None listed
Conditions
Interventions
Dietary Supplement : Subjects were randomly allocated at placebo group, placebo plus exercise group, combination of kudzu and foxglove root extract groups (low group and high group), combination of ku
Sponsors
Ewha Womans University
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) 5) Fasting LDL-cholesterol level = 130mg/dL 6) Women with low quality of the meal (recommended food score = 36) 7) Fasting blood glucose = 100 mg/dl 8) glycated hemoglobin (HbA1c) = 5.7% and = 6.4% 9) BMI: = 23kg/m2
Exclusion criteria
Exclusion criteria: 1) Subjects who performed constant exercises at least 3 months prior to the first visit 2) Subjects who cannot participate in an exercise program 3) Subjects with surgical or chemotherapy induced menopause 4) Subjects who have a history of breast cancer orabnormality depicted on a mammogram5) Subjects who received hormone therapy within 6 months before the first visit 6) Subjects who take excessive amount of isoflavones (=56 mg/day) 7) Subjects who consumed the functional food within 4 weeks prior to the first visit 8) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant,selective estrogen receptor modulator, hypocholesterolemic drug, antihypertensive drugs, antidiabetes drugs, bisphosphonate, calcitonin 9) Subjects who have been vaginal bleeding without diagnosis 10) Subjects who have a history of endometrial hyperplasia, endometrial cancer, sex steroid dependant organ tumors 11) Subjects who have a history of severe migraine, thromboembolism, cerebrovascular disease, cardiovascular disease within 1 year prior to the first visit 12) Subjects with hepatic or renal dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times the upper limit of normal, Creatinine > 2.0 mg/dL) 13) Hypertensive subjects Systolic blood pressure(SBP)/Diastolic blood pressure(DBP) = 140/90 mmHg), subjects with thyroid disease (thyroid stimulating hormone(TSH)4.78uIU/mL), diabetes, subjects with hyperlipidemia 14) drug addicts or alcoholics 15) Subjects sensitive to test materials 16) Subjects who has participated in another investigational study within 4 weeks prior to the first visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Climacteric symptoms questionnaire ; vascular biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid metabolism profiles;inflammation biomarkers | — |
Countries
Korea, Republic of
Contacts
Public ContactHyangmok Ok
Ewha Womans University
Outcome results
None listed