Effect of eight weeks of aerobic exercise and pomegranate juice on some microRNAs and enzymes related to the oxidative / anti-oxidative system of men with prostate cancer
Simultaneous effect of pomegranate juice and aerobic exercise on people with prostate cancer
Design
The clinical trial consisted of three experimental groups and a control group of two phase 2 randomized blind patients on 60 patients. The experimental group includes aerobic exercise group, pomegranate juice consumption group, aerobic exercise group and control group. Pomegranate juice groups consumed pomegranate juice for eight weeks and 6 days each week.
Settings and conduct
The place of this research is in Lorestan province and Khorramabad city. To select the samples, first they will refer to specialized centers and urology offices and then the required samples will be selected according to the inclusion criteria. Study with non-random allocation And without blinding.
Participants/Inclusion and exclusion criteria
1- Do not perform radiation therapy, chemotherapy and androgen therapy
2- Do not perform any surgery
3- Not having any heart disease
4- Do not smoke or drink alcohol
5 - No physical problems such as orthopedic and cerebrovascular problems that prevent exercise.
6- Blood pressure> 110/180 as a criterion for leaving the study process
7- Lack of continuous exercise before starting the exercise program
8-> PSA 6 as a criterion for entering the study process
Intervention groups
In this study, 4 groups include three experimental groups and one control group. The experimental group includes aerobic exercise group, pomegranate juice consumption group, aerobic exercise group and control group. The pomegranate juice groups consumed pomegranate juice for eight weeks and 6 days each week, the aerobic exercise group consumed three sessions of aerobic exercise for 35 weeks and 35 minutes per week on a stationary bike for 75-60 minutes. Percentage of maximum heart rate will work.
Main outcome variables
microRNA-24,microRNA-34,microRNA-155
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200901048588N1
Registration date:2020-11-08, 1399/08/18
Registration timing:registered_while_recruiting
Last update:2020-11-08, 1399/08/18
Update count:0
Registration date
2020-11-08, 1399/08/18
Registrant information
Name
Mahnaz Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3692 3548
Email address
f.fathollahi1984@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-22, 1399/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eight weeks of aerobic exercise and pomegranate juice on some microRNAs and enzymes related to the oxidative / anti-oxidative system of men with prostate cancer
Public title
The effect of pomegranate juice and exercise on prostate cancer
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Failure to perform radiation therapy, chemotherapy and androgen therapy
Do not perform any surgery
> PSA 6 as a benchmark for the study process
Lack of continuous exercise before starting the exercise program
Exclusion criteria:
Perform specialized treatments such as chemotherapy and radiation therapy in the last 6 months
Perform prostate cancer related surgeries
having cardiovascular disease, diabetes and neurological diseases
Alcohol consumption, smoking
Cancer cell metastasis and involvement of other tissues and organs in the body
Age
From 45 years old to 60 years old
Gender
Male
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Khorramabad 5 km Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.LUMS.REC.1399.195
Health conditions studied
1
Description of health condition studied
prostate cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
microRNA-21,microRNA-34,microRNA-155
Timepoint
48 hours before and after eight weeks of aerobic exercise and consumption of pomegranate juice
48 hours before and after the performance, eight weeks of aerobic training and consumption of pomegranate juice
Method of measurement
ELISA device
Intervention groups
1
Description
Intervention group: Aerobic exercise with a work bike, 60 to 90 minutes, 3 sessions per week, for 8 weeks
Category
Prevention
2
Description
Intervention group: Aerobic exercise and pomegranate juice, 60 to 90 minutes of exercise, 3 sessions per week with consumption of 100 cc of pomegranate juice every morning fasting for 8 weeks
Category
Prevention
3
Description
Natural pomegranate juice, 100 cc, every morning fasting, for 8 weeks
Category
Prevention
4
Description
Control group: No aerobic exercise and consumption of pomegranate juice
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
مطب های مربوط متخصصین ارولوژی
Full name of responsible person
مهناز مردانی
Street address
West Goldasht, School of Health and Nutrition
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3340 8176
Email
msmardani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mahnaz Mardani
Street address
Khorramabad 5 km of Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3340 8176
Email
msmardani@yahoo.com
Grant name
Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences
Grant code / Reference number
1588-99-1-1397
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mahnaz Mardani
Position
Professor of Lorestan University of Medical Sciences, Dean of the Faculty of Health and Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Goldasht Gharbi School of Health and Nutrition
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3340 8176
Email
msmardani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mahnaz Mardani
Position
Professor of Lorestan University of Medical Sciences, Dean of the Faculty of Health and Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Goldasht Gharbi School of Health and Nutrition
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3340 8176
Email
msmardani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mahnaz Mardani
Position
Professor of Lorestan University of Medical Sciences, Dean of the Faculty of Health and Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Goldasht Gharbi School of Health and Nutrition
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3340 8176
Email
msmardani@yahoo.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
No - There is not 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