Protocol summary

Study aim
Study of exercise performance and responses of coagulation, fibrinolysis, hormonal and metabolic systems to caffeine consumption in the morning and evening
Design
Randomized, double-blind, crossover, placebo-controlled trial design, phase 3 on 120 subjects. The rand function of Excel was used for randomization.
Settings and conduct
Each participant will participate in 4 experiment sessions with 7 days intervals: 2 sessions in the morning and 2 sessions in the evening following the ingestion of caffeine or a placebo. Each session will include: HIE (4 sets of 100-meter sprints), resistance exercise (2 sets of 12 repetitions at 70% of1RM for chest press, lat pulldown, shoulder press, and leg press), 30 min of aerobic exercise (running on a treadmill at 70% of maximal oxygen consumption), and a Wingate anaerobic test at the end of the session. Blood samples will be collected before, immediately after, and 30 minutes after the completion of each session. This study will be conducted in a double-blind manner, meaning that the administration of the supplement or placebo will be carried out by an individual not involved in the study, and the researchers will remain unaware of the assignments until after statistical analysis is completed. All study procedures will be conducted in Turkey.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Don't smoke؛ Do not consume alcohol؛ Have not taken any sports supplements in the past 6 months؛ Do not have a habit of consuming caffeine؛ Do not suffer from cardiovascular and hematological diseases.
Intervention groups
Acute supplementation of caffeine (3 mg/kg) or placebo (200 mg cellulose) + one exercise session + in the morning (8-10) and evening (17-19) for all participants according to the crossover study design.
Main outcome variables
Von Willebrand factor; VIII factor; Fibrinogen; Platelate; PAI-1 activity; tPA antigen; tPA activity; Testosterone; Cortisol; Anaerobic power.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231004059615N2
Registration date: 2025-03-15, 1403/12/25
Registration timing: prospective

Last update: 2025-03-15, 1403/12/25
Update count: 0
Registration date
2025-03-15, 1403/12/25
Registrant information
Name
Davar Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 3583
Email address
davar.khodadadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-25, 1404/01/05
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acute caffeine intake on exercise performance, hemostasis, and metabolism at different times of day
Public title
The effect of circadian rhythm on exercise performance and homeostatic and metabolic responses to acute caffeine intake.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Don't smoke. Do not consume alcohol. Have not taken any sports supplements in the past 6 months. Do not have a habit of consuming caffeine. Do not suffer from cardiovascular and hematological diseases. Healthy subjects should have a body mass index of 18.5 - 24.9. Obese subjects should have a body mass index ≥ 30. Trained subjects should have a regular exercise history in the past 3 years. Untrained subjects should not have a history of regular exercise in the past 6 months.
Exclusion criteria:
Having caffeine habituation Cardiovascular and hematological diseases Having a physical injury that prevents from exercising. Having a body mass index of less than 18.5 and more than 24.9 for healthy subjects and less than 30 for obese subjects
Age
From 20 years old to 30 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method and using Excel's Random function, all subjects will be assigned to caffeine and placebo conditions.
Blinding (investigator's opinion)
Double blinded
Blinding description
The caffeine or placebo capsules will be prepared by someone other than the research team. The researchers and statistical analysts will not be informed of the nature of the data related to the groups until after the statistical analysis is complete.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the International Science and Technology University
Street address
Tunahan Mah. Dumlupinar 30 Agustos Cad. No:2, Metromal Business F Blok Office
City
Ankara
Postal code
21,06824
Approval date
2025-03-03, 1403/12/13
Ethics committee reference number
202503-01

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

2

Description of health condition studied
cardiovascular disorders
ICD-10 code
Z13.6
ICD-10 code description
Encounter for screening for cardiovascular disorders

Primary outcomes

1

Description
von Willebrand factor level
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

2

Description
VIII factor level
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

3

Description
Fibrinogen level
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
Coagulometer

4

Description
Platelet count
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
Blood cell counter

5

Description
Inhibitor of plasminogen activator type 1 (PAI-1) activity
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

6

Description
Tissue plasminogen activator (tPA) antigen level
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

7

Description
tPA activity
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

8

Description
Testosterone level
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

9

Description
Cortisol level
Timepoint
Before, immediately after, and 30 minutes after each exercise session
Method of measurement
ELISA

10

Description
Anaerobic power
Timepoint
At the end of each exercise session
Method of measurement
Wingate test

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Obesity; According to the crossover design, each subject will participate in 4 experimental sessions: 2 sessions in the morning and 2 sessions in the evening following caffeine (3 mg/kg) or placebo intake. Each session will include: high-intensity interval exercise (4 sets of 100-meter sprint), resistance training (2 sets of 12 repetitions at 70% of 1-rep max for chest press, pull-up bar, shoulder press, leg press), 30 minutes of aerobic exercise (treadmill running at 70% of VO2max), and a Wingate anaerobic test at the end of the session.
Category
Prevention

2

Description
Second intervention group: Healthy untrained; According to the crossover design, each subject will participate in 4 experimental sessions: 2 sessions in the morning and 2 sessions in the evening following caffeine (3 mg/kg) or placebo intake. Each session will include: high-intensity interval exercise (4 sets of 100-meter sprint), resistance training (2 sets of 12 repetitions at 70% of 1-rep max for chest press, pull-up bar, shoulder press, leg press), 30 minutes of aerobic exercise (treadmill running at 70% of VO2max), and a Wingate anaerobic test at the end of the session.
Category
Prevention

3

Description
Third intervention group: Healthy trained; According to the crossover design, each subject will participate in 4 experimental sessions: 2 sessions in the morning and 2 sessions in the evening following caffeine (3 mg/kg) or placebo intake. Each session will include: high-intensity interval exercise (4 sets of 100-meter sprint), resistance training (2 sets of 12 repetitions at 70% of 1-rep max for chest press, pull-up bar, shoulder press, leg press), 30 minutes of aerobic exercise (treadmill running at 70% of VO2max), and a Wingate anaerobic test at the end of the session.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Full name of responsible person
Heidar Sajedi
Street address
Tunahan Mah. Dumlupinar 30 Agustos Cad. No:2, Metromal Business F Blok Office
City
Ankara
Postal code
21,06824
Phone
+90 312 475 76 15
Email
heidar.sajedi@istu.edu.pl

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Full name of responsible person
Erdal Dursun
Street address
Tunahan Mah., Dumlupinar 30 Agustos Cad. No. 2, Metromal Business F Blok Office
City
Ankara
Postal code
21,06824
Phone
+90 312 475 76 15
Email
heidar.sajedi@istu.edu.pl
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
TR
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davar Khodadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2263 3583
Fax
Email
davar.khodadadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davar Khodadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2263 3583
Fax
Email
davar.khodadadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davar Khodadadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
City
Tehran
Province
Tehran
Postal code
1955847781
Phone
+98 21 2263 3583
Fax
Email
davar.khodadadi@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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be published after the extracted articles are accepted.
When the data will become available and for how long
after the extracted articles are accepted
To whom data/document is available
All people
Under which criteria data/document could be used
The data will be published after the extracted articles are accepted.
From where data/document is obtainable
If there are valid reasons to access the data, the applicants can receive the required data by sending an email to the person responsible for scientific inquiries or the corresponding author of the article. (davar.khodadadi@yahoo.com)
What processes are involved for a request to access data/document
If the data is not published with the extracted articles, an email will need to be sent to the corresponding author. (davar.khodadadi@yahoo.com)
Comments
Loading...