None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 40 to 59 at the time of obtaining consent to participate in the trial. 2) Individuals who are aware of symptoms associated with menopause (irritability, anxiety, mood swings, etc.). 3) Individuals who have received sufficient explanation of the purpose and content of this trial, have the capacity to consent, understand it well, voluntarily volunteer to participate, and can give written consent to participate in this trial. 4) Individuals who can visit the facility on the designated examination date and undergo the examination.
Exclusion criteria
Exclusion criteria: Individuals 1) who are suffering from any disease and undergoing treatment. 2) with a history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or a history of serious diseases. 3) with a history of severe conditions such as liver, kidney, heart, lung, blood, digestive tract, respiratory, endocrine, metabolic, neurological, or consciousness disorders. 4) with severe anemia. 5) with a Simplified Menopause Index (SMI) of 51 points or higher. 6) with a CES-D Depression Self-Rating Scale score of 16 or higher (suspected depressive state). 7) who have a history of taking or applying medication for the treatment of a disease within the past month. 8) with a BMI of 30.0 kg/m2 or higher. 9) at risk of allergic reactions to components contained in the test food, as well as individuals at risk of allergic reactions to other foods or medications. 10) with a history of continuous consumption of specific health foods, functional foods, health supplements, or dietary supplements within the past three months, as well as individuals planning to consume such products during the trial period. 11) who have undergone placenta therapy within the past three months or currently undergoing such therapy. 12) whose daily alcohol consumption exceeds an average of 20 g/day of pure alcohol per week. 13) with irregular lifestyles, such as shift work or night work. 14) who may change their lifestyle during the trial period. 15) who have had 200 mL of blood drawn within one month prior to the start of the examination, or 400 mL or more within three months prior to the start of the examination. 16) currently participating in other human clinical trials, or individuals who have participated in other human clinical trials within the past three months. 17) who are pregnant, breastfeeding, or have the possibility of becoming pregnant, or who intend to become pregnant during the trial period. 18) Other individuals deemed inappropriate for this trial by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POMS2 Japanese Version (Full Item Version) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary evaluation items 1) Menopausal symptom evaluation form 2) OSA sleep questionnaire MA version 3) Questionnaire survey using the VAS method 4) Female hormone-related indicator tests 5) Bone marker-related indicator tests * Safety evaluation items 1) Physical examination 2) Clinical examination 3) Physician interview/evaluation of adverse events and side effects 4) Subject diary | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed