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Completed

NCT Number: NCT01402115

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

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.

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Key information

Conditions

Bone Health in Perimenopausal Women

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Healthcare claims and management; Chonbuk National university

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polycan

Dietary Supplement

polycan 150 mg/d for 12 weeks

Placebo

Dietary Supplement

Placebo 150mg/d for 12 weeks

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

Efficacy and Safety Study of Polycan on Bone Metabolism

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 26, 2011
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.