The aim of this study was to determine the effect of the Mediterranean diet on disease severity and total antioxidant capacity in patients with Parkinson disease
Design
Clinical trial, randomized, parallel study
Settings and conduct
80 patients with Parkinson's disease referred to Neurology clinic of Al-Zahara hospital in Isfahan were selected and randomly assigned to two experimental and control groups. Patients in the experimental group receive Mediterranean diet for 10 weeks the control group received no intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: idiopathic Parkinson's disease (based on the criterion (H & Y); ages 40 and older. Exclusion criteria: psychological problems (cognitive problems); failure to complete the consent form; failure to follow the Mediterranean diet and mortality during the intervention period.
Intervention groups
Patients with Parkinson's disease are randomly assigned to experimental and control groups. Patients in the experimental group receive the Mediterranean diet for 10 weeks. No control is conducted in the control group.
Main outcome variables
Effect of Mediterranean diet on disease severity using the Unified Parkinson Disease Rating Scale (UPDRS) scale and total antioxidant capacity (TAC) serum Is checked.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019853N4
Registration date:2018-12-05, 1397/09/14
Registration timing:retrospective
Last update:2018-12-05, 1397/09/14
Update count:0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Zamzam Paknahad
Name of organization / entity
Isfahan University Of Medical Scences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3166
Email address
paknahad@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2017-05-20, 1396/02/30
Actual recruitment start date
2017-04-30, 1396/02/10
Actual recruitment end date
2017-05-20, 1396/02/30
Trial completion date
2017-07-19, 1396/04/28
Scientific title
The effect of Mediterranean diet on severity of disease and serum Total Antioxidant Capacity (TAC) in patient with Parkinson’s disease
Public title
Effect of Mediterranean diet in Parkinson disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Cases of idiopathic Parkinson's disease (based on criteria (H & Y)
Age of illness over 40 years
Exclusion criteria:
Mental illness (cognitive problems)
Failure to complete the consent form
Failure to follow the Mediterranean diet during the intervention period
Death
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with random numbers extracted from the statistical software excel
Blinding (investigator's opinion)
Single blinded
Blinding description
The data collection team and those who evaluate the outcome were kept blind in the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
IR.MUI.REC.1395.3.735
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Hemiparkinsonism Paralysis agitans Parkinsonism or Parkinson disease: NOS idiopathic primary
Primary outcomes
1
Description
Unified Parkinson Disease Rating Scale
Timepoint
Before and after intervention
Method of measurement
Questionnaire
2
Description
Total Antioxidant Capacity (TAC)
Timepoint
Before and after intervention
Method of measurement
ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:Patients in the experimental group receive Mediterranean diet for 10 weeks.
Category
Lifestyle
2
Description
Control group: In the control group received no intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of Al-Zahara hospital in Isfahan
Full name of responsible person
Dr Ahmad Chitsaz
Street address
Safeh Boulevard - Al-Zahra Educational Center
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
+98 31 1668 4510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Zamzam Paknahad
Position
Ph.D of Nurition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 317923166
Fax
Email
paknahad@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zamzam Paknahad
Position
Ph.D of Nurition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 317923166
Fax
Email
paknahad@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Zamzam Paknahad
Position
PhD of Nurition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 317923166
Fax
Email
paknahad@hlth.mui.ac.ir
Web page address
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