Healthy subjects
Conditions
Interventions
Consume the test food for 4 weeks, followed by the placebo food for another 4 weeks
Consume the placebo food for 4 weeks, followed by the test food for another 4 weeks
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female adults aged 20 years or older and under 65 years at the time of obtaining informed consent 2. Individuals who report dissatisfaction with their sleep 3. Individuals who sleep alone at bedtime 4. Individuals who have been informed of the purpose and details of the study, possess the capacity to provide consent, thoroughly understand the information, and voluntarily provide their consent via electronic informed consent
Exclusion criteria
Exclusion criteria: Individuals: 1.With sleep or psychiatric disorders under treatment or with a history of severe illness 2.With chronic diseases under medical treatment 3.With a history of or receiving treatment for serious cardiovascular, cerebrovascular, hepatic, renal, hematologic, or endocrine disorders 4.With gastrointestinal disorders under treatment or with a history of severe illness 5.With significant abnormalities in vitals, blood tests, or physical examination during the pre-screening 6.With past adverse reactions after blood collection 7.Suspected of having allergic reactions to the test food 8.With pacemakers or implantable cardioverter defibrillators 9.With a history of skin problems caused by alcohol disinfectants or adhesive tapes 10.Experiencing nocturia 11.Who may have blood contamination in their saliva samples 12.Who have recently donated blood or cannot refrain from donating blood during the study period 13.Regularly using medications, specified health foods, or nutraceuticals that may improve or inhibit sleepiness before bedtime 14.Regularly using medications that may affect bowel movements 15.Regularly consuming specific health foods (other than those affecting sleepiness) and who cannot discontinue these during the study period 16.Regularly consuming fermented milk or probiotic beverages and who cannot discontinue intake during the study period 17-19.Regular alcohol consumers, current smokers or those who have quit within the past 3 months, and those with irregular sleep or eating habits 20.Expected to undergo significant changes in living environment, dietary habits, or exercise routines during the study period 21.Women who are breastfeeding, pregnant, possibly pregnant, or intending to become pregnant during the study period 22.Currently participating in other clinical trials, participated within the past 4 weeks, or planning to participate during the study period 23.Deemed ineligible by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Sleep Parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Karolinska Sleepiness Scale (KSS) (2) Visual Analogue Scale (VAS) Questionnaire (3) State-Trait Anxiety Inventory (STAI) (4) Snoring Parameters (5) Gut Microbiota in Fecal Samples (6) Short-Chain Fatty Acids in Fecal Samples (7) Salivary Stress Markers (8) Inflammatory Markers in Blood (9)Biometric Data Collected via Wearable Devices (10)Stool Frequency and Consistency | — |
Countries
Japan
Contacts
Public ContactAyumi Sugioka
Macromill, Inc. Clinical Trial Unit, Life Science Division
Outcome results
None listed