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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polycan | Experimental | Polycan 150mg for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo 15mg for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polycan | Dietary Supplement | polycan 150 mg/d for 12 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in DPD(Deoxypyridinoline) | DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Changes in OSC(Osteocalcin) | OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) | CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| Changes in bALP(Bone-specific Alkaline Phosphatase) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dal-Sik Kim, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare claims and management; Chonbuk National university | Jeonju | Jeollabuk-do | 560-822 | South Korea |
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 were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polycan | Polycan 150mg for 12 weeks |
| FG001 | Placebo | Placebo 15mg for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polycan | Polycan 150mg for 12 weeks |
| BG001 | Placebo | Placebo 15mg for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in DPD(Deoxypyridinoline) | DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | nanoMolar DPD per milliMolar creatine | 12weeks |
|
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polycan | Polycan 150mg for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dal-Sik Kim, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | dskim@chonbuk.ac.kr |
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| Dietary Supplement |
Placebo 150mg/d for 12 weeks |
|
bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).
| 12weeks |
| Changes in PTH(Parathyroid Hormone) | PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week). | 12weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Changes in OSC(Osteocalcin) | OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | ng/mL | 12weeks |
|
|
|
| Secondary | Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide) | CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | µg/L | 12weeks |
|
|
|
| Secondary | Changes in bALP(Bone-specific Alkaline Phosphatase) | bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | U/L | 12weeks |
|
|
|
| Secondary | Changes in PTH(Parathyroid Hormone) | PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | pg/mL | 12weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | Placebo 15mg for 12 weeks | 0 | 30 | 0 | 30 |
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