None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly allocated to placebo or Tetragonia tetragonoides extract group and consume the assigned investigator food twice a day, each time 5 tablets for 12 weeks.
Sponsors
Ewha Womans University Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) The particioants who give informed consent before the start 2) 45~60 years old 3) Postmenopause (defined as at least 12 months amenorrhoea) or perimenopause (defined as having no more than one menstrual period during the 3 months before recruitment and having follicle stimulating hormone>40 IU/L) women 4) Women with moderate to severe menopausal symptoms (Kupperman index total score = 20)
Exclusion criteria
Exclusion criteria: 1) Subjects with surgical or chemotherapy induced menopause, a history of breast cancer or abnormal vaginalbleeding without diagnosis 2) Subjects who received hormone therapy within 6 months before the first visit 3) Subjects who consistently consumed the functional food related to postmenopause, bone health, blood glucose, blood lipid(cholesterol, triglyceride), blood pressure or blood flow within 1 month prior to the first visit 4) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant,selective estrogen receptor modulator, antihyperlipidemic agent, antihypertensive agent, antidiabetic agent, bisphosphonate or calcitonin 5) Subjects who have a history of endometrial hyperplasia, endometrial cancer, sex steroid dependant organ tumors 6) Subjects who have a history of severe migraine, thromboembolic disorders, cerebrovascular disorders, cardiovascular disease within 1 year prior to the first visit 7) Subjects with hepatic or renal dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 3 times the upper limit of normal, Creatinine > 2.0 mg/dL), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure > 140/90 mmHg), thyroid disease, diabetes or hyperlipidemia 8) drug addicts or alcoholics 9) Subjects who performed constant severe exercises at least 3 months prior to the first visit 10) Sensitive to test materials 11) Subjects who has participated in another clinical trial within 1 month prior to the first visit 12) Any condition that the principal investigator believes may put the subjects at undue risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Climacteric symptoms questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Markers of lipid metabolism ;Markers of bone metabolism ;Markers of safety, etc. | — |
Countries
Korea, Republic of
Contacts
Public ContactSunyoung Park
Ewha Womans University Medical Center
Outcome results
None listed