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

C

Chonbuk National University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Bone Health in Perimenopausal Women

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Polycan

Study type

Interventional

Funder types

Other

Identifiers

NCT01402115
Glu-POLYCAN-001

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Polycan
Experimental group
Description:
Polycan 150mg for 12 weeks
Treatment:
Dietary Supplement: Polycan
Placebo
Placebo Comparator group
Description:
Placebo 15mg for 12 weeks
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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