None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly allocated to placebo or rice bran extract group and consume the assigned investigator food once a day, 3 capsules for 12 weeks.
Sponsors
S&D
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subject who agrees to participate in the study and signs the informed consent form 2) Women aged 45–65 years 3) Post-menopausal (amenorrhea = 12 months) or peri-menopausal (amenorrhea = 3 month & follicle stimulating hormone (FSH) > 30 IU/L) 4) Moderate or severe menopausal symptoms (score = 15), identified by the Kupperman index
Exclusion criteria
Exclusion criteria: 1) Subjects with surgical or chemotherapy induced menopause, Subjects who have been vaginal bleeding without diagnosis 2) Hormone therapy within the past 6 months prior to the first visit 3) Subjects who consumed the functional food or oriental medicine that can affect menopausal health, blood glucose, blood lipids (triglycerides, cholesterol, etc.), blood pressure, blood circulation within 4 weeks prior to the first visit 4) Use of medication within the past 4 weeks: sleep-inducing agents, antidepressants, selective estrogen receptor modulators, antihyperlipidemic drugs, antihypertensive drugs, beta-blockers, antidiabetic drugs. However, in the case of beta-blockers, they may be included in the subject if they are expected to have no change of taking dose for one year or have no change of taking dose during the study. 5) History of breast cancer, endometrial hyperplasia, uterine endometrial cancer, and sex steroid dependent organ tumors or subjects with clinically significant abnormality in thyroid function test, mammography, or pelvic ultrasound 6) Abnormality in renal and liver function (eGFR < 60; ALT or AST > the upper limit of normal levels x 2.5), uncontrolled hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) >160/100 mmHg), thyroid disease, diabetes mellitus, hyperlipidemia 7) History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular conditions within 1 year 8) Beck Depression Inventory score =13, = 29 9) History of drug abuse, or alcoholism 10) Subjects who performed continuous high-intensity exercises at least 3 months prior to the first visit (=10 hours/week) 11) Allergy (hypersensitivity) to any of the materials used in the study 12) Subject who participated in other clinical trial within 1 month 13) Other cases considered inappropriate for the clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman index | — |
Secondary
| Measure | Time frame |
|---|---|
| Climacteric symptoms questionnaire;Markers of lipid metabolism;Anthropometric markers;Safety markers | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Eun Kim
Konkuk University Medical Center
Outcome results
None listed