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

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ClinicalTrials.gov Identifier: NCT01402115
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : October 5, 2012
Last Update Posted : October 12, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, 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.


Condition or disease Intervention/treatment Phase
Bone Health in Perimenopausal Women Dietary Supplement: Polycan Dietary Supplement: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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



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

  2. 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 :
  1. 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).

  2. 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).

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



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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

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

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 Posted: July 26, 2011    Key Record Dates
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