A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism

Study Overview
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Brief Summary
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Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing effects. However, no investigation has been conducted on the effect of polycan on bone health in perimenopausal women. Therefore, in this study, we investigated the effect of polycan on biochemical markers of bone metabolism in Korean perimenopausal women.

Official Title
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Efficacy and Safety Study of Polycan on Bone Metabolism

Conditions
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Bone Health in Perimenopausal Women

Intervention / Treatment
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* Dietary Supplement: Polycan
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine). Perimenopausal women : aged 40-70 Exclusion Criteria: Women with a body mass index (BMI) >30 kg/m2 or who were being treated with estrogens, corticosteroids, or bisphosphonates, or who had significant illness affecting bone metabolism were excluded

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polycan<br>Polycan 150mg for 12 weeks | Dietary Supplement: Polycan<br>* polycan 150 mg/d for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo 15mg for 12 weeks | Dietary Supplement: Placebo<br>* Placebo 150mg/d for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in DPD(Deoxypyridinoline) | DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in OSC(Osteocalcin) | OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) | CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in bALP(Bone-specific Alkaline Phosphatase) | bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 
| Changes in PTH(Parathyroid Hormone) | PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycan, Bone metabolism, Osteocalcin, Deoxypyridinoline