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

Phase 2

Completed

• Conditions: Bone Health in Perimenopausal Women
• Interventions: Dietary Supplement: Polycan; Dietary Supplement: Placebo

• Registration Number: NCT01402115
• Lead Sponsor: Chonbuk National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-02
• Study Completion: 2009-05
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Results First Submitted: 2012-07-26
• Results First Submitted QC: 2012-09-05
• Status Verified: 2012-10
• Results First Posted: 2012-10-05
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polycan	Polycan	Polycan 150mg for 12 weeks
Placebo	Placebo	Placebo 15mg for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in DPD(Deoxypyridinoline)	12weeks	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in OSC(Osteocalcin)	12weeks	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Healthcare claims and management; Chonbuk National university; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of