healthy person
Conditions
Interventions
Secoisolariciresinol diglucoside (SDG) capsule (4 capsules per day)
Placebo capsule (4 capsules per day)
Sponsors
Macromill, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Females between the ages of 35-60 years at the time of consent. (2) Those who are able to consume the test meal continuously. (3) Those who are in the transitional period (irregular menstruation in the last year) or after menopause (less than 3 years from the last menstrual period). (4) Those who have subjective symptoms related to menopause (5) Simplified Menopausal Index (SMI): 26 points or more. (6) Those who can avoid binge drinking and excessive exercise during the study period and lead the same lifestyle (diet, exercise, etc.) as before the study period. (7) Those who have received sufficient explanation of the purpose and content of this study, have the ability to consent, and can voluntarily volunteer to participate with a good understanding of the study, and agree to participate in this study in writing. (8) Those who receive no medication.
Exclusion criteria
Exclusion criteria: (1) Those who have food allergy. (2) Those who are pregnant or lactating, or plan to become pregnant or lactate during the study. (3) Those who have participated in other clinical studies within 3 months of consent and those who plan to participate in other clinical studies during the study period. (4) Those who have undergone oophorectomy or hysterectomy. (5) Those with extremely irregular diets or sleep rhythms (e.g., Night and day shift worker). (6) Those who regularly use medicines, food for specified health use, functional food, or health food that may affect the evaluation items. (7) Those who have been taking hormone therapy. (8) Those who excessively smoke or excessively consume alcohol. (9) Those who are undergoing treatment for a disease, or have a history of a serious disease that required medication. (10) Patients with serious diseases such as diabetes, hepatic disease, renal disease, or cardiac disease, or those with a history of such diseases. (11) Those who are judged to be inappropriate as subjects based on the answers to various questionnaires. (12) Others, who are judged by the principal investigator to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The simplified menopausal index (SMI) test Pittsburgh sleep quality index | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires related to menopausal symptoms | — |
Countries
Japan
Contacts
Public ContactSoma Ode
Macromill, Inc. Secretariat "Evaluation test for menopausal symptom improvement by flax lignan"
Outcome results
None listed