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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402115
First Posted: July 26, 2011
Last Update Posted: October 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
  Purpose

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.


Condition Intervention Phase
Bone Health in Perimenopausal Women Dietary Supplement: Polycan Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety Study of Polycan on Bone Metabolism

Further study details as provided by Soo-Wan Chae, Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in DPD(Deoxypyridinoline) [ Time Frame: 12weeks ]
    DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in OSC(Osteocalcin) [ Time Frame: 12weeks ]
    OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures:
  • Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) [ Time Frame: 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) [ Time Frame: 12weeks ]
    bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in PTH(Parathyroid Hormone) [ Time Frame: 12weeks ]
    PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).


Enrollment: 60
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polycan
Polycan 150mg for 12 weeks
Dietary Supplement: Polycan
polycan 150 mg/d for 12 weeks
Placebo Comparator: Placebo
Placebo 15mg for 12 weeks
Dietary Supplement: Placebo
Placebo 150mg/d for 12 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402115


Locations
Korea, Republic of
Healthcare claims and management; Chonbuk National university
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Dal-Sik Kim, MD Chonbuk National University Hospital
  More Information

Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01402115     History of Changes
Other Study ID Numbers: Glu-POLYCAN-001
First Submitted: July 21, 2011
First Posted: July 26, 2011
Results First Submitted: July 26, 2012
Results First Posted: October 5, 2012
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by Soo-Wan Chae, Chonbuk National University Hospital:
Polycan
Bone metabolism
Osteocalcin
Deoxypyridinoline