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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260803
• Other study ID #: 34606
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2020
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria: Postmenopausal women; Aged between 50-65; Diagnosis of osteopenia based on Tscore ( -2.5 SD = Tscore = -1 SD); To have equal physical, pediatric and complementary therapies for at least three months before entrance to study ;Absence of history of Bone Diseases; Absence of the history of chronic diseases including cancer, diabetes, kidney failure, liver disease, systemic inflammatory diseases, degenerative joint diseases and rheumatologic disorders, primary thalassemia, hyperparathyroidism, hyperthyroidism-Cushing's, Hypercalcaemia syndrome, Hyperglycemia ;Absence of gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, and chronic diarrhea and gastric or duodenal ulcers treated or with a history of gastrointestinal bleeding (according to the patient's history); Absence of history of the use of drugs that affect bone metabolism and have been regularly used for at least 6 months in the past two years: such as osteoporosis drugs (bisphosphonates, estrogen receptor selective agonists / selective antagonists, alternative HRTs, PTH), diuretics, thiazides, anticonvulsants (phenytoin, phenobarbital, sodium valproate), glucocorticoids, nonsteroidal anti-inflammatory drugs such as analgesics (nonsteroidal anti-inflammatory drugs such as naproxen, aspirin and ibuprofen), cigarettes; Absence of motor disabilities, skeletal disorders, untreated psychiatric illnesses such as psychosis, Alzheimer's disease, Parkinson's disease; To accept randomization; Absence of morbid Obesity: BMI is above 40

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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Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Drug:
• Oligopin
Oligopin ,150 mg ,once daily, 12 week
• Placebo
Placebo,150 mg ,once daily, 12 week

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Osteocalcin Concentration	Osteocalcin levels in plasma	up to third month after intervention
Primary	Plasma Carboxyl terminal collagen type I Concentration	Carboxyl terminal collagen type I in plasma	up to third month after intervention
Primary	Osteocalcin/Carboxyl terminal collagen type I ratio	Osteocalcin/Carboxyl terminal collagen type I ratio	up to third month after intervention
Secondary	MnSOD activity in peripheral blood mononuclear cells	MnSOD activity in peripheral blood mononuclear cells	Baseline and third month after intervention
Secondary	Catalase activity in peripheral blood mononuclear cells	Catalase activity in peripheral blood mono nuclear cells	Baseline and third month after intervention
Secondary	MnSOD mRNA expression peripheral blood mononuclear cells	MnSOD mRNA expression peripheral blood mononuclear cells	Baseline and third month after intervention
Secondary	Catalase mRNA expression peripheral blood mononuclear cells	Catalase mRNA expression peripheral blood mononuclear cells	Baseline and third month after intervention
Secondary	NrF2 mRNA expression peripheral blood mononuclear cells	NrF2 mRNA expression peripheral blood mononuclear cells	Baseline and third month after intervention
Secondary	Plasma Malondialdehide Concentration	Malondialdehide levels in plasma	Baseline and third month after intervention
Secondary	total antioxidant capacity	total antioxidant capacity in plasma	Baseline and third month after intervention
Secondary	protein carbonyl content	protein carbonyl content in plasma	Baseline and third month after intervention
Secondary	Plasma Total thiol concentration	Total thiol level in plasma	Baseline and third month after intervention
Secondary	Catalase activity in Plasma	Catalase activity in plasma	Baseline and third month after intervention
Secondary	MnSOD activity in Plasma	MnSOD activity in plasma	Baseline and third month after intervention