Phase 3
Completed N=60
A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
Bone Health in Perimenopausal Women
Source: ClinicalTrials.gov NCT01402115 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Changes in DPD(Deoxypyridinoline) — 7.1; 6.4; 6.2; 5.6 nanoMolar DPD per milliMolar creatine
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in DPD(Deoxypyridinoline) |
7.1; 6.4; 6.2; 5.6 | — |
| PRIMARY Changes in OSC(Osteocalcin) |
16.1; 14.2; 19.8; 17.0 | — |
| SECONDARY Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) |
344; 314; 341; 301 | — |
| SECONDARY Changes in bALP(Bone-specific Alkaline Phosphatase) |
31.8; 28.6; 31.8; 29.8 | — |
| SECONDARY Changes in PTH(Parathyroid Hormone) |
32.8; 31.1; 35.0; 33.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01402115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.