The effect of quercetin supplementation on antioxidant and inflammatory factors after the exhaustive progressive aerobic exercise in premenstrual syndrome in active young females
The effect of a course of quercetin supplementation on antioxidant, inflammatory factors and sex hormones after the implementation of increasing aerobic activity in active young women with premenstrual syndrome.
Design
The current research is applied, semi-experimental and laboratory. The research design is in the form of pre-test and post-test in a crossover method with a 3-week washing period
Settings and conduct
The participants are cross-over and equally placed in two placebo groups along with Bruce's maximal aerobic test and supplemented with Bruce's maximal aerobic test with a 3-week washout period. The study subjects are studied during 3 months in the last week of their luteal phase. Both the placebo and supplement groups have blood sampling once before the Bruce test and once immediately after the Bruce test. The second and third blood sampling is done after the Bruce test.
Participants/Inclusion and exclusion criteria
1-- Active young women with at least 6 months of sports activity experience 2- Having a regular menstrual cycle 3- Having premenstrual syndrome 4- Not having any hormonal and ovarian disease 5- No background, cardiovascular, metabolic, respiratory disease 6- Not having restrictions Physical and functional 7-Non-smoking
Intervention groups
1-Supplement group (one week of supplement use) along with Bruce's maximal aerobic test 2-Placebo group (one week of placebo consumption) along with Bruce's maximal aerobic test
Main outcome variables
Serum levels of glutathione peroxidase - serum levels of superoxide dismutase and CRP - maximal aerobic performance,estrogen and progesterone hormones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241002063245N1
Registration date:2024-11-24, 1403/09/04
Registration timing:registered_while_recruiting
Last update:2024-11-24, 1403/09/04
Update count:0
Registration date
2024-11-24, 1403/09/04
Registrant information
Name
Fatemeh Ehsani
Name of organization / entity
The University of alzahra
Country
Iran (Islamic Republic of)
Phone
+98 31 5542 1852
Email address
mahshidehsani1300@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-10, 1403/08/20
Expected recruitment end date
2025-02-28, 1403/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of quercetin supplementation on antioxidant and inflammatory factors after the exhaustive progressive aerobic exercise in premenstrual syndrome in active young females
Public title
The effect of quercetin supplementation on antioxidant and inflammatory in active young females
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Young and active women with at least 6 months of sports experience
Having premenstrual syndrome
Regular menstrual cycle
Exclusion criteria:
Having any history of hormonal and ovarian disease
Without background, cardiovascular, metabolic, respiratory disease
Having no physical and functional limitations
Non-smoker
Age
From 19 years old to 27 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into one of three groups (Two intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Al-Zahra University
Street address
Al-Zahra University, Deh Vank, Tehran
City
Tehran
Province
Tehran
Postal code
1993891176
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.ALZAHRA.REC.1403.010
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Serum levels of glutathione peroxidase, superoxide dismutase and crp
Timepoint
In 2 times. Before Bruce's maximal aerobic test, fasted and immediately after Bruce's maximal aerobic test
Method of measurement
by blood test
2
Description
Serum levels of estrogen and progesterone hormones
Timepoint
In 2 times. Before Bruce's maximal aerobic test, fasted and immediately after Bruce's maximal aerobic test
Method of measurement
by blood test
Secondary outcomes
1
Description
Maximum aerobic performance
Timepoint
During Bruce's maximum aerobic test
Method of measurement
by Bruce maximum aerobic treadmill test and respiratory gas analysis device
Intervention groups
1
Description
Quercetin supplement in a dose of 1000 mg in two meals for dinner and lunch in capsules containing 500 mg for one week in the period of premenstrual syndrome. After the end of one week, entering Laboratory and blood sampling of the first stage in an fasting state, blood sampling of the second stage immediately after the performance of Bruce's residual aerobic test. The duration of the current research protocol is 3 months, and every month during the period of premenstrual syndrome, the subjects will be taken to the laboratory and the Bruce test will be performed. Supplement from the company Made by SINOPLASAN, Germany. HP Cosmos treadmill will be used to perform the Bruce test.
Category
Treatment - Other
2
Description
Control group: Taking a placebo and performing Bruce's maximum aerobic test.The placebo group, like the control group, will carry out the research protocol by consuming capsules containing dextrose in two meals, breakfast and dinner, and performing blood sampling in the first, second, and third stages. All samples will participate in this research after completing the consent form and health-related questionnaires.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Medical Clinic
Full name of responsible person
Dr Elham Shakoor
Street address
Sheikh Bahai St
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 21 8804 4040
Email
Eli_shakoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Al-Zahra University
Full name of responsible person
Zahra Jafarzadeh
Street address
Deh Vanak Square, Al-Zahra University
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 21 8803 0652
Email
L.ghazaleh@alzahra.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Al-Zahra 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
Al-Zahra University
Full name of responsible person
Dr Leila Ghazale
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanics of the muscle nerve
Street address
Sheikh Bahai Square, Deh Venk Square
City
Tehran
Province
Tehran
Postal code
1993893973
Phone
+98 21 8804 4040
Email
L.ghazaleh@alzahra.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Al-Zahra University
Full name of responsible person
Fatemeh Ehsani
Position
senior student
Latest degree
Master
Other areas of specialty/work
Sports nutrition and physiology
Street address
Sheikh Bahai Square
City
Tehran
Province
Tehran
Postal code
1993893973
Phone
+98 21 8804 4040
Email
Mahshidehsani1300@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Al-Zahra University
Full name of responsible person
Fatemeh Ehsani
Position
senior student
Latest degree
Bachelor
Other areas of specialty/work
Sports nutrition and physiology
Street address
Sheikh Bahai Square
City
Tehran
Province
Tehran
Postal code
1993893973
Phone
+98 21 8804 4040
Email
Mahshidehsani1300@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD