The short-term effect of caffeine supplement on changes in myocardial oxygen consumption, heart rate variability, Delayed-Onset Muscle Soreness (DOMS) and rating of perceived exertion in trained young men
The short-term effect of caffeine supplement on changes in myocardial oxygen consumption, heart rate variability, Delayed-Onset Muscle Soreness (DOMS) and rating of perceived exertion in trained young men
Design
A phase 3 randomized with G power software , crossover, single-blind clinical trial was conducted on 12 trained young men.
Settings and conduct
It was done at Gilan University after 8 hours of fasting and sharing breakfast with the same calories and 320 calories. Blinding was performed using tablets and placebo in the supplement and placebo groups.
Participants/Inclusion and exclusion criteria
Young trained men with a history of at least 6 months of regular training with a homogeneous age and weight range
2) Lack of sensitivity and lack of medical contraindications for consuming caffeine and lack of medical contraindications for sports activities
3) No long-term history of caffeine consumption
4) having physical health and no injuries and without special clinical considerations
2) Observation of hypersensitivity to caffeine consumption in the subject (insomnia, restlessness, behavioral changes, irritability and increased heart rate)
Intervention groups
Caffeine supplementation and circuit resistance training
Placebo and circuit resistance training
Main outcome variables
Used for coaches and preventing overtraining of athletes, preventing damage to the cardiovascular system and sudden death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240521061865N1
Registration date:2024-06-17, 1403/03/28
Registration timing:retrospective
Last update:2024-06-17, 1403/03/28
Update count:0
Registration date
2024-06-17, 1403/03/28
Registrant information
Name
Ronak Latifnezhad
Name of organization / entity
Guilan university
Country
Iran (Islamic Republic of)
Phone
+98 918 478 8697
Email address
royaaaloootfi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-19, 1403/01/31
Expected recruitment end date
2024-05-14, 1403/02/25
Actual recruitment start date
2024-04-19, 1403/01/31
Actual recruitment end date
2024-05-14, 1403/02/25
Trial completion date
2024-05-14, 1403/02/25
Scientific title
The short-term effect of caffeine supplement on changes in myocardial oxygen consumption, heart rate variability, Delayed-Onset Muscle Soreness (DOMS) and rating of perceived exertion in trained young men
Public title
The short-term effect of caffeine supplement on changes in myocardial oxygen consumption, heart rate variability, Delayed-Onset Muscle Soreness (DOMS) and rating of perceived exertion in trained young men
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1) young trained men with at least 6 months of regular training with ahomogeneous age and weight range 2) no reduction and no medical prohibition in caffeine consumption and no medical prohibition to perform sports activities 3) no long-term history of caffeine consumption 4) physically healthy and no injuries and no special clinical considerations
Exclusion criteria:
Observing excessive consumption of caffeine in the subject (insomnia, restlessness, behavioral changes, mobility and increased heart rate
Age
From 20 years old to 30 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
SUPPLEMENT and PLACEBO
Actual sample size reached:
12
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
participants, contributors. Lack of knowledge about taking pills or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Guilan
Street address
Qazvin-Rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Approval date
2024-05-18, 1403/02/29
Ethics committee reference number
IR.GUILAN.REC.1403.048
Health conditions studied
1
Description of health condition studied
Effects of caffeine supplementation on cardiac rhythm changes in trained and healthy young men with circuit resistance training
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rhythm song of healthy and trained young men
Timepoint
Variability of heart rate, blood pressure and perception of baseline and post-exercise pressure, delayed concussion up to 72 hours after exercise
Method of measurement
Cubius and Elite HRV software, sphygmomanometer, Borg scale, McGill questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1They ingested caffeine Alhavi Enercaff 200 Capsules made in Iran (4mg/kg) After 8 hours of fasting consumption, participants were monitored throughout a 30minutes ingested period, then complete resistance training with an intensity of 70-80% 1RM, followed by 30 minutes of recovery. Heart rate variability indexes (RMSSD and LF,HF, LF/HF) were taken with Elite HRV and Kubios Software at the baseline, 30 minutes after caffeine ingestion, recovery 1 (0-5 minutes), recovery 2 (5-10)recovery3(15-20 minutes), recovery 4(25-30)pressure product (RPP) were taken at the baseline, pre training and post training minutes after caffeine consumption, immediately after exercis30 minutes of recovery period , rating of perceived exertion (RPE) immediately ,2min,3min,5min and10 minutes of recovery period with Borg scale delayed onset muscle soreness were taken though ROM test, MVC test from Thigh and knee extensor sergeant test and McGill questionnaire for72hours after RT.
Category
Prevention
2
Description
Intervention group: 2Intervention group: 1They ingested placebo tablet Contains elderberry powder (4mg/kg) After 8 hours of fasting consumption, participants were monitored throughout a 30minutes ingested period, then complete resistance training with an intensity of 70-80% 1RM, followed by 30 minutes of recovery. Heart rate variability indexes (RMSSD and LF,HF, LF/HF) were taken with Elite HRV and Kubios Software at the baseline, 30 minutes after caffeine ingestion, recovery 1 (0-5 minutes), recovery 2 (5-10)recovery3(15-20 minutes), recovery 4(25-30)pressure product (RPP) were taken at the baseline, pre training and post training minutes after caffeine consumption, immediately after exercis30 minutes of recovery period , rating of perceived exertion (RPE) immediately ,2min,3min,5min and10 minutes of recovery period with Borg scale delayed onset muscle soreness were taken though ROM test, MVC test from Thigh and knee extensor sergeant test and McGill questionnaire for72hours after RT.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan university
Full name of responsible person
Arsalan Damirchi
Street address
Qazvin-Rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 911 131 3084
Email
damirchi@guilan.ac
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Guilan
Full name of responsible person
Arsalan Damirchi
Street address
Qazvin-rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 911 131 3084
Email
damirchi@guilan.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 Guilan
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University ofGuilan
Full name of responsible person
Ronak latifnezhad
Position
Msc student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Qazvin-Rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
Ronak.latifnezhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Arsalan Damirchi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Qazvin-Rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
damirchi@guilan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Ronak latifnezhad
Position
Msc student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Qazvin-Rasht road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
Ronak.latifnezhad@yahoo.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