NCT03260803

Oligopin Supplementation and Bone Turnover Markers and Antioxidant Changes in Postmenopausal Osteopenic Women

Valuating the Effects of Oligopin Supplementation on the Turnover of Bone Formation and Antioxidant Changes in Postmenopausal Osteopenic Women: A Randomized Double-blind Clinical Trial With Placebo-concurrent Controls

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteopenia

Interventions

Type	Name	Description
DRUG	Oligopin	Oligopin ,150 mg ,once daily, 12 week
DRUG	Placebo	Placebo,150 mg ,once daily, 12 week

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2017-08-24
• Last updated: 2020-05-20

Locations

1 site across 1 country: Iran