The aim of the present study was to determine the effects of thirty days of pomegranate extract oral supplementation on plasma inflammatory and oxidative stress bio-markers of the overweight and obese individuals. In this randomized, double-blind, placebo-controlled study forty-eight healthy obese and overweight participants who went to the Shariati hospital for a regular check up and did not have any diseases and also did not use any pharmaceutical drugs as well as dietary supplements within the 3 months prior to the study; were randomly assigned to receive either 1000 mg of pomegranate extract (PE), or a placebo (PL), daily for 30 days. At baseline, and after 30 days of treatment 10 ml blood was collected after a 12hr fasting state. In this study, plasma concentrations of MDA, IL-6, hs-CRP were assessed, as were the levels of serum lipids, glucose and insulin. The study was blind for both the participants and the researchers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062722934N1
Registration date:2015-07-24, 1394/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Banafshe Hosseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5805
Email address
b-hosseini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effects of Pomegranate Extract Supplementation on Inflammation in Overweight and Obese Individuals
Public title
Investigate the effects of Pomegranate Extract Supplementation on Inflammation in Overweight and Obese Individuals
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Willingness to participation; Between the age 30-60 years old and Having a BMI within the range 25-40 kgm2; does not have a history of use of any dietary supplements within 3 months prior to the study; does not smoking or alcohol consumption; does not take any cholesterol; triglyceride as well as blood lowering medicine; does not suffer from any acute condition which needs treatment; does not suffer from metabolic stress, infection or inflammation; does not suffer from abnormal liver or kidney function; without any history of heart disease; does not take estrogen and progesterone; does not suffer from poly cyctic ovarian syndrome; not be pregnant or does not lactating.
Exclusion criteria:; meet any aforementioned condition which can exclude the participants from the study ; present any changes in the diet or physical activity.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
A stratified randomized permuted block (with block size randomly varied between 2 or 4) was generated by a biostatistician.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Enqelab Street
City
Tehran
Postal code
Approval date
2015-02-01, 1393/11/12
Ethics committee reference number
93-04-161-27760
Health conditions studied
1
Description of health condition studied
Overweight and obesity
ICD-10 code
E66.9
ICD-10 code description
Simple obesity NOS
Primary outcomes
1
Description
IL-6
Timepoint
30 days
Method of measurement
IL-6 was measured by ELISA kits (BioCore, Germany)
2
Description
MDA
Timepoint
30 days
Method of measurement
IL-6 was measured by ELISA kits (BioCore, Germany)
Secondary outcomes
1
Description
hs-CRP
Timepoint
30 days
Method of measurement
ELISA method using using commercial ELISA kit (Biochem, Ontario, Canada)
2
Description
Glucose
Timepoint
30 days
Method of measurement
determined through an enzymatic calorimetric method using glucose oxidase by commercial kits (Pars azmoon, Tehran, Iran)
3
Description
Cholestrol
Timepoint
30 days
Method of measurement
determined through an enzymatic calorimetric method using glucose oxidase by commercial kits (Pars azmoon, Tehran, Iran)
4
Description
HDL-C
Timepoint
30 days
Method of measurement
determined through an enzymatic calorimetric method using glucose oxidase by commercial kits (Pars azmoon, Tehran, Iran)
5
Description
LDL-C
Timepoint
30 days
Method of measurement
determined through an enzymatic calorimetric method using glucose oxidase by commercial kits (Pars azmoon, Tehran, Iran)
6
Description
Insulin
Timepoint
30 days
Method of measurement
determined through an enzymatic calorimetric method using glucose oxidase by commercial kits (Pars azmoon, Tehran, Iran)
Intervention groups
1
Description
Intervention group:
In the intervention group 1000 mg pomegranate extract through two capsules one of each had 500 mg was consumed daily for 30 days.
Category
Other
2
Description
Control group:
In the control group, 1000 mg identical placebo made by pure crystalline was consumed daily through two capsules one of each had 500 mg placebo for 30 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Saedi
Street address
North Karegar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Enqelab Street
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 for research of 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
Dr. Ahmad Saedi
Position
Associate professor
Other areas of specialty/work
Street address
Enqelab Street
City
Tehran
Postal code
Phone
+98 21 8895 5805
Fax
Email
a_saedi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Saedi
Position
Associate Professor
Other areas of specialty/work
Street address
Enqelab Sreet
City
Tehran
Postal code
Phone
+98 21 8895 5805
Fax
Email
a_saedi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Saedi
Position
Associate Professor
Other areas of specialty/work
Street address
Enqelab Street
City
Tehran
Postal code
Phone
+98 21 8895 5805
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)