Evaluation of the effect of Hesperidin supplementation on the serum levels of inflammatory markers (E-selectin, Interlukin 6, hs-CRP) and Adipocytokines (leptin and adiponectin) in patients with myocardial infarction
A randomized, double-blind, placebo-controlled clinical trial was conducted to investigate the effects of 600 mg pure hesperidin supplements on the serum levels of inflammatory markers and adipocytocines in myocardial infarction patients.All subjects were asked for blood collection, evaluated of anthropometric indices and dietary intakes at the beginning of the present study.Next, 60 MI patients by randomized block allocation were divided into two groups (intervention: n=30, and control: n=30). For the subjects in the intervention group, one capsule included 600 mg pure hesperidin was provided to consume in the morning with breakfast every day for 4 weeks. On the other hand, the control group received on placebo capsule that was similar the color and shape of hesperidin capsule but included 600 mg starch, for 4 weeks. All subjects were instructed to continued their habitual diets and were taking no vitamin/mineral supplements or flavonoid-rich beverages during the study. They also were asked to take these supplements in the morning with breakfast. In the middle of study, dietary intakes were measured. In addition, Anthropometric indices and dietary intakes were evaluated at the end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100210181N2
Registration date:2013-11-27, 1392/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-27, 1392/09/06
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Hesperidin supplementation on the serum levels of inflammatory markers (E-selectin, Interlukin 6, hs-CRP) and Adipocytokines (leptin and adiponectin) in patients with myocardial infarction
Public title
Evaluation of the effect of Hesperidin supplementation in patients with myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were patients with myocardial infarction, being in the range of 40-65 years old, having body mass index (BMI) from 18.5-30 and patients satisfaction. Exclusion criteria included chronic disease (such as Hepatic disorders, Renal failure, diabetes, et.al.), Gastrointestinal disorders, major psychiatric disorder, taking antidepressants,absolute vegetarian diet, consumption of antioxidant and vitamin supplements at least 6 month before sampling,High consumption of flavonoid-rich beverages (including green tea, coffee, Juice, et.al.), smoking, allergies to any vitamin supplements, lack of patient follow-up and lack of consent.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ETH-569
Health conditions studied
1
Description of health condition studied
Myocardian infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
IL-6
Timepoint
before intervention and after one month intervention
Method of measurement
plasma levels
2
Description
hs-CRP
Timepoint
before intervention and after one month intervention
Method of measurement
plasma levels
3
Description
leptin
Timepoint
before intervention and after one month intervention
Method of measurement
plasma levels
4
Description
adiponectin
Timepoint
before intervention and after one month intervention
Method of measurement
plasma levels
5
Description
e-selectin
Timepoint
before intervention and after one month intervention
Method of measurement
plasma levels
Secondary outcomes
1
Description
physical activity
Timepoint
before and end of intervention
Method of measurement
IPAQ questionaire
2
Description
anthropometric indices
Timepoint
before and end of intervention
Method of measurement
meter and scale balance
3
Description
dietary assessment
Timepoint
before, middle and end of intervention
Method of measurement
The three-day, 24-hour food recall
Intervention groups
1
Description
For the subjects in the intervention group, one capsule included 600 mg pure hesperidin was provided to consume in the morning with breakfast every day for 4 weeks
Category
Treatment - Drugs
2
Description
the control group received on placebo capsule that was similar the color and shape of hesperidin capsule but included 600 mg starch,in the breakfast for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital in Ahvaz
Full name of responsible person
Dr. Habib Heibar
Street address
Golestan, Golestan Hospital in Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition and Metabolic Diseases Reearch Center in Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Dr. Majid Karandish
Street address
Ahvaz Jundishapur University of Medical sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition and Metabolic Diseases Reearch Center in Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Haidari
Position
Ph.d of Nutrition
Other areas of specialty/work
Street address
Paramedical school of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1373 8383
Fax
Email
haidari58@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Haidari
Position
Ph.d of Nutiriton
Other areas of specialty/work
Street address
Paramedical school of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1373 8383
Fax
Email
haidari58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Haidari
Position
Ph.d of Nutrition
Other areas of specialty/work
Street address
Paramedical school of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+61 13738382
Fax
Email
haidari58@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)