Healthy subjects
Conditions
Interventions
8-week intake of the probiotics food
8-week intake of the placebo food
Sponsors
Morinaga Milk Industry Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age at least 20 but less than 65 years old at the time of informed consent 2) Those whose global score of PSQI-J at the time of the screening test is between 6 and 10 points 3) Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1) Those with serious medical complications or those suffering from illnesses that require urgent treatment. 2) A history of drug allergy or food allergy 3) Those who have chronic diseases (except PMS and menopausal disorders) and are regular users of medications. 4) Persons with gastrointestinal diseases affecting digestion and absorption, and a history of gastrointestinal surgery (except appendicitis). 5) Those with a history or current history of insomnia, psychiatric disorders, drug dependence, or alcohol dependence. 6) Have a history of sleep apnea (including those being treated with CPAP) 7) Those currently undergoing treatment or using medications related to sleep, stress, or fatigue 8) Those who are unable to discontinue the intake of foods or supplements with health functions, probiotics, or prebiotics during the study period. 9) Those who cannot stop consuming caffeine-rich foods and drinks after 3:00 p.m. during the test period. 10) Excessive alcohol drinker or excessive smokers 11) Frequent nocturia (more than 3 interruptions of sleep due to urination) 12) Those who plan to use drugs due to hay fever or allergic rhinitis 13) Those who do not have a fixed work schedule per week. 14) Pregnant women, intending mothers, and lactating mothers 15) Those who had a blood draw of 400 mL or more within 12 weeks prior to the start of intake, or 200 mL or more during the previous observation period. 16) Persons with sensitive skin who may develop skin irritation due to adhesive plasters or tapes. 17) Those who plan to travel abroad during the test period. 18) Participated, or is participating, or intends to participate, in any other study within the past 12 weeks. 19) BMI greater than or equal to 30 at the time of screening test 20) Persons who test positive for infectious diseases at the time of screening test. 21) Subjects who are judged by the investigator or sub-investigator to be unsuitable for the study based on the results of clinical examinations, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version | — |
Secondary
| Measure | Time frame |
|---|---|
| PSQI-J, AIS, POMS2, Salivary cortisol | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed