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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01402115
First received: July 21, 2011
Last updated: October 10, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety Study of Polycan on Bone Metabolism

Further study details as provided by Chonbuk National University Hospital:

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

  • Changes in OSC(Osteocalcin) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 21, 2011
Results First Received: July 26, 2012
Last Updated: October 10, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Polycan
Bone metabolism
Osteocalcin
Deoxypyridinoline

ClinicalTrials.gov processed this record on July 26, 2014