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

NCT01402115 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-10-12

Study results available
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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.

Conditions

  • Bone Health in Perimenopausal Women

Interventions

DIETARY_SUPPLEMENT

Polycan

polycan 150 mg/d for 12 weeks

DIETARY_SUPPLEMENT

Placebo

Placebo 150mg/d for 12 weeks

Sponsors & Collaborators

  • Chonbuk National University Hospital

    lead OTHER

Principal Investigators

  • Dal-Sik Kim, MD · Chonbuk National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-02-28
Completion
2009-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01402115 on ClinicalTrials.gov