POMS2-AS scores, serum DHEA-S, serum cortisol, the ratio of serum DHEA-S and serum cortisol

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: (1)Subjects who cannot eat one pack of test food every day (2)Subjects who have irregular sleeping environment, sleeping time and waking time on weekdays (3)Subjects who are a day shift worker or is involved in manual labor such as heavy object transportation and subjects whose working days and non- working days are irregular (4)Subjects who have difficulty in carrying out OSA-MA records (5)Subjects who are in the habit of consuming alcohol on a daily basis (6)Subjects who have environment that disturbs sleep (7)Subjects who have the disease requiring regular medication (8)Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome (9)Subjects who have or are suspected of having nocturia, benign prostatic hyperplasia, or an overactive bladder (10)Subjects who have history of mental illness, chronic fatigue syndrome, Hypertension, diabetes, or dyslipidemia (11)Subjects who are under treatment or have a history of serious diseases (e.g., liver disease, kidney disease, heart disease, lung disease, or blood disease) (12)Subjects who have possibilities for emerging allergy related to a food allergy (13)Subjects who have pollinosis that needs taking medicine (14)Subjects who Have a BMI of 30 or more (15)Subjects who have possibilities for changing lifestyle during the study period (16)Subjects who plan to become pregnant or breastfeed during the study period (17)Subjects who have participated in other human clinical trials, or subjects who have participated in other clinical trials within one month prior to obtaining consent to participate in this study (18)Subjects who are judged to be inappropriate as study subjects based on their answers to the lifestyle questionnaire (19)Subjects who are judged to be inappropriate as study subjects based on the results of the pre-test (20)Subjects deemed inappropriate as study subjects by the principal investigator or the investigator for other reason

Related Information

• Primary Sponsor: EP Mediate Co., Ltd.
• Source(s) of Monetary Support: Mizkan Holdings Co., Ltd.