Evaluating 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
We 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. Forty four women with osteopenia were 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060334308N1
Registration date:2017-08-20, 1396/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Solaleh Emamgholipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6443 2623
Email address
semamgholipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-08-15, 1396/05/24
Expected recruitment end date
2018-08-15, 1397/05/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating 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
Public title
Evaluating the effects of oligopin supplementation on the turnover of bone formation and antioxidant changes in postmenopausal osteopenic women
Purpose
Prevention
Inclusion/Exclusion 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
Age
From 50 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences (TUMS)
Street address
Tehran University of Medical Sciences (TUMS)
City
Tehran
Postal code
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2372
Health conditions studied
1
Description of health condition studied
Osteopenia
ICD-10 code
M 81.0
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
Bone alkaline phospatase
Timepoint
Before and third month after intervention
Method of measurement
ELISA
2
Description
Carboxy terminal collagen type I
Timepoint
Before and third month after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
MnSOD activity in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
At first of study,third month
Method of measurement
spectrophotometer
2
Description
Catalse activity in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
3
Description
NrF2 protein levels in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
ELISA
4
Description
MnSOD expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
real-time PCR
5
Description
Catalase expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
real-time PCR
6
Description
NrF2 expression in peripheral blood mononuclear cells (PBMCs) in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
real-time PCR
7
Description
MDA plasma levels in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
8
Description
Plasma levels of total antioxidant capacity in postmenopausal osteopenic women and placebo-concurrent controls
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
9
Description
Evaluating plasma levels of protein carbonylation in postmenopausal osteopenic women and placebo-concurrent controlsP
Timepoint
Before intervention,third month after intervention
Method of measurement
spectrophotometer
Intervention groups
1
Description
placebo, 150 mg,once daily,12 weeks
Category
Treatment - Drugs
2
Description
Oligopin ,150 mg ,once daily, 12 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research,Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Faculty of Medicine, Tehran University of Medical Sciences, Poursina avenue Tehran Tehran Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research,Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Majidi
Position
PhD student
Other areas of specialty/work
Street address
Department of Biochemistry, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran