Evaluation the effect of four weeks endurance training and MitoQ supplementation alone and in combination on serum level of some of microRNAs effective on blood pressure and oxidant, antioxidant, inflammatory and on functional cardiac factors in hypertensive patients
Evaluation of the effect of four weeks endurance training and MitoQ supplementation on serum level of some of microRNAs effective on blood pressure and oxidant, antioxidant, inflammatory and on functional cardiac factors in hypertensive patients
Design
The study is parallel and two-blind (researcher and subject) and the allocation of patients to the intervention and control group is randomly simple. (6 groups; n = 60)
Settings and conduct
In a Shafa hospital with a cardiologist, bicycle and blood tests and echo can be done. The researcher and the subject both are unaware of the interventions
Participants/Inclusion and exclusion criteria
Participants and entry criteria: Men 40 to 55 years of age with systolic blood pressure equal to or greater than 140 mm Hg and diastolic blood pressure equal to or greater than 90 mm Hg.
Exit criteria: Liver, kidney, lung, diabetes, certain diseases such as cancer and other cardiovascular diseases
Intervention groups
1) Hypertension (HTN) control: Systolic blood pressure equal to or greater than 140 and diastolic blood pressure equal to or greater than 90 mm Hg
2) HTN with endurance exercise: People with HTN have bicycle endurance training for 4 weeks (3 times a week).
3) HTN with MitoQ Supplement: People with HTN receive a capsule of MitoQ supplemental (20 mg per day for 4 weeks).
4) HTN with placebo: People with HTN receive a placebo capsule MitoQ orally for 4 weeks a day.
5) HTN with MitoQ supplementation and endurance training: Hypertensive individuals undergo a cycling endurance training (3 times per week for 4 weeks), during which time Daily receive one MitoQ orally (20 mg/day).
6) HTN with oral administration of placebo and endurance training: Similar to group 5. They will only receive a placebo instead of a supplement.
Main outcome variables
miR21, 27a, 126, 222 and oxidant, antioxidant, inflammatory factors and on functional cardiac factors (Echo)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190228042870N1
Registration date:2019-04-17, 1398/01/28
Registration timing:prospective
Last update:2019-04-17, 1398/01/28
Update count:0
Registration date
2019-04-17, 1398/01/28
Registrant information
Name
Hamid Najafipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 6839
Email address
najafipourh@yahoo.co.uk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of four weeks endurance training and MitoQ supplementation alone and in combination on serum level of some of microRNAs effective on blood pressure and oxidant, antioxidant, inflammatory and on functional cardiac factors in hypertensive patients
Public title
Evaluation the effect of endurance training and MitoQ supplementation on blood pressure
Liver, kidney, lung, diabetes diseases and certain diseases like cancer
Age
From 40 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants randomly and on the basis of throwing dice into separate groups to compare different treatments by researchers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and all study personnel were blinded to treatment assignment and lipid measurements. Treatments that take place on the participants are impartial and it is not clear which treatment is the best when it comes to clinical testing.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Jihad Bolvd.Ebnsina Ave.Kerman,Iran
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.KMU.REC.1397.595
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
110-115
ICD-10 code description
Hypertensive diseases
Primary outcomes
1
Description
miR-21
Timepoint
At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training
Method of measurement
Real-Time PCR
2
Description
miR-27a
Timepoint
At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training
Method of measurement
Real-Time PCR
3
Description
miR-126
Timepoint
At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training
Method of measurement
Real-Time PCR
4
Description
miR-222
Timepoint
At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training
Method of measurement
Real-Time PCR
5
Description
Blood pressure
Timepoint
before the intervention and Days 1, 3, 5, ... and 28th day
Method of measurement
Sphygmomanometer
6
Description
Percentage of arterial oxygen saturation
Timepoint
Before training, during training, immediately after training and at intervals of 15, 30 and 45 minutes after training
Method of measurement
Pulse Oximeter
7
Description
HDL-c
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
8
Description
Oxidized LDL
Timepoint
before the intervention and 28th day
Method of measurement
Elisa kit
9
Description
Cholestrol
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
10
Description
Triglyceride
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
11
Description
Heart rate
Timepoint
Before training, during training, immediately after training and at intervals of 15, 30 and 45 minutes after training
Method of measurement
Pulse Oximeter
12
Description
Left Ventricular End-Systolic Diamater
Timepoint
before the intervention and 28th day
Method of measurement
Echocardiography
13
Description
Left Ventricular End-diastolic Diamater
Timepoint
before the intervention and 28th day
Method of measurement
Echocardiography
14
Description
Ejection Fraction
Timepoint
before the intervention and 28th day
Method of measurement
Echocardiography
15
Description
Shortening Fraction
Timepoint
before the intervention and 28th day
Method of measurement
Echocardiography
16
Description
superoxide dismutase
Timepoint
before the intervention and 28th day
Method of measurement
Elisa kit
17
Description
Glutathione Peroxidase
Timepoint
before the intervention and 28th day
Method of measurement
Elisa kit
18
Description
Malondialdehyde
Timepoint
before the intervention and 28th day
Method of measurement
Elisa kit
19
Description
Interleukin-6
Timepoint
before the intervention and 28th day
Method of measurement
Elisa kit
20
Description
Hs-CRP
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
21
Description
Creatinine
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
22
Description
Alanine aminotransferase (SGPT)
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
23
Description
Aspartate aminotransferase (SGOT)
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
24
Description
Alkaline Phosphatase
Timepoint
before the intervention and Days 14 and 28
Method of measurement
Biochemical autoanalyzer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Hypertension: People in this study have a systolic blood pressure equal to or greater than 140 mm Hg and a diastolic blood pressure equal to or greater than 90 mm Hg. During the study period, which lasted for 4 weeks, no intervention was performed on They do not accept.
Category
Diagnosis
2
Description
Intervention group: 1); Hypertension group with endurance training: In this group, people with hypertension for 4 weeks (3 times a week), exercise endurance bike with specified strength and depending on the aerobic capacity.
Category
Rehabilitation
3
Description
Intervention group: 2) Hypertension group with MitoQ supplemented oral administration: In this group, people with hypertension receive a supplement of oral MitoQ capsules at a dose of 20 mg/day for 4 weeks a day. MitoQ is a mitochondria-targeted antioxidant(Advanced CoQ10 Formula). MitoQ is produced by MitoQ company (Auckland, New Zealand).
Category
Treatment - Drugs
4
Description
Intervention group: 3) Hypertension group with oral administration of placebo: In this group, people with hypertension receive a placebo capsule of MitoQ daily for 4 weeks a day.
Category
Treatment - Drugs
5
Description
Intervention group: 4) Hypertension group with MitoQ supplement supplementation and endurance training: In this group, people with hypertension have a cycling endurance training for 4 weeks in 3 times per week, and at the same time they receive a daily MitoQ capsule of 20 mg per day. MitoQ is a mitochondria-targeted antioxidant(Advanced CoQ10 Formula). MitoQ is produced by MitoQ company (Auckland, New Zealand).
Category
Treatment - Drugs
6
Description
Intervention group: 5) The group was in hypertension with oral administration of placebo (placebo) and endurance training: In this group, people with hypertension have a cycling endurance training for 4 weeks in 3 times per week, and they receive a single placebo capsule of MitoQ daily for oral administration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Hamidreza Nasri
Street address
Shafa street, Shafa Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
kpr@kmu.ac.ir
Web page address
http://www.kmu.ac.ir/fa/sh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas pardakhti
Street address
Deputy of research and technology, Jahad Blvd, Ebne sina street
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Yaser Masoumi-Ardakani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Physiology Research Center, Deputy of Research and Technology of Kerman University of Medical Sciences, Jahad Blvd, Ebne Sina Street
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3223 6839
Email
ymab125@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yaser Masoumi-Ardakani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Physiology Research Center, Deputy of Research and Technology of Kerman University of Medical Sciences, Jahad Blvd, Ebne Sina Street
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3223 6839
Email
ymab125@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yaser Masoumi-Ardakani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Physiology Research Center, Deputy of Research and Technology of Kerman University of Medical Sciences, Jahad Blvd, Ebne Sina Street
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3223 6839
Email
ymab125@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
Post-publication results will be available as an article to everyone. All data will also be available to the Physiology Research Center
When the data will become available and for how long
Since 1400
To whom data/document is available
Physiology Research Center of Kerman University of Medical Sciences, patients and other researchers
Under which criteria data/document could be used
There is no limit
From where data/document is obtainable
Physiology Research Center of Kerman University of Medical Sciences
What processes are involved for a request to access data/document
Attendance at the center or written request from other universities