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.: PACTR202306626845292 Date of Approval: 22/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Chronic Beetroot Juice Supplementation Attenuates Neuromuscular Fatigue Etiology During Simulated Soccer Match Play
Official scientific title Chronic Beetroot Juice Supplementation Attenuates Neuromuscular Fatigue Etiology During Simulated Soccer Match Play.
Brief summary describing the background and objectives of the trial In the last decade, several nutritional strategies have been proposed to protect against muscle damage, enhance performance, and attenuate neuromuscular fatigue. Among these strategies, dietary nitrate supplementation via beetroot juice (BEET) has become progressively popular, and a commonly used strategy by athletes. It is well established that dietary nitrate supplementation, such as BEET, could enhance performance. In fact, BEET supplementation increases nitric oxide (NO) bioavailability, which may induce vasodilatation, improve mitochondrial efficiency and increase muscle blood flow. Previous studies investigating the effect of BEET in team sport players’ performance indicated that BEET supplementation improves performance in trained soccer players and recreational adults. Bear in mind though that performance was assessed during the Yo-Yo test in the aforementioned studies, an activity that does not simulate the soccer match nature and duration. Likewise, the effect of BEET on neuromuscular performance is equivocal and presents controversial results
Type of trial CCT
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 Treatment: Other
Anticipated trial start date 01/02/2023
Actual trial start date 01/03/2023
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date 15/05/2023
Anticipated target sample size (number of participants) 13
Actual target sample size (number of participants) 13
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Beetroot juice supplementation for 7 days Players received Beetroot juice (2*150ml; ~ 8mmol/l nitrate) 7 days Participants were provided with BEET or PLA supplementation and instructed to consume 150 ml per serving of the supplement twice per day (08:00 and 18:00 hours) for 7 consecutive days (2* 150 ml/day for 6 days before the experimental session and 150 ml 2h before LIST on the day trial). The BEET juice was prepared from a natural beetroot fruit and was purchased from the same producer and was delivered the same day of the supplementation to participants by the researcher in charge. No extra chemical products were added to the natural beetroot juice. Each bottle contained 250mg of nitrate equivalent to ~4mmol/l. Previous studies have shown that this amount was able to induce a significant increase in plasma nitrate and nitrite concentrations. The PLA consisted of a commercial fruit squash, mixed with maltodextrin, flavorless protein powder, and water to match the BEET drink as closely as possible for volume and nutrient content 13
Control Group placebo supplementation ~0mmol/l per day nitrate 7 days Players received either BEET (2*150ml; ~ 8mmol/l nitrate) or PLA for 7 days (6 days prior to the experimental session and on the day trial, 2h before LIST) 13 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
male soccer players playing for the last 2 years for a semi-professional local club training 4 times per week muscle-skeletal injury Allergies from nitrate Adult: 19 Year-44 Year 20 Year(s) 35 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 14/04/2023 personal protection committee
Ethics Committee Address
Street address City Postal code Country
Street Majida BOULILA, 3029 Sfax, Tunisie Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maximal voluntary contraction (MVC) and twitch responses, delivered through electrical femoral nerve stimulation, were used to assess peripheral (quadriceps resting twitch force, Qtw, pot) and central fatigue (voluntary activation, VA) before match, 45minutes and at the end of the exercise
Secondary Outcome Ratings of perceived exertion (RPE), Heart rate (HR) Before the exercise, 45minutes and at the end of the exercise
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Higher Institute of Sport and Physical Education of Sfax Airport street- Sfax - 3000 Tunisie Sfax 2100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
NA Street airport- Sfax Sfax Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wael Daab Airport Street Sfax Sfax Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
Mohamed Amine Bouzid Street lhabib Sfax Sfax Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohamed Amine Bouzid mohamedamine.bouzid@isseps.usf.tn +21622062275 Street Lahbib Sfax
City Postal code Country Position/Affiliation
Sfax Tunisia Assistant professor
Role Name Email Phone Street address
Principal Investigator Wael Daab daab_w@yahoo.fr +21620612799 Street al guitna
City Postal code Country Position/Affiliation
Sfax Tunisia PHD
Role Name Email Phone Street address
Public Enquiries Mohamed Amine Bouzid mohamedamine.bouzid@isseps.usf.tn +21622062275 Street Alhabib Sfax
City Postal code Country Position/Affiliation
Sfax Tunisia Assistant professor Issep Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all collected IPD, all IPD that underlie results in a publication Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following the review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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