French Maritime Pine Bark Extract antidiabetic effects and cardiovascular risk factors improvement review.
Encouraging diabetic patients to use French Maritime Pine Bark Extract as alternative for chemically decreasing glucose agents, and metabolic syndrome risk factors improvement after supplement using
Design
The present study was designed in a double blinded randomized clinical trial in two groups of placebo and placebo with blood sampling in two rounds (before and after supplement take).
Settings and conduct
This research will be conducted in the clinic of diabetes of Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with type 2 diabetes from at least 3 years ago till now and mild to moderate systolic blood pressure (13-15 mm Hg)
Exclusion criteria: Insulin usage, pregnancy and lactation, daily use of any supplement except multivitamin, major diseases such as cancer, asthma , heart failure and other cardiovascular problems.
Intervention groups
The only intervention in this project is French Maritime Pine Bark Extract (Oligopin) use and the complementary placebo in two randomized groups of 15 people each.
Main outcome variables
Fasting blood glucose, Low density lipoprotein, High density lipoprotein &Systolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180718040512N1
Registration date:2018-08-04, 1397/05/13
Registration timing:prospective
Last update:2018-08-04, 1397/05/13
Update count:1
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Rasool Orouji
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 21 4410 3316
Email address
orouji@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-12, 1397/05/21
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of French Maritime Pine Bark Extract ( Oligopin® ) on FBS, LDL ,HDL and systolic blood pressure in women with type II diabetic
Public title
Evaluation of the effect of French Maritime Pine Bark Extract on selected blood type indices in type 2 diabetic women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female
At least three years of type 2 diabetes history
Having mild to moderate systolic blood pressure (15-13 mm Hg)
Exclusion criteria:
Male
Having type 1 diabetes
Insulin usage
Daily usage of any supplement except multivitamin
Suffering from any major diseases such as cancer, asthma , heart failure and other cardiovascular Disorders
Pregnancy and lactation
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Following notification and inviting the patients for further cooperation in the research project, the goals and research methodology were provided to the them and filled the informed consent& questionnaires.A sample of 30 people divided randomly into two homogenous groups of 15 people each. One group uses two 50 mg capsules of oligopin supplement per day for 6 weeks and in the same time the other group will use proprietary placebo
Blinding (investigator's opinion)
Double blinded
Blinding description
Thirty people are randomly will be assign to one of two homogeneous supplement and placebo groups of 15 people each.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Payame Noor University
Street address
Mini City, Army Blvd, First Oil Town, Palm Alley, Central Organization of Payame Noor University
City
Tehran
Province
Tehran
Postal code
193954697
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.PNU.REC.1397.009
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood glucose, Low density lipoprotein, High density lipoprotein &Systolic blood pressure
Timepoint
Blood sampling is two times before and after supplement take (beginning of the study and six weeks after supplement take)
Method of measurement
The variable of blood pressure is taken by a digital barometric device in the clinic, and other blood biochemical variables will be performed by the relevant specialist in the clinic laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: French Marine Pine Extract (Oligopin) users
Category
Prevention
2
Description
Control group: Placebo users
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک دیابت بیمارستان امام خمینی
Full name of responsible person
Dr Manoochehr khan nakhjavani
Street address
Keshavarz Blvd., Dr. Gharib Ave., Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2281
Fax
Email
Orouji@health.gov.ir
Web page address
http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
Dr Reza hajihosseini
Street address
Tehran, Hakimiyeh, Water Organization Street, 15th Street, Shirazi, No. 3
City
Tehran
Province
Tehran
Postal code
1659639884
Phone
+98 21 7731 1286
Fax
+98 21 7731 8537
Email
hosseini@pnu.ac.ir
Web page address
http://teh-shargh.pnu.ac.ir/Portal/Home/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payam Noor University
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Payam Noor University
Full name of responsible person
Rasool Orouji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
No. 8, Bahar Alley, Tavan Boulevard ,Ayatollah Kashani St.
City
Tehran
Province
Tehran
Postal code
1484774463
Phone
+98 21 4410 3316
Fax
+98 21 8145 4615
Email
orouji@health.gov.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Payam Noor University
Full name of responsible person
Rasool Orouji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
No. 8, Bahar Alley, Tavan Boulevard ,Ayatollah Kashani St.
City
Tehran
Province
Tehran
Postal code
1484774463
Phone
+98 21 4410 3316
Fax
+98 21 8145 4615
Email
orouji@health.gov.ir
Person responsible for updating data
Contact
Name of organization / entity
Payam Noor University
Full name of responsible person
Rasool Orouji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
No. 8, Bahar Alley, Tavan Boulevard ,Ayatollah Kashani St.
City
Tehran
Province
Tehran
Postal code
1484774463
Phone
+98 21 4410 3316
Fax
+98 21 8145 4615
Email
orouji@health.gov.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the research participants, information, I do not intend to publish the research participants, data.