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.: PACTR202402599578303 Date of Approval: 12/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Crocus Sativus Linnaeus (Saffron) intake on physiological and perceptual responses during a repeated sprint test in healthy active young males
Official scientific title Effect of Crocus Sativus Linnaeus (Saffron) intake on physiological and perceptual responses during a repeated sprint test in healthy active young males
Brief summary describing the background and objectives of the trial Saffron (SAF) ingestion is considered as ergogenic aids to enhance performance, however, the ergogenic effects of SAF ingestion are unclear during repeated-sprint ability test (RSS). This study aimed to investigate the effects of acute ingestion of saffron (SAF) on physiological (heart rate (HR) and blood lactate [BL]) and perceptual (ratings of perceived exertion [RPE] and feeling scale [FS]) measures in response to a RSS in healthy active young males. Twenty-two male sports students (mean ± SD: age, 21.7±1.24 yrs.) completed two experimental trials using a randomized, double-blind study design. In each session, the participants were randomly chosen to receive either a capsule of saffron (300 mg) (SAF session) or a capsule of lactose (PLB session) two hours before performing the RSS. The assessed parameters comprised RSS performance indices (peak time, total time, and fatigue index), HR, BL, RPE and FS. Peak time, total time, fatigue index and BL did not change significantly (p>0.05) in the SAF or PLB sessions. No significant differences were observed between the SAF or PLB sessions for HR, RPE and FS in pre- and post-RSS. Acute SAF ingestion did not significantly improve active young males' RSS performance or physiological and perceptual measures. Future trials should address the topic using higher dose-/acute and -/prolonged intake of SAF on biological, physical, physiological, and perceptual responses to acute and chronic exercise.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Healthy active young males
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 24/04/2023
Actual trial start date 24/04/2023
Anticipated date of last follow up 03/05/2023
Actual Last follow-up date 03/05/2023
Anticipated target sample size (number of participants) 25
Actual target sample size (number of participants) 22
Recruitment status Active, not recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Saffron supplementation Each participant received either a capsule filled with 300 mg saffron powder (SAF session) or a visually identical capsule filled with 300 mg lactose powder (PLB session). Two hours after ingesting the capsule, each participant performed the repeated-sprint sets test (RSS) to measure peak time (PT), total time (TT) and fatigue index (FI). Heart rate (HR) was measured before and during the RSS, and blood lactate concentration was measured immediately after this test. Before (Pre) and after (Post) the test, ratings of perceived exertion (RPE) and feeling scale (FS) were also measured. All supplements were blinded and randomized by a separate researcher not involved in the data collection to ensure the double-blind study design. 10 days In this double-blind, randomized trial, participants performed two experimental sessions with a one-week washout period. Each participant received either a capsule filled with 300 mg saffron powder (SAF session) or a visually identical capsule filled with 300 mg lactose powder (PLB session). Two hours after ingesting the capsule, each participant performed the repeated-sprint sets test (RSS) to measure peak time (PT), total time (TT) and fatigue index (FI). Heart rate (HR) was measured before and during the RSS, and blood lactate concentration was measured immediately after this test. Before (Pre) and after (Post) the test, ratings of perceived exertion (RPE) and feeling scale (FS) were also measured. All supplements were blinded and randomized by a separate researcher not involved in the data collection to ensure the double-blind study design. Research Randomizer (https://www.randomlists.com/team-generator), was used to randomly assign subjects to each experimental condition. All subjects were prohibited from consuming any dietary supplements and were instructed to refrain from vigorous physical exercise for at least 24 h before each test session. In addition, all subjects were instructed to consume their habitual dietary. To avoid circadian variation, the two sessions were conducted at the same time of day for each participant (± 1 hour). 22
Control Group Placebo supplementation Each participant received either a capsule filled with 300 mg saffron powder (SAF session) or a visually identical capsule filled with 300 mg lactose powder (PLB session). Two hours after ingesting the capsule, each participant performed the repeated-sprint sets test (RSS) to measure peak time (PT), total time (TT) and fatigue index (FI). Heart rate (HR) was measured before and during the RSS, and blood lactate concentration was measured immediately after this test. Before (Pre) and after (Post) the test, ratings of perceived exertion (RPE) and feeling scale (FS) were also measured. All supplements were blinded and randomized by a separate researcher not involved in the data collection to ensure the double-blind study design. 10 days In this double-blind, randomized trial, participants performed two experimental sessions with a one-week washout period. Each participant received either a capsule filled with 300 mg saffron powder (SAF session) or a visually identical capsule filled with 300 mg lactose powder (PLB session). Two hours after ingesting the capsule, each participant performed the repeated-sprint sets test (RSS) to measure peak time (PT), total time (TT) and fatigue index (FI). Heart rate (HR) was measured before and during the RSS, and blood lactate concentration was measured immediately after this test. Before (Pre) and after (Post) the test, ratings of perceived exertion (RPE) and feeling scale (FS) were also measured. All supplements were blinded and randomized by a separate researcher not involved in the data collection to ensure the double-blind study design. Research Randomizer (https://www.randomlists.com/team-generator), was used to randomly assign subjects to each experimental condition. All subjects were prohibited from consuming any dietary supplements and were instructed to refrain from vigorous physical exercise for at least 24 h before each test session. In addition, all subjects were instructed to consume their habitual dietary. To avoid circadian variation, the two sessions were conducted at the same time of day for each participant (± 1 hour). 22 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- No history of chronic disease. - No smoking. - No history of dietary supplements intake or drug consumption within six months before enrolment into the study. - Based on the evaluation of the medical doctor, all participants were diagnosed as free from lower limbs musculoskeletal. - Neuromuscular disorders and musculoskeletal injuries that would affect test performance. - Participation in another experimental protocol within the past 6 months. - Non-compliance to the experimental protocol, and incomplete data. Adult: 19 Year-44 Year 20 Year(s) 24 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 04/04/2023 Ethic committee of Research Unit Sport Sciences Health and Movement of High Institute of Sport and Physical Education of Kef
Ethics Committee Address
Street address City Postal code Country
University of Jendouba Higher Instituteof Sport and Physical Education of Kef Boulifa University Campus Kef Tunisia. Kef 7100 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome No significant change was observed in repeated-sprint ability test (RSS) performance indices (peak time, total time and fatigue index) after acute saffon (SAF) (300 mg) or placebo supplementation. Immediately after execution of RSS
Secondary Outcome No significant differences were observed between the saffon (SAF) or placebo (PLB) sessions for heart rate, ratings of perceived exertion and feeling scale in pre- and post- repeated-sprint ability test (RSS). Before and after execution of RSS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High Institute of Sports and Physical Education of Kef Boulifa University Campus 7100 Kef Tunisia Kef 7100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Unit Sport Sciences Health andMovement of High Institute of Sport and PhysicalEducation of Kef Boulifa University Campus 7100 Kef Tunisia Kef 7100 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No No NO 0000 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
Nejmeddne Ouerghi Dahmani Dahmani 7170 Tunisia
Wissal Abassi Dahmani Dahmani 7170 Tunisia
Nidhal Jebabli City Jebabli Tajerouine 7150 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nejmeddine Ouerghi najm_ouerghi@hotmail.com 002162530022 Dahmani
City Postal code Country Position/Affiliation
Dahmani 7170 Tunisia PhD researcher in High Institute of Sportand Physical Education of Kef
Role Name Email Phone Street address
Public Enquiries Wissal Abassi wissalabassi93@gmail.com 0021693304684 Kalaat Senan
City Postal code Country Position/Affiliation
Kalaat Senan 7130 Tunisia PhD researcher in High Institute of Sportand Physical Education of Kef
Role Name Email Phone Street address
Scientific Enquiries Nidhal Jebabli jnidhal@gmail.com 00216253160 City Jebabli
City Postal code Country Position/Affiliation
Tajerouine 7150 Tunisia PhD researcher in High Institute of Sportand Physical Education of Kef
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As part of our commitment to transparency and scientific collaboration, we plan to share the individual trial participant data in an anonymized manner. In accordance with the World Health Organization's(WHO) data sharing policy, thisIPD sharing statement aims to promote the replicability ofstudy results and facilitatefurther analysis by the scientific community. The individual trial participant data collected forthis study includes demographic information,medical history, treatment interventions, and clinicaloutcomes. All personally identifiable information has been rigorously removed or anonymized to protect the confidentiality of the participants. Only anonymous identification codes are used to link the data to individual participants. Statistical Analysis Plan,Study Protocol The IPD of this study areavailable from any demands The IPD of this study are available from any demands
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 11/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information