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Completed

NCT Number: NCT03260803

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

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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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tehran University of Medical Sciences

Tehran, 0098, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Oligopin

Drug

Oligopin ,150 mg ,once daily, 12 week

Placebo

Drug

Placebo,150 mg ,once daily, 12 week

Primary outcomes

  1. Plasma Osteocalcin Concentration

    Time frame: up to third month after intervention

    Osteocalcin levels in plasma

  2. Plasma Carboxyl terminal collagen type I Concentration

    Time frame: up to third month after intervention

    Carboxyl terminal collagen type I in plasma

  3. Osteocalcin/Carboxyl terminal collagen type I ratio

    Time frame: up to third month after intervention

    Osteocalcin/Carboxyl terminal collagen type I ratio

Secondary outcomes

  1. MnSOD activity in peripheral blood mononuclear cells

    Time frame: Baseline and third month after intervention

    MnSOD activity in peripheral blood mononuclear cells

  2. Catalase activity in peripheral blood mononuclear cells

    Time frame: Baseline and third month after intervention

    Catalase activity in peripheral blood mono nuclear cells

  3. MnSOD mRNA expression peripheral blood mononuclear cells

    Time frame: Baseline and third month after intervention

    MnSOD mRNA expression peripheral blood mononuclear cells

  4. Catalase mRNA expression peripheral blood mononuclear cells

    Time frame: Baseline and third month after intervention

    Catalase mRNA expression peripheral blood mononuclear cells

  5. NrF2 mRNA expression peripheral blood mononuclear cells

    Time frame: Baseline and third month after intervention

    NrF2 mRNA expression peripheral blood mononuclear cells

  6. Plasma Malondialdehide Concentration

    Time frame: Baseline and third month after intervention

    Malondialdehide levels in plasma

  7. total antioxidant capacity

    Time frame: Baseline and third month after intervention

    total antioxidant capacity in plasma

  8. protein carbonyl content

    Time frame: Baseline and third month after intervention

    protein carbonyl content in plasma

  9. Plasma Total thiol concentration

    Time frame: Baseline and third month after intervention

    Total thiol level in plasma

  10. Catalase activity in Plasma

    Time frame: Baseline and third month after intervention

    Catalase activity in plasma

  11. MnSOD activity in Plasma

    Time frame: Baseline and third month after intervention

    MnSOD activity in plasma

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Iran University of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 24, 2017
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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