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

• Sponsor: Chonbuk National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01402115
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Health in Perimenopausal Women	Dietary Supplement: Polycan; Dietary Supplement: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Safety Study of Polycan on Bone Metabolism
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polycan Polycan 150mg for 12 weeks	Dietary Supplement: Polycan; polycan 150 mg/d for 12 weeks
Placebo Comparator: Placebo Placebo 15mg for 12 weeks	Dietary Supplement: Placebo; Placebo 150mg/d for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Changes in DPD(Deoxypyridinoline) [12weeks]

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

2. Changes in OSC(Osteocalcin) [12weeks]

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

Secondary Outcome Measures

1. 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).

2. 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).

3. Changes in PTH(Parathyroid Hormone) [12weeks]

   PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Healthcare claims and management; Chonbuk National university	Jeonju	Jeollabuk-do	Korea, Republic of	560-822

Sponsors and Collaborators

• Chonbuk National University Hospital

Investigators

• Principal Investigator: Dal-Sik Kim, MD, Chonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT01402115
• Other Study ID Numbers: Glu-POLYCAN-001
• First Posted: Jul 26, 2011
• Last Update Posted: Oct 12, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital: Polycan; Bone metabolism; Osteocalcin; Deoxypyridinoline

Study Results

Participant Flow

Recruitment Details	Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment Detail	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).

Arm/Group Title	Polycan	Placebo
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks
Period Title: Overall Study
STARTED	30	30
COMPLETED	29	29
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Polycan	Placebo	Total
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.8 (6.3)	52.9 (5.8)	52.8 (5.8)
Sex: Female, Male (Count of Participants)
Female	30 100%	30 100%	60 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Korea, Republic of	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Changes in DPD(Deoxypyridinoline)
Description	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Polycan	Placebo
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks
Measure Participants	29	29
Pre	7.1 (2.2)	6.4 (1.7)
Post	6.2 (2.1)	5.6 (1.5)

2. Primary Outcome

Title	Changes in OSC(Osteocalcin)
Description	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Polycan	Placebo
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks
Measure Participants	29	29
Pre	16.1 (6.8)	14.2 (5.2)
Post	19.8 (7.7)	17.0 (6.8)

3. Secondary Outcome

Title	Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
Description	CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Polycan	Placebo
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks
Measure Participants	29	29
Pre	344 (183)	314 (217)
Post	341 (171)	301 (157)

4. Secondary Outcome

Title	Changes in bALP(Bone-specific Alkaline Phosphatase)
Description	bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Polycan	Placebo
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks
Measure Participants	29	29
Pre	31.8 (11.3)	28.6 (9.7)
Post	31.8 (11.7)	29.8 (9.5)

5. Secondary Outcome

Title	Changes in PTH(Parathyroid Hormone)
Description	PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame	12weeks

Outcome Measure Data

Analysis Population Description

per protocol analysis

Arm/Group Title	Polycan	Placebo
Arm/Group Description	Polycan 150mg for 12 weeks	Placebo 15mg for 12 weeks
Measure Participants	29	29
Pre	32.8 (10.4)	31.1 (8.7)
Post	35.0 (9.3)	33.6 (7.5)

Adverse Events

Adverse Event Reporting Description	Serious and/or other [non-serious] adverse events were not collected/assessed
Arm/Group Title	Polycan		Placebo
Arm/Group Description	Polycan 150mg for 12 weeks		Placebo 15mg for 12 weeks
All Cause Mortality
	Polycan		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Polycan		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Polycan		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.