Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402674777836 Date of Approval: 15/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Caffeine Ingestion on Endurance Performance, Psychological state, and Oxidative Stress Status in Young Recreational Runners
Official scientific title Low-dose Caffeine Ingestion Improves Exhaustive Endurance Performance and does not Affect Oxidative Stress Markers in Young Recreational Runners
Brief summary describing the background and objectives of the trial Background: Caffeine has been widely used in endurance sports owing to its performance-enhancing impact. However, its main effect on oxidative stress induced by such efforts is still unclear. Purpose This study aimed to examine the effects of low-dose caffeine ingestion on performance and oxidative stress markers (i.e., glutathione peroxidase (GPX), reduced glutathione (GSH), superoxide dismutase (SOD), and malondialdehyde (MDA)) after an exhaustive endurance exercise in 13 recreational runners being physical education students.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 30/01/2024
Actual trial start date 30/01/2024
Anticipated date of last follow up 20/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 13
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo caplsule containing succrose 30 min subjects ingested a capsule containing a placebo. An hour later, they performed an exhaustive run around a 400m outdoor athletic track. Blood intake was carried out before and after exercise. 13 Placebo
Experimental Group caffeine 3 mg/kg of body mass of caffeine 30 min subjects ingested a capsule containing 3 mg/kg of body mass of caffeine. An hour later, they performed an exhaustive run around a 400m outdoor athletic track. Blood intake was carried out before and after exercise. 13
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
health males physicak education students light caffeine users high caffeine users sedentary subjects Adult: 19 Year-44 Year 16 Year(s) 22 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/01/2024 the Sfax University ethics committee
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA, 3029 Sfax, Tunisie - 3029 Sfax sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Our study suppose that 3 mg/kg of body mass caffeine intake enhanced oxidative stress markers after run
Primary Outcome Our study suppose that 3 mg/kg of body mass caffeine intake enhanced the oxidative stress state after an exhaustive endurance exercise. after running
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
high institute of sports and physical education of Sfax Tunisia road elmatar Sfax 3064 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
university Avenue Majida BOULILA, 3029 Sfax, Tunisie - 3029 Sfax sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none none none none Tunisia none
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amir khcharem amir.khcharem@isseps.usf.tn +21694551111 road sokra km4 raoutha city Sfax
City Postal code Country Position/Affiliation
Sfax 3064 Tunisia university teacher
Role Name Email Phone Street address
Public Enquiries liwa masmoudi liwa.masmoudi@isseps.usf.tn +21696552822 road saltniya city raoutha 3064 sfax
City Postal code Country Position/Affiliation
sfax 3064 Tunisia university teacher
Role Name Email Phone Street address
Scientific Enquiries zouheir sahnoun zouheir.sahnoun.fms@gmail.com +21698545225 sokra road km 3 3064 sfax
City Postal code Country Position/Affiliation
sfax 3064 Tunisia university teacher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available (including data dictionaries) Study Protocol Beginning 9 months and ending 36 months following article publication. Data are available "open" indefinitely at (Link will be included).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information