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

NCT01402115 | Completed Phase 2 Results DMC

• 1 other identifier: Glu-POLYCAN-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Health in Perimenopausal Women

Keywords

Polycan; Bone metabolism; Osteocalcin; Deoxypyridinoline

Outcome Measures

Primary Outcomes (2)

• Changes in DPD(Deoxypyridinoline)

  DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

  12weeks

• Changes in OSC(Osteocalcin)

  OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

  12weeks

Secondary Outcomes (3)

• Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)

  12weeks

• Changes in bALP(Bone-specific Alkaline Phosphatase)

  12weeks

• Changes in PTH(Parathyroid Hormone)

  12weeks

Study Arms (2)

Polycan

EXPERIMENTAL

Polycan 150mg for 12 weeks

Dietary Supplement: Polycan

Placebo

PLACEBO COMPARATOR

Placebo 15mg for 12 weeks

Dietary Supplement: Placebo

Interventions

Polycan DIETARY_SUPPLEMENT

polycan 150 mg/d for 12 weeks

Polycan

Placebo DIETARY_SUPPLEMENT

Placebo 150mg/d for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Healthcare claims and management; Chonbuk National university

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Results Point of Contact

• Title: Dr. Dal-Sik Kim, MD
• Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

dskim@chonbuk.ac.kr

82-63-276-8284

Study Officials

• Dal-Sik Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 26, 2011
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 12, 2012
• Results First Posted: October 5, 2012

Record last verified: 2012-10

Locations

KR (1)