The effect of beetroot juice (nitrate supplement) on functional capacity of overweight women.
Design
Clinical trial with control group, double blind, randomized by random number table.
Settings and conduct
Aerobic test with basic RAMP protocol and strength test of chest press and leg press with 70% of maximum strength is taken. At the end, RPE is recorded with using a visual questionnaire . At the next visit, patients drink juice (one group of colored water as a placebo and the other group of beetroot juice) 2.5 hour before the test and then the RAMP test and the strength test of the chest press and foot press are taken again.
Participants/Inclusion and exclusion criteria
1-Women with BMI 25 to 29.9 kg per m^2; 2- Age range 45-20 years old; 3- Physical activity less than 90 minutes with moderate intensity per week in at least the last three months; 4- No history of disease (uncontrolled diabetes, severe cardiovascular disease, musculoskeletal limitations and exercise-limiting neurological disorder, uncontrolled hypertension, chronic obstructive pulmonary disease).
Intervention groups
In the case group, beetroot juice and in the control group, water is dyed with food colors is given to samples.
Main outcome variables
Time to get fatigue on the treadmill; Number of repetitions of chest press until fatigue; Number of repetitions of leg press until fatigue; Understanding the difficulty of working while running on a treadmill.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201203049583N1
Registration date:2020-12-15, 1399/09/25
Registration timing:prospective
Last update:2020-12-15, 1399/09/25
Update count:0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Mina Najmabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 3257
Email address
najmabadi.mina@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of beetroot juice supplementation on functional capacity in overweight women
Public title
The effect of beetroot juice supplementation on functional capacity in overweight women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women with BMI 25 to 29.9 kg/m^2
Age range: 20-45 years old
Physical activity less than 90 minutes with moderate intensity per week in at least the last three months
No history of disease (uncontrolled diabetes, severe cardiovascular disease, musculoskeletal limitations and exercise-limiting neurological disorder, uncontrolled hypertension, chronic obstructive pulmonary disease)
Exclusion criteria:
Creating restrictive musculoskeletal problems that prevent continued physical activity
The presence of signs and symptoms that put a person at high risk for heart disease
Reluctance to continue cooperation
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Women with inclusion criteria, after entering, are numbered in order and then identified by numbers.
At the first visit, each sample is entered into one of the two case and control groups by a table of random numbers
Even numbers are in one group and odd numbers are in another
Numbering and division into two groups without coordination with the patient
Blinding (investigator's opinion)
Double blinded
Blinding description
One group is given of colored water (with authorized food colors) as a placebo and the other group is given beetroot juice, and this process is done by a person other than the researcher who is responsible for collecting data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical science
Street address
Building No. 1 of the Faculty of Medicine, First Floor, Office of the Vice Chancellor for Research, North Door of the University, Poursina St., Ghods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2020-04-15, 1399/01/27
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.076
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional capacity ( Time to exhaustion in activity)
Timepoint
Initial referral and referral on the 7th and 14th day
Method of measurement
Borg scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the initial referral, how to perform and how to test is explained. In the second visit, the fatigue time test is performed using the Ramp protocol. 1RM test was taken for chest and leg presses. People are taught not to exercise 12 hours before the aerobic function test and to have breakfast two hours before the test, to avoid diuretics and alcohol at least 12 hours before the test, to use substances such as caffeine and chocolate. Limit 24 hours before the test. Tests are taken between 8 and 10 am. At the end of the test, the difficulty of understanding the work is recorded by the previously trained Borg visual index. The strength test was then performed at 70% 1RM in two sets with as many repetitions as they could perform, two minutes apart. At the end of each test, the perception of difficulty was recorded by the Borg visual index. 1RM is taken from patients by observing the above points
Category
Treatment - Other
2
Description
Control group: The initial referral explains how to do and how to test. In the second visit, the fatigue time test is performed using the Ramp protocol. 1RM test was taken for chest and leg presses. People are taught not to exercise 12 hours before the aerobic function test and to have breakfast two hours before the test, to avoid diuretics and alcohol at least 12 hours before the test, to use substances such as caffeine and chocolate. Limit 24 hours before the test. Tests are taken between 8 and 10 am. At the end of the test, the difficulty of understanding the work is recorded by the previously trained Borg visual index. The strength test was then performed at 70% 1RM in two sets with as many repetitions as they could perform, two minutes apart. At the end of each test, the difficulty of understanding the work was recorded by the Borg visual index. RAMP test, chest press and leg press with 70% 1RM will be taken from patients by observing the above points.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mina Najmabadi
Street address
The end of Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 8081
Email
imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
corner of Quds Street, University Central Organization, 6th floor, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mina Najmabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Department of Sports Medicine, Imam Khomeini hospital, Dr Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Fax
Email
najmabadi.mina@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Najmabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Department of Sports Medicine, Imam Khomeini hospital, Dr Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Fax
Email
najmabadi.mina@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Najmabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Department of Sports Medicine, Imam Khomeini hospital, Dr Gharib Ave., End of Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Fax
Email
najmabadi.mina@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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available