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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Soo-Wan Chae, Chonbuk National University Hospital

ClinicalTrials.gov Identifier:

NCT01402115

First received: July 21, 2011

Last updated: October 10, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2011

Last Updated Date

October 10, 2012

Start Date ^ICMJE

November 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in DPD(Deoxypyridinoline) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in OSC(Osteocalcin) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

Original Primary Outcome Measures ^ICMJE

Deoxypyridinoline [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01402115 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in PTH(Parathyroid Hormone) [ Time Frame: 12weeks ] [ Designated as safety issue: Yes ]
PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).

Original Secondary Outcome Measures ^ICMJE

collagen type 1 cross-linked C-telopeptide [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
bone-specific alkaline phosphatase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
parathyroid hormone [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
osteocalcin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy and Safety Study of Polycan on Bone Metabolism

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Bone Health in Perimenopausal Women

Intervention ^ICMJE

Dietary Supplement: Polycan
polycan 150 mg/d for 12 weeks
Dietary Supplement: Placebo
Placebo 150mg/d for 12 weeks

Study Arm (s)

Experimental: Polycan
Polycan 150mg for 12 weeks

Intervention: Dietary Supplement: Polycan
Placebo Comparator: Placebo
Placebo 15mg for 12 weeks

Intervention: Dietary Supplement: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01402115

Other Study ID Numbers ^ICMJE

Glu-POLYCAN-001

Has Data Monitoring Committee

Yes

Responsible Party

Soo-Wan Chae, Chonbuk National University Hospital

Study Sponsor ^ICMJE

Chonbuk National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dal-Sik Kim, MD

Chonbuk National University Hospital

Information Provided By

Chonbuk National University Hospital

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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