This study was designed to evaluate the effects of hesperidin supplementation on depressive symptoms, serum levels of BDNF and cortisol in patients with myocardial infarction. This study is a double blind randomized clinical trial in 70 patients 70-30 who rated their symptoms of depression after myocardial infarction is more than 10 on the Beck Depression Inventory. Participants will be divided into two groups (intervention group: 35 Control group: 35).The intervention group consumed hesperidin supplements at a dose of 200 mg per day with one of the main meals for 12 weeks and The control group consumed a placebo capsule daily, who do the same shape and color supplements of hesperidin, but contains 200 mg starch for 12 weeks.Asked everyone to continue their normal diet and not to use any vitamin supplements during the study or drinks rich in flavonoids. Symptoms of depression were measured at the beginning and end of the study by Beck questionnaire and BDNF and cortisol serum levels measured at the beginning and end of the study by taking 10 cc of blood after 14-12 hours of fasting. In order to control confounding factors, will be evaluated at the beginning and end of the intervention levels of physical activity by questionnaire, physical activity and dietary intake by questionnaire Feed International.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702262394N36
Registration date:2017-04-26, 1396/02/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-26, 1396/02/06
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hesperidin supplementation on depressive symptoms, serum levels of BDNF and cortisol in patients after myocardial infarction
Public title
The effect of hesperidin in myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to cooperate and signed informed consent; Do not use any supplements during the last 3 months; including omega-3, 10 Q, antioxidants and vitamins; The absence of any allergies (gastrointestinal and skin) to any type of antioxidant supplements and vitamins, age 30 to 70 years; Beck Depression Inventory score more than 10; patients with MI from discharge to 6 weeks after MI; Do not use more than one blood orange or Do not use more than two other citrus fruits a day; BMI=25-40. Criteria of excluding: There are major psychiatric disorders in patients with history; treatment of depression over 1 year ago; taking more than 500 ml per day of flavonoid-rich beverages include tea, coffee, citrus juice; Major cognitive disorders or impaired cognitive function of the patient's history; Lack of follow-up after discharge; Smoking and tobacco; uncontrolled development of metabolic diseases; Pregnancy and lactation; Use heparin and warfarin. Exclusion criteria: The use of any antioxidant and vitamin supplements; View the latest allergy symptoms at any time during the study; unwillingness to continue the cooperation of the patient for any reason; uncontrolled chronic diseases ( Like: hepatic failure, renal failure, diabetes, etc.); digestive disorders; compliance below 80%; Earn each of the criteria of entry.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences Ethics Committee, Besides Milad Tower, Hemmat, Tehran
City
Tehran
Postal code
1449614535
Approval date
2017-02-22, 1395/12/04
Ethics committee reference number
IR.IUMS.REC 1395.9321323003
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, after the intervention
Method of measurement
Beck standard questionnaire
Secondary outcomes
1
Description
Brain-Derived Neurotrophic Factor
Timepoint
Before the intervention, after the intervention
Method of measurement
ng per ml in the ELISA
2
Description
Cortisol
Timepoint
Before the intervention, after the intervention
Method of measurement
micrograms per deciliter, ELISA
Intervention groups
1
Description
Intervention group: supplements of hesperidin, capsules 200 mg orally, once a day for three months
Category
Treatment - Drugs
2
Description
Control group: placebo containing starch, 200 mg capsules orally, once a day for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Baqiyatallah
Full name of responsible person
Doctor Mohamahosein Najafi
Street address
Hospital Baqiyatallah, the intersection of Sheikh Bahai, Molla Sadra Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Doctor Shima Jazayeri
Street address
Vice chancellor for research, Iran University of Medical Sciences, Besides Milad Tower, Hemmat, Tehran
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, Iran 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
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
PhD Nutrition Sciences
Other areas of specialty/work
Street address
Vice chancellor for research, Iran University of Medical Sciences, Besides Milad Tower, Hemmat, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Fax
+98 21 8862 2707
Email
rezavafa@yahoo.com
Web page address
http://www.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Doctor Shima Jazayeri
Position
P.H.D
Other areas of specialty/work
Street address
Vice chancellor for research, Iran University of Medical Sciences, Besides Milad Tower, Hemmat, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Fax
+98 21 8862 2707
Email
Jazayeri.sh@iums.ac.ir; sh_jaz@yahoo.com
Web page address
http://www.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Atie Sadat Khorasanian
Position
Graduate student, Public health in nutrition
Other areas of specialty/work
Street address
Vice chancellor for research, Iran University of Medical Sciences, Besides Milad Tower, Hemmat, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Fax
+98 21 8862 2707
Email
atie.khorasanian@yahoo.com
Web page address
http://www.iums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)