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.: PACTR202208691866055 Date of Approval: 19/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Branched-Chain Amino Acids Supplementation on Physical and Cognitive Performance and Biological Responses
Official scientific title Effect of Branched-Chain Amino Acids Supplementation on Physical and Cognitive Performance and Biological Responses
Brief summary describing the background and objectives of the trial Amino acids, or their derivatives, are among a multitude of nutritional supplements that are highly popular with athletes since they are considered to have ergogenic benefits. Almost all athletes assume that amino acids might help them improve their performance (Goron & Moinard, 2018). Amino acids are not always found in food. Consequently, athletes are going with dietary supplements. Amino acids, often known as protein building blocks, are chemicals that perform a variety of important processes in your body. Out of the 20 amino acids, 9 are classified as essential amino acids (EAAs), meaning they can’t be produced in the body and must be obtained from food (Morse & Willoughby, 2019). A group of three amino acids, including leucine, isoleucine, and valine (LIV), are recognized as branched-chain amino acids (BCAA). Likewise, BCAAs account for almost 50% of EAAs in food and 35% of the total content of EAAs in muscle proteins (Harper et al., 1984; Rennie & Tipton, 2000). Moreover, the BCAA components are catabolized first in the skeletal muscles; in contrast, other amino acids are catabolized in the liver (Harper et al., 1984). The effects of BCAA on muscle tissue regeneration and restoration as a nutrition therapy have particularly gained attention in recent years. BCAA supplementation has been proposed as an alternative dietary strategy for optimizing physical performance while also reducing fatigue and accelerating the post-exercise recovery process. The effects of BCAA supplementation on physical performance and post-exercise recovery varied from study to study, considering that the exercise protocols, supplementation strategy, and the explanations of this currently are unclear (Peel et al., 2021). Thus, we aim to investigate the effects of BCAA supplementation with different strategies on physical performance, cognitive functions, and recovery kinetics post-exercise.
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 02/01/2023
Actual trial start date
Anticipated date of last follow up 08/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0409 Committee for the Protection of Southern Persons
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 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo control 10 g per day of Erythritol 5 days Participants will ingest only 10 g.day-1 of erythritol (5 g twice) during days 1, 2, 4 and 5. On day 3, participants will ingest 5 g of erythritol before and immediately after the 5mSRT, and 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10 Placebo
Experimental Group Low dose of BCAA 10 g per day of 2:1:1 BCAA 5 days Participants will ingest only 10 g.day-1 of BCAA (5 g twice) during days 1, 2, 4 and 5. On day 3, participants will ingest 5 g of BCAA before and immediately after the 5mSRT, and again 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10
Experimental Group High dose of BCAA 20 g per day of 2:1:1 BCAA 5 days Participants will ingest only 20 g.day-1 of BCAA (10 g twice) during days 1, 2, 4 and 5. On day 3, participants will ingest 10 g of BCAA before and immediately after the 5mSRT, and again 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10
Experimental Group Pre Test BCAA Supplementation 10 g per day of 2:1:1 BCAA or 10 g per day of Erythritol 5 days Participants will ingest 10 g.day-1 of BCAA (5 g twice) during days 1 and 2 and 10 g.day-1 of erythritol (5 g twice). 4 and 5. On day 3, participants will ingest 5 g of BCAA before and immediately after the 5mSRT, and again 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10
Experimental Group Post Test BCAA Supplementation 10 g per day of Erythritol or 10 g per day of 2:1:1 BCAA 5 days Participants will ingest 10 g.day-1 of erythritol (5 g twice) during days 1 and 2 and 10 g.day-1 of BCAA (5 g twice) on days 4 and 5. On day 3, participants will ingest 5 g of erythritol and 5 g of BCAA immediately after the 5mSRT and again 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10
Experimental Group Leucine Enriched BCAA 1 10 g per day of 8:1:1 BCAA 5 days Participants will ingest only 10 g.day-1 of leucine-enriched BCAA with an 8:1:1 ratio (5 g twice) during days 1, 2, 4, and 5. On day 3, participants will ingest 5 g of leucine enriched BCAA with an 8:1:1 ratio before and immediately after the 5mSRT, and again 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10
Experimental Group Leucine Enriched BCAA 2 10 g per day of 15:1:1 BCAA 5 days Participants will ingest only 10 g.day-1 of leucine-enriched BCAA with a 15:1:1 ratio (5 g twice) during days 1, 2, 4, and 5. On day 3, participants will ingest 5 g of leucine enriched BCAA with a 15:1:1 ratio before and immediately after the 5mSRT, and again 2 days after the 5mSRT. Then each participant will be assessed to perform physical tests and blood sample collection 5 min before and 5 min after the 5mSRT. A 24 h and 48 h follow-up will be used to assess the recovery kinetics of biochemical parameters and physical tests. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants trained at least 4 sessions per week with at least 3 years of training history. aged at least 19 years old. Injury-free. exhibited dysfunctional symptoms of the musculoskeletal or cardio-pulmonary system. Consuming creatine within the past six months and taking any antioxidant (e.g., vitamin E, A, C, etc.), anti-inflammatory, caffeine, or alcohol during the experimentation period and one month before participating in any high-intensity sessions before 72 h and during the experimentation period. Adult: 19 Year-44 Year 19 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 Committee for the Protection of Southern Persons
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA, 3029 Sfax, Tunisie Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical performance during the 5mSRT:assessed using GPS tracking system heart rate sensors during exercise to record covored distance and peak and mean HR. During the 5mSRT
Primary Outcome Biochemical parameter: • muscle damage markers (creatine kinase (CK), Aspartate transaminase (AST) and Lactate dehydrogenase (LDH)) • plasma concentrations of amino acids (Branched-chain amino acids (BCAA), Leucine (Leu), isoleucine (Ile), and valine (Val)) 5 min before, 5 min, 24 h, and 48 h after the 5mSRT
Primary Outcome Physical parameters: jump tests 5 min before, 5 min, 24 h, and 48 h after the 5mSRT
Primary Outcome Delayed onset of muscle soreness 5 min before, 5 min, 24 h, and 48 h after the 5mSRT
Secondary Outcome Psychological questionnaires: Mood state and the hooper’s index Before, 24 h, and 48 h after the 5mSRT
Primary Outcome Cognitive functions (Digit cancelation test (DCT) and reaction time (RT)) 5 min before, 5min, 24 h, and 48 h after the 5mSRT
Secondary Outcome Sleep quality Once per week, in day 5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
High institut of sports and physical activity of Sfax Airport Road, Km 3,5, BP 384 Sfax 3000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Atef Salem Sened Gafsa 2190 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratory of Biochemistry CHU Habib Bourguiba CHU Habib Bourguiba, Sfax University, Sfax Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Hamdi Chtourou Road Airport Sfax 3000 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef SALEM Salematef120@gmail.com +21623874933 Sened
City Postal code Country Position/Affiliation
Gafsa 2190 Tunisia Physical Activity Sport and Health UR18JS01 National Observatory of Sport Tunis 1003 Tunisia.
Role Name Email Phone Street address
Scientific Enquiries Hamdi CHTOUROU H_chtourou@yahoo.fr +21622872095 Road Airport
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Physical activity Sport and health UR18JS01 Observatoire National du Sport Tunis Tunisia
Role Name Email Phone Street address
Public Enquiries Sami HIDOURI samihidouri4@gmail.com +21627974272 Omrane city - Manzel bouzaienne
City Postal code Country Position/Affiliation
Sidi Bouzid 9114 Tunisia Research Laboratory Education Motricity Sport and health LR19JS01 High Institute of Sport and Physical Education of Sfax Tunisia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the individual participant data collected during the trial, after de-identification Informed Consent Form The end of experimentation For every participant, a key
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