A pilot study to confirm the effect of test foods on sleep quality

UMIN ID: UMIN000056567

Registered date:11/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healty volunteers
• Date of first enrollment: 2025/01/12
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral intake of test food for 4 weeks

Outcome(s)

• Primary Outcome: pittsburgh sleep quality index(PSQI)
• Secondary Outcome: Daily Record of Severity of Problems(DRSP) Fatigue Visual Analog Scale Body composition measurement Skin condition Fitbit Sleep Profiles Blood growth hormone concentration

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 55years-old
• Gender: Female
• Exclude criteria: 1) Those who have been taking medicines regularly within the last 3 months prior to the start of the study (excluding temporary medications such as painkillers and cold medicines) 2) Those with serious illnesses (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illnesses 3) Those with a history of serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or digestive system disease 4) Those who have regularly taken specific health foods, functional foods, health foods (including supplements), etc., that may affect the study, at least three times a week within three months prior to the start of the study. 5) Those who cannot stop taking foods for specified health uses, foods with functional claims, health foods (including supplements), etc. that may affect the study during the study period. 6) Those whose menstruation has stopped completely 7) Those who are pregnant or breastfeeding, or who plan to or wish to do so during the study period 8) Those who live in an environment where sleep is disturbed by factors other than themselves, such as living with infants or people who require care 9) Those who drink a lot of alcohol (40g or more of pure alcohol per day on average) 10) Those with extremely irregular eating habits or those with irregular lifestyles such as working night shifts 11) Those with drug or food allergies 12) Participants in clinical trials related to sleep quality or PMS within 6 months of the start of the study 13) Those who are currently participating in another clinical trial, have completed a clinical trial within the last 4 weeks, or are scheduled to participate in another clinical trial while participating in this study. 14) Those who are deemed ineligible to participate in this study by the investigator

Related Information

• Primary Sponsor: MITSUBISHI GAS CHEMICAL COMPANY, INC.
• Source(s) of Monetary Support: MITSUBISHI GAS CHEMICAL COMPANY, INC.