Clinical trial of the effect of curcumin supplementation plus resistance training compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's
The aim of this study is to determine the effects of curcumin supplementation plus resistance training compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's.
Design
This study is a open labeled randomized controlled clinical trial.
Settings and conduct
Neurology clinic of Shahid Beheshti hospital, Kashan, Iran
Sport club, Kashan, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Grade 2 and 3 Parkinson disease patients ; aged 18 to 50
Exclusion criteria:
1- Patients suffering from cardiovascular, hepatic, or kidney diseases,
2- Patients taking antioxidant and/or anti-inflammatory supplements.
3- People who had regular exercise at least 3 1 month before this trial.
4- People who smoke.
5- patients with hypo/hyperthyroidism or any other metabolic disorders.
Intervention groups
1- Intervention group; intake 2 curcumin capsules per day (1000 mg/day) for 8 weeks.(n=10)
2- Intervention group; have resistance training 3 times per week for 8 weeks.(n=10)
3- Intervention group; have resistance training 3 times per week and intake 2 curcumin capsules per day (1000 mg/day)for 8 weeks.(n=10)
4- Control group; intake placebo ( 2 capsule per day). (n=10)
Main outcome variables
Clinical status of patients assessed by Unified Parkinson's Disease Rating Scale (UPDRS) questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045968N1
Registration date:2020-07-20, 1399/04/30
Registration timing:retrospective
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
Registrant information
Name
Zahra Zabihi Rezaei
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 3545
Email address
std_zahra.zabihi@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of curcumin supplementation plus resistance training compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's
Public title
The effect of curcumin supplementation plus resistance training in treatment of patients with Parkinson's
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Parkinson's
Aged 50 to 80 years
Exclusion criteria:
Taking antioxidants supplements
Taking anti-inflammatory supplements
Depression
Severe psychosis
hypo- and hyperthyroidism
Smoking
Consuming curcumin supplements within 3 month prior to the study
Restrictions to practicing exercise, including cardiovascular disease, stroke, respiratory problems and any surgical procedures for the treatment of PD e.g., deep brain stimulation (DBS).
Motor deficits that could limit performance in exercise in the study
Practicing any regular physical activity except for resistance training in the study.
Age
From 50 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline, participants based on balanced blocked randomization will be allocated into four groups to take either curcumin supplementation plus resistance training (n=10), curcumin supplementation (n = 10), resistance training (n=10) or placebo (n = 10). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
The patients and researchers have direct connection in order to performing the exercises thus, this study is not blinded. This work is a open labeled study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kharazmi University
Street address
Kharazmi University, South Moffateh st, Tehran
City
Tehran
Province
Tehran
Postal code
1571914911
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.KHU.REC.1398.028
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Unified Parkinson's disease rating scale
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Physical Examination by Neurologist
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
ELISA kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Calculation using HOMA formula
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Glutathione
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
500 mg curcumin capsule ( contain 450 mg turmeric powder and 50 mg tumeric concentration equivalent with 47.5 mg curcumin) twice a day, for 8 weeks. Exercises are designed in format of 3 circles in each session. The main exercise will be designed with variable intensity suitable with person's ability. The equipment includes leg extension and flexion machine, under hand cable pull down, chest press, shoulder press, elbow extension and flexion machine. The exercises are designed for 3 times per week ( 60 min for each time) for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Resistance training (three times a week) for 8 weeks.
Category
Treatment - Other
3
Description
Intervention group: 500 mg curcumin capsule twice a day plus resistance training (three times a week) for 8 weeks.
Category
Treatment - Other
4
Description
Control group: Without resistance training and the consumption of curcumin supplementation
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Neurology Clinic
Full name of responsible person
Dr Reza Daneshvar
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
daneshvar-r@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Jamshid Shanbehzadeh
Street address
South Mofatteh Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 8607 0779
Email
jamshid@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi University
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
Kharazmi University
Full name of responsible person
Pejman Motamedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
South Mofatteh Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 26 3451 2001
Email
Pezhman.Motamedi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Pejman Motamedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
South Mofatteh Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 26 3451 2001
Email
Pezhman.Motamedi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Zahra Zabihi Rezaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
South Mofatteh Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 26 3455 0702
Email
Std_zahra.zabihi@khu.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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