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.: PACTR202402524926856 Date of Approval: 05/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Performance and biochemical responses in young athletes: Effects of melatonin and caffeine ingestion
Official scientific title Performance and biochemical responses in young athletes: Effects of melatonin and caffeine ingestion .
Brief summary describing the background and objectives of the trial Antioxidant supplementation has recently been recognised by sports populations as a method of reducing muscle damage during exercise. In this respect, melatonin and caffeine are not only chemical substances with strong antioxidant properties, but they also have a number of ergogenic effects which improve sporting performance. Therefore, This study investigated the acute effect of caffeine (CAF) and melatonin (MEL) on the biochemical and physiological responses and physical and psycho-cognitive performance of young athletes. In a randomised, double-blind, cross-over design, athletes attended four experimental sessions where they consumed a capsule containing either 6 mg melatonin (MEL) or placebo melatonin (PLA MEL) 30 min before going to sleep and the following morning they consumed capsules containing either 6 mg∙kg-1 caffeine (CAF) or placebo caffeine (PLA CAF). In order to study biochemical markers of muscle damage and inflammation, physiological, psychological and physical responses, the athletes performed the 5m shuttle test (5mSRT) 60 min after ingesting CAF or PLA CAF
Type of trial RCT
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 01/05/2023
Actual trial start date 08/05/2023
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date 30/06/2023
Anticipated target sample size (number of participants) 16
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 a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CAF supplementation 3 mg/kg 1 every two weeks In the morning, athletes ingested CAF with 200 ml, of water, 60 min before performing the 5mSRT 12
Experimental Group MEL supplementation 6 mg 1 every two weeks 30 min before going to bed in a quiet darkened room, athletes consume 6 mg (2 capsules of 3 mg) of MEL 12
Experimental Group CAF and MEL supplementation 3 mg/kg of CAF 6 mg of MEL 1 every two weeks athletes participated in four experimental sessions, they consumed a capsule containing either 6 mg melatonin (MEL) or placebo melatonin (PLA MEL) 30 min before going to sleep and the following morning they consumed capsules containing either 3 mg∙kg-1 caffeine (CAF) or placebo caffeine (PLA CAF). 12
Control Group Placebo 1 every two weeks athletes attended four experimental sessions where they consumed a capsule containing either 6 mg melatonin (MEL) or placebo melatonin (PLA MEL) 30 min before going to sleep and the following morning they consumed capsules containing either 3 mg∙kg-1 caffeine (CAF) or placebo caffeine (PLA CAF). In order to study biochemical markers of muscle damage and inflammation, physiological, psychological and physical responses, the athletes performed the 5m shuttle test (5mSRT) 60 min after ingesting CAF or PLA CAF. 12 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants had to be: - physically active (4 ± 2 h of training/week). - non-smokers and not regular users of caffeine. - healthy (they do not have kidney, cardiovascular or liver disease) All participants do not : - use food supplements or anti-inflammatory drugs, - take psychotropic drugs or melatonin in the 3 months prior to the study - made trans-meridian journeys in the month prior to the experiment. the oposite of inclusion criteria Adult: 19 Year-44 Year 18 Year(s) 25 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 17/05/2022 the committee for the protection of Southren persons
Ethics Committee Address
Street address City Postal code Country
Menzel Chaker City Erriadh Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome biochemical responses (CK, LDH, ASAT, ALAT, CRP) before and 5 min after the 5mSRT
Primary Outcome physical performance of the 5mSRT 60 min after the CAF or PLA intake
Primary Outcome the circadian variation of the sleep/wake cycle the night before and the two following nights after each experimental test, participants wore a GT3X activity monitors on the non-dominant arm
Secondary Outcome Heart rate (HR) throughout the 5mSRT
Secondary Outcome The rate of perceived exertion (RPE) immediately after each repetition of the 5mSRT
Secondary Outcome Perceived recovery (RPS) before, after 5 min, 24h and 48h of the 5mSRT
Secondary Outcome delayed onset muscle soreness (DOMS) before, after 5 min, 24h and 48h of the 5mSRT
Secondary Outcome Hooper Index after an average of 9 hours sleep
Secondary Outcome Epworth Sleepness Scale (ESS) after an average of 9 hours sleep
Secondary Outcome visual analogic scale (vas) after an average of 9 hours sleep
Secondary Outcome Subjective Vitality Scale (SVS) 1 hour after CAF or PLA intake
Secondary Outcome Feeling scale 1 hour after CAF or PLA intake
Secondary Outcome The Brunel Mood Scale (BRUMS) 1 hour after CAF or PLA intake
Secondary Outcome Digit cancellation test 1 hour after CAF or PLA intake
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High Institute of Sport and Physical Education of Kef University of Jendouba, Boulifa University Campus Kef 7100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
savings 398 Ibn kholdoun city Kef 7117 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kef regional Hospital Kef-Tunisia kef Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Hamdi Chtourou road of the airport Sfax 3000 Tunisia
Ibrahim Ouergui kef Kef Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nourhene Mahdi nourhene648@gmail.com +21696913385 398 ibn kholdoun
City Postal code Country Position/Affiliation
Kef 7117 Tunisia High Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Scientific Enquiries Hamdi Chtourou h_chtourou@yahoo.fr +21622872095 road of the airport
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia High Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Public Enquiries Ibrahim Ouergui ouergui.brahim@yahoo.fr +21697481212 Kef
City Postal code Country Position/Affiliation
Kef 7100 Tunisia High Institute of Sport and Physical Education of Kef
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all individual participant data collected throughout the study was deidentified. there is not time limitfor ssharing the data, and it will be made available to anyone who requestes it. Informed Consent Form the end of experimentation for every participant a kef
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