1) Achieve a balanced diet for patients with Parkinson disease.
2) Achieve the proper intake way of protein and the right time to use protein substances in order to avoid interference with Levodopa. And also help patients to improve.
3) Eliminate the limitations in order to increase drugs effect and patients amelioration.
Design
The clinical trial conducted with two groups, the control, and parallel, blind and randomized group.
The total sample size is 34 which was equally divided into two groups.
Settings and conduct
The location of the study is Alzahra hospital in Isfahan, after selection of patients, all of the required blood tests will be taken and the diet questionnaire will be completed. The primary evaluation of patients based on UPDRS index and they will be divided into control and intervention group by randomized sampling. After all, the expected diet will be determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Staphylococcus aureus 3-1without another neurological disease.
Exclusion criteria: Patients with secondary Parkinson disease following usage of antipsychotics, patients with hypothyroidism, patients with fetal bone marrow syndrome, those with BMI less than 18.5 and patients whose serum albumin, pre-albumin and serum homocysteine are below the normal threshold and those who follow a particular diet.
Intervention groups
Intervention group: Protein intake of the intervention group reduced to 10%. Overall protein intake divided into 30% throughout the day and 70% in the dinner meal.
Control group: The protein intake is reduced to 10% and is consumed without time constraints overnight
Main outcome variables
Reduction of motor disorders and changes in patient's serum proteins.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180203038593N1
Registration date:2019-01-07, 1397/10/17
Registration timing:prospective
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
hossein khalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5752 2676
Email address
khalilyhosien@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect evaluation of diet with different protein distribution on motor function and serum proteins of patients with Parkinson in Esfahan.
Public title
Effect evaluation of diet with different protein distribution on motor function and serum proteins of patients with Parkinson in Esfahan.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with Parkinson disease which are at stage 1 to 3 without any other neurological disease.
Exclusion criteria:
The patients with secondary Parkinson disease following antipsychotic drugs.
Patients with hypothyroidism.
Patients with fetal bone syndrome.
Patients with BMI less than 18.5.
Patients with serum albumin, pre-albumin and serum homocysteine under the normal threshold.
Patients with special food diet and people who opt out of the study.
Patients who avoided to participate in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Sample randomization of patients and divided them into two groups of control and intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The information of patients will be encoded and the participants will be randomly blinded without knowing the group in which they are located.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Shohadaye gomnam blvd., Aalam sq.
City
Yazd
Province
Yazd
Postal code
8571113741
Approval date
2617-12-20, 1996/09/29
Ethics committee reference number
IR.SSU.SPH.REC.1396.132
Health conditions studied
1
Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Motor disfunction
Timepoint
beginning of the study - end of the study
Method of measurement
Unified Parkinson’s Disease Rating Scale (UPDRS)
2
Description
Serum proteins
Timepoint
beginning of the study - end of the study
Method of measurement
Blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Protein intake of the intervention group reduced to 10%. Overall protein intake divided into 30% throughout the day and 70% in the dinner meal.
Category
Lifestyle
2
Description
Control group: The protein intake is reduced to 10% and is consumed without time constraints overnight.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Ahmad Chitsaz
Street address
Alzahra Hospital., Soffeh Blvd., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Email
chitsaz@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Yazd University of Medical Sciences
Street address
Yazd University of Medical Sciences., Shohadaye Gomnam Blvd.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
sphealht@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hossein khalili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
No.25, Pardis Ave., Enghelab street.
City
Afus
Province
Isfehan
Postal code
8571113741
Phone
+98 31 5751 2676
Email
khalilyhosien@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Fateme Kaseb
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Educational Complex., Student Blvd.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3624 0691
Email
fkaseb@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossein khalili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
No. 25, Pardis Ave., Enghelab street.
City
Afus
Province
Isfehan
Postal code
8571113741
Phone
+98 31 5751 2676
Email
khalilyhosien@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The final report of the study will be shared by regional and foreign journals.
When the data will become available and for how long