The effect of pine bark extract supplementation on metabolic status , serum levels of ICAM-1 and VCAM-1 and anthropometric indeces in type 2 diabetic patients with microalbuminuria
The effects of pine bark extract supplementation on metabolic status and serum levels of ICAM1, VCAM1 and anthropometric indices in type 2 diabetes mellitus patients with microalbuminuria
Design
Randomized, double-blind, placebo-controlled study population: Individuals with type 2 diabetes with microalbuminuria were randomly divided into 2 groups, including pine bark extract recipients and placebo recipients,
for 8 weeks.
Sample size: 46 people (2 groups of 23 persons).
Study Intervention: pine bark extract supplement
Settings and conduct
For each person, the general characteristics questionnaire, anthropometric evaluations, nutrition inventory and the International Assessment of Physical Activity IPAQ will be completed. To measure all biochemical parameters, 10cc of venous blood is collected fasting (at the beginning and end of the study) and their serum will be separated and kept at -70° until testing. To obtain the ratio of albumin to creatinine, a randomized urine sample will be taken and kept at -20°.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women 30-50, and men 30-65 years old,
Microalbuminuria diagnosis based on ACR criteria in randomized urine specimen;
Exclusion criteria:
history of heart failure; Infectious diseases of the urine and prostate; Acute febrile illness; uncontrolled blood pressure and blood glucose; Glomerulonephritis; Polycystic kidney disease; nephropathy; Insulin therapy; smoking; Pregnancy-lactation
Intervention groups
Group 1 receiving pine bark extract (2 capsules of 50 mg)
Group 2 receiving placebo (2 capsules of 50 mg containing starch)
Main outcome variables
Effect of pine bark extract supplementation on metabolic status, serum level of ICAM1, VCAM1 and anthropometric indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100408003664N21
Registration date:2018-04-26, 1397/02/06
Registration timing:registered_while_recruiting
Last update:2018-04-26, 1397/02/06
Update count:0
Registration date
2018-04-26, 1397/02/06
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
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 pine bark extract supplementation on metabolic status , serum levels of ICAM-1 and VCAM-1 and anthropometric indeces in type 2 diabetic patients with microalbuminuria
Public title
Effect of pine bark extract on the treatment of patients with type 2 diabetes with microalbuminuria
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteered to participate in the study with type 2 diabetes
People (men and women) who have been diagnosed with diabetes for at least one year.
Age:Women 30-50 years old Men: 30-65 years old
Microalbuminuria diagnosis based on ACR criteria in randomized urine specimen
Exclusion criteria:
history of congestive heart failure,Infectious diseases of the urine, prostate,Acute febrile illnessUncontrolled blood pressureGlomerulonephritisPolycystic kidney disease,Acute hyperglycemia,The field of hereditary nephropathy
Insulin therapy
smoking
Extreme sports activity (24 hours before sample collection)
Pregnancy-lactation
Use of any type of multi-vitamin supplement and so on during the study
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age, sex and BMI variables
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo and supplement will be packed in the same number in similar envelopes. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz - GolgaSht - Attar Neyshabour Ave - Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.TBZMED.REC.1396.1079
Health conditions studied
1
Description of health condition studied
Type 2 diabetes with microalbuminuria
ICD-10 code
E11.2
ICD-10 code description
Type 2 diabetes mellitus with renal complications
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotometer
2
Description
Level of Serum Insulin
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With ELISA
3
Description
Homeostatic Model Assessment of Insulin Resistance(HOMA-IR)
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Calculated According to The Formula
4
Description
HbA1C
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With HPLC
5
Description
Total Cholestrol
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotometer
6
Description
HDL-C
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotometer
7
Description
LDL-C
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Calculated According to The Friedwald Formula
8
Description
TG
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With Spectrophotomete
9
Description
ICAM-1(Intra cellular adhesion molecule1)
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With ELISA
10
Description
VCAM-1( vascular cell adhesion molecule 1 )
Timepoint
Before of Intervention and 8 Weeks After Intervention
Method of measurement
Blood Sampling and Analysing With ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pine bark extract (Oligopin) will be taken as two capsules of 50 mg with a meal (breakfast and lunch) for 8 weeks, the product of Aramis Faramad Company
Category
Treatment - Drugs
2
Description
Control group: 50 mg capsule containing starch 2 pcs. Per day with meals (breakfast and lunch) for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Elham Navval Esfahlan
Street address
East Azarbaijan - Tabriz - Golghaste St, next to Tabriz University - Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
9137913316
Phone
+98 41 3334 7056
Email
elham.naval@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
alireza ostad rahimi
Street address
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
elham.naval@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham navval esfahlan
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sience,Nutrition Faculty, Attar Neyshabori,Golgasht street,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413335758082
Email
elham.naval@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Navval Esfahlan
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sience,Nutrition Faculty, Attar Neyshabori,Golgasht street,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 413335758082
Email
elham.naval@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Navval Esfahlan
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41333578082
Fax
+98 41 3334 0634
Email
elham.naval@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available