Evaluating the effects of pine bark extract supplementation on the bone turnover, as well as the possible mechanisms OPG/RANKL signaling in postmenopausal osteopenic women
Objectives: This study aims to determine the effects of Pine Bark Extract supplementation on bone turnover in postmenopausal osteopenic women
Design: The present study was designed as a randomized, double-blind, clinical trial
Setting and Conduct: 44 postmenopausal women with osteopenia referring to Shariati Hospital were invited based on inclusion criteria, after obtaining written consent and completing the general questionnaire, will be evaluated for the serum levels of their bone turnover markers. Then we randomly place them in two groups of supplement and placebo recipients and then we supplemented them for 12 weeks. At the end of 12 weeks, the tests will be performed again.
Participants including major eligibility: Participants in this study were selected from osteopenic postmenopausal women referring to Shariati Hospital in Tehran.
Intervention: will include pine bark extract supplementation (250 mg / day) or placebo for 12 weeks.
Main outcome measures: The main outcome measures will be included changes in bone turnover markers, and bone alkaline phosphatase and RANKL/OPG.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071123153N1
Registration date:2017-07-21, 1396/04/30
Registration timing:na
Last update:
Update count:0
Registration date
2017-07-21, 1396/04/30
Registrant information
Name
Seyed Bahman Panahande
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 3505
Email address
panahande-b@razi.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of pine bark extract supplementation on the bone turnover, as well as the possible mechanisms OPG/RANKL signaling in postmenopausal osteopenic women
Public title
Evaluating the effects of pine bark extract supplementation in postmenopausal osteopenic women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Postmenopausal women; Age: between 50-65 years; With a diagnosis of osteopenia. Osteopenia was defined as bone mineral density T-score at the spine and/or hip between 1 to 2.5 SD below the young normal ex-matched areal BMD of the reference database (According to the WHO); Normal function of thyroid, liver, and kidney.
Exclusion criteria: Report of fractures during the study; unwilling to continue participate in the project; Any visible side effects of supplements; The history of bone disease (Paget's disease, osteomalacia, etc.); History of chronic diseases, including cancer, diabetes, kidney failure, liver disease, systemic inflammatory disease, degenerative joint diseases and rheumatologic disorders;
Age
From 50 years old to 65 years old
Gender
Female
Phase
2
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
The ethics committee of Tehran University of Medical Sciences
Street address
4th Floor, No. 23, before Pour Sina St. - 16th Azad St. - Keshavarz Blvd
City
Tehran
Postal code
Approval date
2017-01-07, 1395/10/18
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1408
Health conditions studied
1
Description of health condition studied
Osteopenia
ICD-10 code
M81.0
ICD-10 code description
Postmenopausal osteoporosis
Primary outcomes
1
Description
Procollagen type I N-terminal propeptide (PINP)
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
ELISA
2
Description
Cross-Linked Carboxy-Terminal Telopeptide of Type I Collagen
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
ELISA
3
Description
Bone alkaline phosphatase (BAP)
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
ELISA
4
Description
Receptor activator of nuclear factor kappa-B ligand (RANKL)
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
ELISA
5
Description
Osteoprotegerin (OPG)
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Weight
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
digital scale
Intervention groups
1
Description
Intervention group: Daily intake of 5 Oligopin capsules for 12 weeks (2 with breakfast, 2 with lunch, 1 with dinner) (Each capsule contains 50 mg of French pine bark extract)
Category
Treatment - Drugs
2
Description
Control group: Daily intake of 5 capsules containing water for 12 weeks (2 with breakfast, 2 with lunch, 1 with dinner) (quite similar to pine bark extract capsule)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Osteoporosis Research Center of Shariati Hospital of Tehran University of Medical Sciences
Full name of responsible person
Seyed Bahman Panahande
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice Chancellor of Research, International Campus
Full name of responsible person
Dr Mohammad Reza Hadiyan, Deputy Unit
Street address
Tehran University of Medical Sciences Office of Vice-President for Research Affairs, Number 124 , Baradaran-e-Mozaffar St.,Dameshgh St., Vali-e Asr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Vice Chancellor of Research, International Campus
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
Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of
Full name of responsible person
Seyed Bahman Panahande
Position
PhD Candidate in Nutritional Sciences
Other areas of specialty/work
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.,Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8895 5975
Fax
Email
panahande.b@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Nutrition, School of Nutritional Sciences, Tehran University of Medical Scien
Full name of responsible person
Dr Saeed Hosseini
Position
Associate Professor of Nutritional Sciences
Other areas of specialty/work
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.,Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8899 3037
Fax
Email
saeedhmdphd@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Bahman Panahande
Position
PhD Candidate in Nutritional Sciences
Other areas of specialty/work
Street address
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.,Keshavarz Blvd, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8899 3073
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)