Menopause
Conditions
Brief summary
The aim of the study is to investigate effects of daily intake of Nordic Kudzu for 28 days in 5 groups of 10 menopausal women with symptoms. Groups:1) 3 capsules x3/day, 2) 3 capsules x2/day, 3) 2 capsules x3/day, 4) 2 capsules x2/day, 5) 3 capsules x1/day. Each capsule equal 1.26 g kudzu root extract. Outcome measures: Serum and urine levels of biochemical marker of bone-degradation, CTX-I, and symptoms of menopause using the Meopause Rating Scale (MRS).
Interventions
DIETARY_SUPPLEMENT3 caps x3/day
3 capsules 3 times daily for 28 days
DIETARY_SUPPLEMENT3 caps x2/day
3 capsules 2 times daily for 28 days
DIETARY_SUPPLEMENT2 caps x3/day
2 capsules 3 times daily for 28 days
DIETARY_SUPPLEMENT2 caps x2/day
2 capsules 2 times daily for 28 days
DIETARY_SUPPLEMENT3 caps x1/day
3 capsules 1 times daily for 28 days
Sponsors
Nordic Bioscience A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Unblinded, single-center, randomized, exploratory, dose-finding study. 1:1:1:1:1 randomisation to 5 groups of different doses for 28 days.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent 2. Women in the age between 45 and 60 years considered late peri- (defined as having had a menstrual period more than 3 months ago but less than 12 months ago) or postmenopausal (defined as at least 12 consecutive months without any menstrual flow) at the time of screening 3. Menopause symptoms, defined as a score of at least 5 in the Menopausal Rating Scale (MRS) at screening 4. Body Mass Index between 18 and 40 kg/m2 at the time of screening
Exclusion criteria
1. Allergy/hypersensitivity/intolerance to any components in the Kudzu herbal extract powder capsules 2. Past or present significant co-morbidity including, but not limited to: Uncontrolled, severe renal, hepatic, cardiovascular, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease 3. History of breast cancer or other malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ 4. Known history of clinically significant thromboembolism 5. Current alcohol abuse 6. Pregnancy, determined by positive serum human chorionic gonadotropin (hCG) test prior to randomization, except for women considered postmenopausal 7. Breastfeeding women 8. Participation in a study trial with any investigational new drug or food supplement within 3 months prior to the start of the study 9. Clinically significant ECG abnormalities, as judged by the investigator 10. Clinically significant biochemistry abnormalities including but not limited to ALT or AST \>2.5 x ULN or other clinically significant liver function parameters, as judged by the investigator 11. Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination 12. Use of local or systemic conventional hormone therapy regardless of indication or alternative medication including dietary supplements for the treatment of menopausal symptoms within 28 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause Rating Scale (MRS) | 28 days | Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms. |
| Serum CTX-I | 28 days | Blood based biomarker of bone resorption |
| Urine CTX-I | 28 days | Urine based biomarker of bone resorption |
Countries
Denmark
Outcome results
None listed