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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 10 subjects |
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| Group 2 | Active Comparator | 10 subjects |
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| Group 3 | Active Comparator | 10 subjects |
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| Group 4 | Active Comparator | 10 subjects |
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| Group 5 | Active Comparator | 10 subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 caps x3/day | Dietary Supplement | 3 capsules 3 times daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause Rating Scale (MRS) | Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms. | 28 days |
| Serum CTX-I | Blood based biomarker of bone resorption | 28 days |
| Urine CTX-I | Urine based biomarker of bone resorption | 28 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning B Nielsen, DMSci | Sanos Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanos Clinic | Herlev | 2730 | Denmark |
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Unblinded, single-center, randomized, exploratory, dose-finding study. 1:1:1:1:1 randomisation to 5 groups of different doses for 28 days.
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| 3 caps x2/day |
| Dietary Supplement |
3 capsules 2 times daily for 28 days |
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| 2 caps x3/day | Dietary Supplement | 2 capsules 3 times daily for 28 days |
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| 2 caps x2/day | Dietary Supplement | 2 capsules 2 times daily for 28 days |
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| 3 caps x1/day | Dietary Supplement | 3 capsules 1 times daily for 28 days |
|