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

NCT03260803 | Completed Phase 3 DMC

• 1 other identifier: 34606
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

osteopenia; oligopin; postmenopause; antioxidant; bone

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• MnSOD activity in peripheral blood mononuclear cells

  Baseline and third month after intervention

• Catalase activity in peripheral blood mononuclear cells

  Baseline and third month after intervention

• MnSOD mRNA expression peripheral blood mononuclear cells

  Baseline and third month after intervention

• Catalase mRNA expression peripheral blood mononuclear cells

  Baseline and third month after intervention

• NrF2 mRNA expression peripheral blood mononuclear cells

  Baseline and third month after intervention

Study Arms (2)

postmenopausal osteopenic women receiveing Oligopin

EXPERIMENTAL

postmenopausal osteopenic women receiving Oligopin ,150 mg ,once daily, 12 week

Drug: Oligopin

postmenopausal osteopenic women receiving placebo

PLACEBO COMPARATOR

postmenopausal osteopenic women receiving placebo, 150 mg,once daily,12 weeks

Drug: Placebo

Interventions

Oligopin DRUG

Oligopin ,150 mg ,once daily, 12 week

postmenopausal osteopenic women receiveing Oligopin

Placebo DRUG

Placebo,150 mg ,once daily, 12 week

postmenopausal osteopenic women receiving placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Fracture report during the study period; Unwillingness of participants to continue the project; The occurrence of any visible side effects of supplemental effects

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Iran University of Medical Sciences: collaborator

Study Sites (1)

Tehran University of Medical Sciences

Tehran, 0098, Iran

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Oligopin

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

IR (1)