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

Primary Purpose

Osteopenia

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Oligopin
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia focused on measuring osteopenia, oligopin, postmenopause, antioxidant, bone

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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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Sites / Locations

  • Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

postmenopausal osteopenic women receiveing Oligopin

postmenopausal osteopenic women receiving placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plasma Osteocalcin Concentration
Osteocalcin levels in plasma
Plasma Carboxyl terminal collagen type I Concentration
Carboxyl terminal collagen type I in plasma
Osteocalcin/Carboxyl terminal collagen type I ratio
Osteocalcin/Carboxyl terminal collagen type I ratio

Secondary Outcome Measures

MnSOD activity in peripheral blood mononuclear cells
MnSOD activity in peripheral blood mononuclear cells
Catalase activity in peripheral blood mononuclear cells
Catalase activity in peripheral blood mono nuclear cells
MnSOD mRNA expression peripheral blood mononuclear cells
MnSOD mRNA expression peripheral blood mononuclear cells
Catalase mRNA expression peripheral blood mononuclear cells
Catalase mRNA expression peripheral blood mononuclear cells
NrF2 mRNA expression peripheral blood mononuclear cells
NrF2 mRNA expression peripheral blood mononuclear cells
Plasma Malondialdehide Concentration
Malondialdehide levels in plasma
total antioxidant capacity
total antioxidant capacity in plasma
protein carbonyl content
protein carbonyl content in plasma
Plasma Total thiol concentration
Total thiol level in plasma
Catalase activity in Plasma
Catalase activity in plasma
MnSOD activity in Plasma
MnSOD activity in plasma

Full Information

First Posted
August 22, 2017
Last Updated
May 18, 2020
Sponsor
Tehran University of Medical Sciences
Collaborators
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03260803
Brief Title
Oligopin Supplementation and Bone Turnover Markers and Antioxidant Changes in Postmenopausal Osteopenic Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
osteopenia, oligopin, postmenopause, antioxidant, bone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
postmenopausal osteopenic women receiveing Oligopin
Arm Type
Experimental
Arm Description
postmenopausal osteopenic women receiving Oligopin ,150 mg ,once daily, 12 week
Arm Title
postmenopausal osteopenic women receiving placebo
Arm Type
Placebo Comparator
Arm Description
postmenopausal osteopenic women receiving placebo, 150 mg,once daily,12 weeks
Intervention Type
Drug
Intervention Name(s)
Oligopin
Intervention Description
Oligopin ,150 mg ,once daily, 12 week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo,150 mg ,once daily, 12 week
Primary Outcome Measure Information:
Title
Plasma Osteocalcin Concentration
Description
Osteocalcin levels in plasma
Time Frame
up to third month after intervention
Title
Plasma Carboxyl terminal collagen type I Concentration
Description
Carboxyl terminal collagen type I in plasma
Time Frame
up to third month after intervention
Title
Osteocalcin/Carboxyl terminal collagen type I ratio
Description
Osteocalcin/Carboxyl terminal collagen type I ratio
Time Frame
up to third month after intervention
Secondary Outcome Measure Information:
Title
MnSOD activity in peripheral blood mononuclear cells
Description
MnSOD activity in peripheral blood mononuclear cells
Time Frame
Baseline and third month after intervention
Title
Catalase activity in peripheral blood mononuclear cells
Description
Catalase activity in peripheral blood mono nuclear cells
Time Frame
Baseline and third month after intervention
Title
MnSOD mRNA expression peripheral blood mononuclear cells
Description
MnSOD mRNA expression peripheral blood mononuclear cells
Time Frame
Baseline and third month after intervention
Title
Catalase mRNA expression peripheral blood mononuclear cells
Description
Catalase mRNA expression peripheral blood mononuclear cells
Time Frame
Baseline and third month after intervention
Title
NrF2 mRNA expression peripheral blood mononuclear cells
Description
NrF2 mRNA expression peripheral blood mononuclear cells
Time Frame
Baseline and third month after intervention
Title
Plasma Malondialdehide Concentration
Description
Malondialdehide levels in plasma
Time Frame
Baseline and third month after intervention
Title
total antioxidant capacity
Description
total antioxidant capacity in plasma
Time Frame
Baseline and third month after intervention
Title
protein carbonyl content
Description
protein carbonyl content in plasma
Time Frame
Baseline and third month after intervention
Title
Plasma Total thiol concentration
Description
Total thiol level in plasma
Time Frame
Baseline and third month after intervention
Title
Catalase activity in Plasma
Description
Catalase activity in plasma
Time Frame
Baseline and third month after intervention
Title
MnSOD activity in Plasma
Description
MnSOD activity in plasma
Time Frame
Baseline and third month after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
0098
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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