The effect of combined training and L-arginine ingestion on the serum levels of Adropin, VEGFR-2 and intercellular and vascular adhesion molecules in postmenopausal hypertensive women
The effect of combined training and L-arginine consumption on serum levels of adropine, VEGFR-2 and cellular and vascular adhesion molecules in postmenopausal women with hypertension.
Design
The study is a double-blind, randomized, factorial clinical trial. The target population includes 40 hypertensive postmenopausal women who will be divided into four groups of 10 people.
Subjects in the combined exercise group will practice for 8 weeks and three sessions per week. Resistance training will include a set of 15-20 repetitions and the endurance training program will include 20 minutes of walking or running per session. The intensity of the endurance training program is 75-60% of the maximum heart rate. L-arginine supplementation will be taken daily at a rate of 6 grams (three 2-gram servings) by L-arginine and exercise + L-arginine subjects (after breakfast, lunch and dinner) and at the same time by placebo subjects. They take a placebo (white flour capsule).
Settings and conduct
Given that the placebo and L-arginine supplement inside the capsule are quite similar participants and researchers are informed of the type of supplement received are not. Sports exercises are performed in Valiasr Sports Club in Tehran.
Participants/Inclusion and exclusion criteria
Women in the age group of 50 to 60 years who are menopausal and have high blood pressure. Do not have other cardiovascular diseases and have no restrictions on physical activity. Do not have drug or alcohol addiction.
Intervention groups
Subjects after filling out the individual consent form to participate in the research simple random (based on a table of random numbers into four groups10 people: 1. Placebo group 2. L-arginine supplement group 3. Combined exercise group 4. Combined exercise group + L-arginine supplement are divided
Main outcome variables
Adropin,VEGFR-2,ICAM-1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210627051723N1
Registration date:2021-07-03, 1400/04/12
Registration timing:prospective
Last update:2021-07-03, 1400/04/12
Update count:0
Registration date
2021-07-03, 1400/04/12
Registrant information
Name
Rozita Nourbakhsh
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 26 3440 3642
Email address
rozita.phd.1355@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-16, 1400/04/25
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined training and L-arginine ingestion on the serum levels of Adropin, VEGFR-2 and intercellular and vascular adhesion molecules in postmenopausal hypertensive women
Public title
The effect of combined exercise and L-arginine on adropine, VEGFR-2 and adhesive molecules in hypertensive postmenopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women 50 to 60 years old with menopause confirmed by a doctor
Confirmation of hypertension
No other cardiovascular diseases
Not participating in regular physical activity in the past year
Exclusion criteria:
Having type 2 diabetes
Restrictions on physical activity
Drug or alcohol addiction
Age
From 50 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects 'names are written on separate sheets of paper and placed in a container, then the subjects' names are randomly taken out and placed in the intervention or placebo group. The first 30 names are placed in the intervention group and the rest in the placebo gro
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the error caused by the awareness of the participants and the researcher Study on the type of treatment received and its possible impact on the research outcomeWe do it blindly in two directions.Because the placebo and L-arginine supplement are placed inside the capsule in exactly the same way, participants and researchers are not aware of the type of supplement they receive.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Physical Education and Sports Sciences, University of Tehran
Street address
Thirteenth floor, Block A, Central headquarters of the Ministry of Health, Qads town
City
Tehran
Province
Tehran
Postal code
3144685543
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.UT.SPORT.REC.1400.005
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Adropin
Timepoint
First, the end of the study
Method of measurement
Kit Elisa
2
Description
VEGFR-2
Timepoint
First, the end of the study
Method of measurement
Kit Elisa
3
Description
ICAM-1
Timepoint
First, the end of the study
Method of measurement
Kit Elisa
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
First,the end of the study
Method of measurement
Mercury blood pressure monitor
2
Description
Diastolic blood pressure
Timepoint
First,the end of the study
Method of measurement
Mercury blood pressure monitor
Intervention groups
1
Description
Intervention group: L-arginine supplement group (L-arginine supplement daily and at a dose of 6 grams (three servings of 2 grams.)
Category
Prevention
2
Description
Combined exercises will be performed for 8 weeks and three sessions per week. First, resistance training and a few minutes later, endurance training will be performe.)
Category
Prevention
3
Description
Intervention group: Combined training group + L-arginine supplement (combined training will be performed for 8 weeks and three sessions per week. First, resistance training and a few minutes later, endurance training.At the same time, L-arginine supplement is taken daily and in the amount of 6 grams (three meals of 2 grams) every day.)
Category
Prevention
4
Description
Control group:Placebo group (not participating in exercise and taking placebo. For 8 weeks, taking L-arginine-like capsules with white flour content (placebo) in the morning, evening and night, made by Darogostar company, in addition to daily activities of life.)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Hendesi Blood Pressure Treatment Clinic
Full name of responsible person
Nourbakhsh Rozita
Street address
Next to Erfan Hospital, Shahrdari Square, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998684911
Phone
+98 21 3441 6041
Email
Rozita.nourbakhsh@yahoo.ca
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Ravasi Ali Asghar
Street address
In front of the university dormitory, Amirabad, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8874 7884
Email
aaravasi@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tehran
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
The University of Tehran
Full name of responsible person
Nourbakhsh Rozita
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 2/1, Shabnam Alley, Mahan Blvd,Jahanshahr
City
Karaj
Province
Alborz
Postal code
3146685543
Phone
+98 21 3441 6041
Fax
Email
rozita.phd.1355@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Ravasi Ali Asghr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
In front of the university dormitory, Amirabad, North Kargar Street
City
Tehran
Province
Tehran
Postal code
3146685543
Phone
+98 21 3441 6041
Fax
Email
rozita.phd.1355@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Nourbakhsh Rozita
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 2/1, Shabnam Alley, Mahan Blvd,Jahanshahr
City
Karaj
Province
Alborz
Postal code
3146685543
Phone
+98 21 3441 6041
Fax
Email
rozita.phd.1355@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
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