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

Efficacy and Safety Study of Polycan on Bone Metabolism

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01402115

Enrollment

Registered

2011-07-26

Start date

2008-11-30

Completion date

2009-05-31

Last updated

2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Health in Perimenopausal Women

Keywords

Polycan, Bone metabolism, Osteocalcin, Deoxypyridinoline

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.

Interventions

DIETARY_SUPPLEMENTPolycan

polycan 150 mg/d for 12 weeks

DIETARY_SUPPLEMENTPlacebo

Placebo 150mg/d for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in DPD(Deoxypyridinoline)	12weeks	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in OSC(Osteocalcin)	12weeks	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary

Measure	Time frame	Description
Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)	12weeks	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)	12weeks	bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in PTH(Parathyroid Hormone)	12weeks	PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).

Countries

South Korea

Participant flow

Recruitment details

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-assignment details

The criteria were an age from 40 to 70 years, 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).

Participants by arm

Arm	Count
Polycan Polycan 150mg for 12 weeks	30
Placebo Placebo 15mg for 12 weeks	30
Total	60

Baseline characteristics

Characteristic	Placebo	Polycan	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	30 Participants	30 Participants	60 Participants
Age Continuous	52.9 years STANDARD_DEVIATION 5.8	52.8 years STANDARD_DEVIATION 6.3	52.8 years STANDARD_DEVIATION 5.8
Region of Enrollment Korea, Republic of	30 participants	30 participants	60 participants
Sex: Female, Male Female	30 Participants	30 Participants	60 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

Primary