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| Name | Class |
|---|---|
| Iran University of Medical Sciences | OTHER |
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Osteoporosis fractures impose a significant economic burden on the health system. There is evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women), and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the prevention of osteopenia progression towards osteoporosis has been considered as an important issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the equilibrium between bone formation and resorption done by simultaneously regulating osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption contributes to reducing bone mineral density and hence increasing the risk of osteoporosis
Recently, new therapies have been focused on use of medicinal herbs, especially phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act both on osteoblast and on osteoclast.
Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in vitro studies and animal models. Investigators aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Participants are forty four women with osteopenia divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postmenopausal osteopenic women receiveing Oligopin | Experimental | postmenopausal osteopenic women receiving Oligopin ,150 mg ,once daily, 12 week |
|
| postmenopausal osteopenic women receiving placebo | Placebo Comparator | postmenopausal osteopenic women receiving placebo, 150 mg,once daily,12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oligopin | Drug | Oligopin ,150 mg ,once daily, 12 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Osteocalcin Concentration | Osteocalcin levels in plasma | up to third month after intervention |
| Plasma Carboxyl terminal collagen type I Concentration | Carboxyl terminal collagen type I in plasma | up to third month after intervention |
| Osteocalcin/Carboxyl terminal collagen type I ratio | Osteocalcin/Carboxyl terminal collagen type I ratio | up to third month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| MnSOD activity in peripheral blood mononuclear cells | MnSOD activity in peripheral blood mononuclear cells | Baseline and third month after intervention |
| Catalase activity in peripheral blood mononuclear cells |
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Inclusion Criteria:
Exclusion Criteria:
Fracture report during the study period; Unwillingness of participants to continue the project; The occurrence of any visible side effects of supplemental effects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran University of Medical Sciences | Tehran | 0098 | Iran |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C587735 | Oligopin |
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| Placebo | Drug | Placebo,150 mg ,once daily, 12 week |
|
Catalase activity in peripheral blood mono nuclear cells
| Baseline and third month after intervention |
| MnSOD mRNA expression peripheral blood mononuclear cells | MnSOD mRNA expression peripheral blood mononuclear cells | Baseline and third month after intervention |
| Catalase mRNA expression peripheral blood mononuclear cells | Catalase mRNA expression peripheral blood mononuclear cells | Baseline and third month after intervention |
| NrF2 mRNA expression peripheral blood mononuclear cells | NrF2 mRNA expression peripheral blood mononuclear cells | Baseline and third month after intervention |
| Plasma Malondialdehide Concentration | Malondialdehide levels in plasma | Baseline and third month after intervention |
| total antioxidant capacity | total antioxidant capacity in plasma | Baseline and third month after intervention |
| protein carbonyl content | protein carbonyl content in plasma | Baseline and third month after intervention |
| Plasma Total thiol concentration | Total thiol level in plasma | Baseline and third month after intervention |
| Catalase activity in Plasma | Catalase activity in plasma | Baseline and third month after intervention |
| MnSOD activity in Plasma | MnSOD activity in plasma | Baseline and third month after intervention |