Dose-Finding Study of Food Products Containing Plant Extracts in Improving Sleep Distress

UMIN ID: UMIN000053909

Registered date:19/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: healthy person
• Date of first enrollment: 2024/03/19
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A: 200 mg of the test food every day after breakfast.
Group B: 400 mg of the test food every day after breakfast.

Outcome(s)

• Primary Outcome: The average values of the parameters related to the quantity and quality of sleep obtained from the results of EEG sleep measurements for each subject are calculated for each of the two nights before and after the intake of the test food, and these average values are used to evaluate the relationship between the intake of the test food and the dose.
• Secondary Outcome: The relationship between the presence and absence and dose of the test food intake will be evaluated by comparing each subject's Epworth Sleepiness Scale Questionnaire scores before and after two doses of the test food intake. In addition, the mean values of the subjective sleep quality parameters scored on the MA version of the OSA Sleep Questionnaire will be calculated for the two days before and after ingestion, respectively, and the relationship between the presence and absence of test food intake and dose will be evaluated by comparing these mean values. Each subject's scores on each of the Health Related Quality of Life Scale (SF-8), Fatigue Rating Scale (CFS), Overall Mood State (POMS2), and Depressed Mood Rating Questionnaire will be compared before and after consumption of the test food and two doses to evaluate the relationship between the test food intake and the dose.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 60years-old
• Gender: Male
• Exclude criteria: 1. Those who are currently receiving treatment (including medication) for any disease. 2. Those who have been diagnosed with sleep disorders such as insomnia or sleep apnea, and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs), or are receiving treatment with CPAP or mouthpieces, etc. 3. Those who have been diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, or nocturia. 4. Consume foods for specified health use, foods with functional claims, or other foods/beverages with possible functional properties on a regular basis. 5. Those whose BMI exceeds 30 (severely obese) 6. Those who are mainly in charge of taking care of those who need nursing care or infants. 7. Those who work late at night, shift work, or heavy labor. 8. Pregnant, lactating, or intending to become pregnant. 9. Those who cannot sleep alone on one bedding (futon or bed, etc.) during the examination period. 10. Those who sleep less than 6 hours (calculated based on their reported normal sleeping and waking times). 11. Those who are not able to comply with the gentle sleep control (going to bed within +-2 hours and waking up within +-2 hours) during the examination period, or those who are not sleeping regularly. 12. Persons who cannot avoid drinking alcohol and consuming caffeinated beverages (sencha, black tea, coffee, caffeinated beverages, etc.) after 6 p.m. during the EEG measurement period and the day before the measurement period. 13. Consumers who constantly drink more than the appropriate amount of alcohol (average daily alcohol consumption of approximately 20 g of pure alcohol or less*). Items that cannot be listed in the Exclusion Criteria column are listed in Other Relevant Items.

Related Information

• Primary Sponsor: Clinical Creative Co., Ltd.
• Source(s) of Monetary Support: DELIGHTEX PTE. LTD.