This study aimed to determine the effect of 7-day supplementation with Plantago major extract following a single session of high-intensity functional training(HIFT) on selected oxidative stress and muscle damage blood markers in overweight, untrained men. The exercise session lasted 27 minutes and 30 seconds at 80-85% of the participants' maximum heart rate.
Design
A two-armed parallel-group randomized trial, with a double-blind design.
Randomization was performed using the RAND() function in Excel.
Settings and conduct
Location: Laboratory of Faculty of Physical Education and Sports Sciences, Allameh Tabatabai University, Tehran
The participants were randomly assigned to two groups, supplement and placebo, in a double-blind design. After 7 days of supplementation or placebo, they performed an (HIFT) session at 80-85% of their maximum heart rate. the exercise session lasted 27 minutes and 30 seconds. Blood samples were collected at three time points.
Participants/Inclusion and exclusion criteria
A total of 22 sedentary overweight adult men, aged 35 to 50 years, with a BMI between 25 and 29.9 kg/m2,
healthy, and non-smokers
Intervention groups
Supplement group (n=11): Received 6 g/day of Plantago extract for 7 days.
Placebo group (n=11)
Blood samples were collected at:
1. Baseline(T1): Before supplementation.
2. Pre-exercise(T2): After 7 days of supplementation and before exercise.
3. Post-exercise (T3): Immediately after the exercise session.
Main outcome variables
Blood sampling from the serum and indicators of oxidative stress including:
superoxide dismutase(SOD);
malondialdehyde(MDA);
total antioxidant capacity(TAC);
Indicators of muscle damage include:
lactate dehydrogenase(LDH);
and creatine kinase(CK)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241111063676N1
Registration date:2025-03-05, 1403/12/15
Registration timing:retrospective
Last update:2025-03-05, 1403/12/15
Update count:0
Registration date
2025-03-05, 1403/12/15
Registrant information
Name
Neda Rajamand
Name of organization / entity
Allame tabatabaei University
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 2774
Email address
neda.rajamand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-04-27, 1402/02/07
Actual recruitment start date
2023-04-21, 1402/02/01
Actual recruitment end date
2023-04-27, 1402/02/07
Trial completion date
2023-05-04, 1402/02/14
Scientific title
Effect of Plantain Supplementation on exercise-induced Oxidative Stress and Muscle Damage in Overweight Adult Men: A Randomized Controlled Trial
Public title
Effect of Plantain supplementation on oxidative stress and obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abdominal obesity and waist size: above 80 cm
No mental disorders
No history of regular physical activity in the last 6 months
No hormonal treatment
Non-smokers
Physical ability to attend the protocol
No history of surgery in the last 2 years
Absence of skeletal and muscular injuries
Not taking medicine and nutritional and sports supplements
Exclusion criteria:
Weight loss
Consumption of stimulants and energy drinks
Not getting enough fluids
Alcohol consumption
Taking painkillers and anti-inflammatory drugs
Having diabetes and high blood pressure
Taking medicine
Failure to complete exercise
Using a diet outside of the researcher's recommendation
Failure to participate in two test sessions
Age
From 35 years old to 50 years old
Gender
Male
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
22
Actual sample size reached:
22
Randomization (investigator's opinion)
Randomized
Randomization description
This study randomly assigned 22 overweight adult men to either the supplement(Plantago) or placebo group. To control for the potential effect of Body Mass Index(BMI) on the results, participants were first stratified based on their mean BMI and then allocated to one of two study groups using stratified randomization.
Random allocation was performed using Microsoft Excel. First, participants' BMI data were entered into the software. Then, the RAND() function was used to generate a random number for each participant. Based on these random values, participants were randomly assigned to one of the two groups(11 per group) in a way that ensured a nearly equal mean BMI across both groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was conducted in a double-blind manner, meaning that both the participants and the researchers were unaware of the intervention type (supplement or placebo) to minimize bias and ensure the reliability of the results.
On the day of the test, all the executive team members, including the coach, the blood sample collector, the laboratory expert, and the statistician, were unaware of the division of the participants until the time of analyzing the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Allameh tabatabaei University
Street address
No.29,unit10, Sherafati St., Sheikh bahayi Sq.
City
Tehran
Province
Tehran
Postal code
1995734934
Approval date
2023-01-25, 1401/11/05
Ethics committee reference number
IR.ATU.REC.1401.077
Health conditions studied
1
Description of health condition studied
Overweight and Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Serum levels of Superoxid dismutase
Timepoint
before the start of supplementation, seven days after supplementation, and immediately after the exercise session
Method of measurement
Superoxide dismutase serum level measuring kit made in Germany, ZellBio GmbH by ELISA method
2
Description
Serum levels of malondialdehyde
Timepoint
before the start of supplementation, 7 days after supplementation, and immediately after the exercise session
Method of measurement
Malondialdehyde serum level measuring kit made in Germany, ZellBio GmbH by ELISA method
3
Description
Serum levels of total antioxidantcapacity
Timepoint
before the start of supplementation, 7 days after supplementation, and immediately after the exercise session
Method of measurement
Total antioxidant capacity serum level measuring kit made in Germany, ZellBio GmbH by ELISA method
4
Description
Serum levels of Lactate dehydrogenase
Timepoint
before the start of supplementation, 7 days after supplementation, and immediately after the exercise session
Method of measurement
Measurement of Lactate dehydrogenase using NAC.Kinetic UV enzyme kit by Delta Derman Part Company, Made in Iran.
5
Description
Serum levels of Creatine Kinase
Timepoint
before the start of supplementation, 7 days after supplementation, and immediately after the exercise session
Method of measurement
Measurement of creatine kinase using NAC.Kinetic UV enzyme kit by Delta Derman Part Company, Made in Iran.
Secondary outcomes
empty
Intervention groups
1
Description
Plantain extract, provided from plantain seeds, in the form of capsules. Each capsule contains 600 mg of the extract, with a daily dosage of 12 grams (2 capsules/day) half an hour after having breakfast. The Plantago extract was produced by using an industrial reactor through a step-by-step solvent extraction process involving polar solvents (water and ethanol). The extract was then transformed into a powder using a spray dryer. The resulting powdered extract was accurately weighed using a precision balance (with a sensitivity of 0.01 grams) and then capsulated in edible gelatin capsules with adherence to health protocols and standards. Finally, the capsules were sealed and packaged for use by participants.
Category
Treatment - Drugs
2
Description
For the lacebo group, 14 capsules containing 400 mg of maltodextrin were provided for 7 day. Participants were instructed to take two capsules along with a glass of water 30 minutes after brekfast each day. Aside from teh preparation of the capsules, there was no visible difference in the intervention between the study group and the placebo group.
Category
Placebo
3
Description
Intervention Group: HIFT Training SessionThe training protocol consisted of an 8-minute warm-up, 27:30 minutes of exercise activity, and a 5-minute cool-down for all subjects in both the supplement and placebo groups.The exercise was performed as 10 functional movements in a circuit training system (two circuits, each with three sets). Each movement was performed for 30 seconds, followed by 20 seconds of active rest. After every 10 movements (1 set of exercise), subjects had a one-minute rest period. Each circuit was repeated for three sets.To standardize the activity load among participants, weights equivalent to 5% of each individual's body weight were used. Throughout the protocol, subjects were verbally encouraged to perform the movements with maximum speed and repetition.After each exercise circuit, subjects were asked about their Borg Rating of Perceived Exertion (RPE), and the score was recorded. The intensity of the exercises was performed in the range of 80-85% of maximum heart rate, which was monitored in real-time by a heart rate sensor.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Tabtabaei University
Full name of responsible person
Neda Rajamand
Street address
No.29, Unit 10, Sherafati St., Sheikh Bahayi Sq.
City
Tehran
Province
Tehran
Postal code
1995734934
Phone
+98 912 539 2434
Email
Neda.Rajamand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Allameh tabatabaei University
Full name of responsible person
Neda Rajamand
Street address
No.29, Unit10, Sherafati St., Sheikh bahayi Sq.
City
Tehran
Province
Tehran
Postal code
1995734934
Phone
+98 912 539 2434
Email
neda.rajamand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh tabatabaei University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Allame tabatabaei
Full name of responsible person
Neda Rajamand
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.29, Unit10, Sherafati St., Sheikh Bahayi Sq.
City
Tehran
Province
Tehran
Postal code
1995734934
Phone
+98 912 539 2434
Email
neda.rajamand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allame tabatabaei University
Full name of responsible person
Neda Rajamand
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.29, unit10, Sherafati St, Sheikh bahayi Sq.
City
Tehran
Province
Tehran
Postal code
1995734934
Phone
+98 21 8803 2774
Fax
Email
neda.rajamand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Allame tabatabaei University
Full name of responsible person
Neda Rajamand
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No.29, unit10, Sherafati St, Sheikh bahayi Sq.
City
Tehran
Province
Tehran
Postal code
1995734934
Phone
+98 21 8803 2774
Fax
Email
neda.rajamand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be available for publication if necessary and upon request from the corresponding author, supervisor, co-supervisor, and participants.
When the data will become available and for how long
within 5 years
To whom data/document is available
Corresponding author, supervisor, consultant, and participants