Healthy Adult
Conditions
Interventions
Intake of tablets containing lactic acid bacteria for 12 weeks
Intake of placebo tablets for 12 weeks
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Healthy women aged 45 to 69 years old at the time of consent for the clinical trial 2.Subjects who experience stress in their daily lives 3.Subjects with relatively high TMD score (T score) of the POMS-2 short form for adults 4.Subjects who have been informed about the purpose and details of the study, possess the capacity to consent, understand the information thoroughly, and can provide informed consent electronically
Exclusion criteria
Exclusion criteria: 1.Subjects currently receiving medical treatment for gynecological, thyroid, autonomic nervous system, or mental disorders, or those planning to during the study 2.Subjects currently taking medication that affects menopausal symptoms 3.Subjects who have undergone oophorectomy or hysterectomy 4.Subjects who have previously received hormone replacement therapy 5.Subjects currently receiving medical treatment for chronic diseases 6.Subjects being treated for malignant tumors, or cerebrovascular, heart, liver, kidney, blood, or endocrine disorders, or those with a serious medical history in these areas 7.Subjects receiving treatment for digestive diseases, or those with a significant medical history in these areas (excluding appendectomy) 8.Subjects with significant abnormalities in vital signs, blood, or physical tests 9.Subjects suspected of having HBV, HCV, syphilis, or HIV 10.Subjects who have felt unwell or experienced a decline in physical condition due to blood sampling 11.Subjects who have recently donated blood or cannot refrain during the study 12.Women who are breastfeeding, pregnant, possibly pregnant, or planning to become pregnant during the study 13.Subjects suspected of having a mental disorder based on the SDS score at web screening and medical interview 14.Subjects with SMI score of >= 51 at the web screening 15.Subjects who regularly consume functional foods and cannot stop during the study 16.Subjects who regularly consume foods containing the same component as the test food 17.Subjects who may have blood contamination in their saliva sample 18.Subjects with allergies to the test food 19-21.Heavy smokers, regular alcohol consumers, extremely irregular eating habits 22.Subjects expecting significant changes in their living environment, diet, and exercise habits during the study 23.Subjects in other trials within 4 weeks or planning to join others during the study 24.Subjects deemed ineligible by the principal medical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS-2 Adult Short Version | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) SMI 2) OSA sleep inventory MA version 3) Visual Analog Scale - Fatigue 4) Female hormones in the blood (E2, FSH, LH, P4) 5) Stress-related markers in the blood 6) Salivary cortisol 7) Stool frequency, stool shape, stool volume, feeling of incomplete defecation | — |
Countries
Japan
Contacts
Public ContactAya Takahashi
Macromill, Inc. Life Science Division, Clinical Research Unit
Outcome results
None listed