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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05143879
Other study ID # ULE-020-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date October 1, 2021

Study information

Verified date November 2021
Source Burgos Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Citrulline (CIT) and nitrate-rich beetroot extract (BEET) are widely studied ergogenic aids. However, both supplements have been studied in sort-term and isolated. To the best of the authors' knowledge, the effects of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have not been investigated to date. Therefore, the main purpose of this study was to determine the effect and degree of potentiation of the long-term (9 weeks) mixture of 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT) supplementation on EIMD markers (urea, creatinine, AST, ALT, GGT, LDH and CK) and anabolic/catabolic hormone status (testosterone, cortisol and Testosterone cortisol ratio (T/C)) in male trained triathletes. This study was a double-blind, placebo-controlled trial where participants (n = 32) were randomized into 4 different groups: placebo group (PLG; n = 8), CIT group (CITG; 3 g/day of CIT; n = 8), BEET group (BEETG; 2.1 g/day of BEET (300 mg/day of NIT) ; n = 8) and CIT-NIT group (CIT-BEETG; 3 g/day of CIT plus 2.1 g/day of BEET (300 mg/day of NIT); n = 8). Blood samples were collected from all participants at baseline (T1) and after 9 weeks of supplementation (T2).


Description:

Triathlon is an endurance sport in which athletes compete sequentially in swimming, cycling and running. Prolonged and strenuous training combined with insufficient recovery can produce muscular and metabolic stress, resulting in structural and functional damage to the musculoskeletal system leading to a fatigue status, which results in decreased athletic performance. As a consequence of this type of combined exercise, there are also alterations in biochemical markers of exercise-induced muscle damage (EIMD) as well as anabolic/catabolic hormones. Therefore, their analysis is useful in determining the balance between training loads and recovery. In this sense, it is essential to include different strategies to reduce or prevent EIMD, which delay or reduce muscle fatigue and improve sports performance. One of these strategies is the use of different ergogenic aids such as L-citrulline (CIT) and nitrates (NIT) which have been proposed as both substances produce an increase in nitric oxide (NO).


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 1, 2021
Est. primary completion date August 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 35 Years
Eligibility Inclusion Criteria: - Males between 25 and 35 years old - Triathletes - With at least 5 years of experience - Without any disease - Non smokers - Non drinkers of alcohol - Not to take any other medications or stimulant substances during the study - 2 weeks without taking other nutritional supplements Exclusion Criteria: - Exclusion criteria: - Men under 25 and over 35 years of age. - Non triathletes - Less than 5 years of experience - With any disease - Smokers - Alcohol drinkers

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Citrulline
3 g/day during 9 weeks
Nitrate
300 mg/day during 9 weeks
Nitrate plus Citrulline
3 g/day of citrulline and 300 mg/day of nitrate during 9 weeks
Placebo
3 g/day during 9 weeks

Locations

Country Name City State
Spain University of Leon León Castilla Y León

Sponsors (4)

Lead Sponsor Collaborator
Burgos Nutrition Universidad de León, University of the Basque Country (UPV/EHU), University of Valladolid

Country where clinical trial is conducted

Spain, 

References & Publications (20)

Anderson JE. A role for nitric oxide in muscle repair: nitric oxide-mediated activation of muscle satellite cells. Mol Biol Cell. 2000 May;11(5):1859-74. — View Citation

Bailey SJ, Blackwell JR, Lord T, Vanhatalo A, Winyard PG, Jones AM. l-Citrulline supplementation improves O2 uptake kinetics and high-intensity exercise performance in humans. J Appl Physiol (1985). 2015 Aug 15;119(4):385-95. doi: 10.1152/japplphysiol.001 — View Citation

Clifford T, Bell O, West DJ, Howatson G, Stevenson EJ. The effects of beetroot juice supplementation on indices of muscle damage following eccentric exercise. Eur J Appl Physiol. 2016 Feb;116(2):353-62. doi: 10.1007/s00421-015-3290-x. Epub 2015 Nov 4. — View Citation

Curis E, Nicolis I, Moinard C, Osowska S, Zerrouk N, Bénazeth S, Cynober L. Almost all about citrulline in mammals. Amino Acids. 2005 Nov;29(3):177-205. Epub 2005 Aug 8. Review. — View Citation

da Silva DK, Jacinto JL, de Andrade WB, Roveratti MC, Estoche JM, Balvedi MCW, de Oliveira DB, da Silva RA, Aguiar AF. Citrulline Malate Does Not Improve Muscle Recovery after Resistance Exercise in Untrained Young Adult Men. Nutrients. 2017 Oct 18;9(10). — View Citation

Daab W, Bouzid MA, Lajri M, Bouchiba M, Saafi MA, Rebai H. Chronic Beetroot Juice Supplementation Accelerates Recovery Kinetics following Simulated Match Play in Soccer Players. J Am Coll Nutr. 2021 Jan;40(1):61-69. doi: 10.1080/07315724.2020.1735571. Epu — View Citation

Garnacho-Castaño MV, Palau-Salvà G, Serra-Payá N, Ruiz-Hermosel M, Berbell M, Viñals X, Bataller MG, Carbonell T, Vilches-Saez S, Cobo EP, Molina-Raya L. Understanding the effects of beetroot juice intake on CrossFit performance by assessing hormonal, met — View Citation

Gilligan DM, Panza JA, Kilcoyne CM, Waclawiw MA, Casino PR, Quyyumi AA. Contribution of endothelium-derived nitric oxide to exercise-induced vasodilation. Circulation. 1994 Dec;90(6):2853-8. — View Citation

Gonzalez AM, Trexler ET. Effects of Citrulline Supplementation on Exercise Performance in Humans: A Review of the Current Literature. J Strength Cond Res. 2020 May;34(5):1480-1495. doi: 10.1519/JSC.0000000000003426. — View Citation

Jones AM, Thompson C, Wylie LJ, Vanhatalo A. Dietary Nitrate and Physical Performance. Annu Rev Nutr. 2018 Aug 21;38:303-328. doi: 10.1146/annurev-nutr-082117-051622. — View Citation

McMahon NF, Leveritt MD, Pavey TG. The Effect of Dietary Nitrate Supplementation on Endurance Exercise Performance in Healthy Adults: A Systematic Review and Meta-Analysis. Sports Med. 2017 Apr;47(4):735-756. doi: 10.1007/s40279-016-0617-7. Review. — View Citation

Milton-Laskibar I, Martínez JA, Portillo MP. Current Knowledge on Beetroot Bioactive Compounds: Role of Nitrate and Betalains in Health and Disease. Foods. 2021 Jun 7;10(6). pii: 1314. doi: 10.3390/foods10061314. Review. — View Citation

Monau TR, Vargas VE, Zhang L, Myers DA, Ducsay CA. Nitric oxide inhibits ACTH-induced cortisol production in near-term, long-term hypoxic ovine fetal adrenocortical cells. Reprod Sci. 2010 Oct;17(10):955-62. doi: 10.1177/1933719110376092. Epub 2010 Aug 16 — View Citation

Pérez-Guisado J, Jakeman PM. Citrulline malate enhances athletic anaerobic performance and relieves muscle soreness. J Strength Cond Res. 2010 May;24(5):1215-22. doi: 10.1519/JSC.0b013e3181cb28e0. — View Citation

Rammos C, Luedike P, Hendgen-Cotta U, Rassaf T. Potential of dietary nitrate in angiogenesis. World J Cardiol. 2015 Oct 26;7(10):652-7. doi: 10.4330/wjc.v7.i10.652. Review. — View Citation

Richards JC, Racine ML, Hearon CM Jr, Kunkel M, Luckasen GJ, Larson DG, Allen JD, Dinenno FA. Acute ingestion of dietary nitrate increases muscle blood flow via local vasodilation during handgrip exercise in young adults. Physiol Rep. 2018 Jan;6(2). doi: — View Citation

Viribay A, Arribalzaga S, Mielgo-Ayuso J, Castañeda-Babarro A, Seco-Calvo J, Urdampilleta A. Effects of 120 g/h of Carbohydrates Intake during a Mountain Marathon on Exercise-Induced Muscle Damage in Elite Runners. Nutrients. 2020 May 11;12(5). pii: E1367 — View Citation

Wang JM, Gu CH, Tao L, Wu XL. Effect of surgery and efferent duct ligation on testicular blood flow and testicular steroidogenesis in the rat. J Reprod Fertil. 1985 Jan;73(1):191-6. — View Citation

Wax B, Kavazis AN, Luckett W. Effects of Supplemental Citrulline-Malate Ingestion on Blood Lactate, Cardiovascular Dynamics, and Resistance Exercise Performance in Trained Males. J Diet Suppl. 2016;13(3):269-82. doi: 10.3109/19390211.2015.1008615. Epub 20 — View Citation

Wylie LJ, Park JW, Vanhatalo A, Kadach S, Black MI, Stoyanov Z, Schechter AN, Jones AM, Piknova B. Human skeletal muscle nitrate store: influence of dietary nitrate supplementation and exercise. J Physiol. 2019 Dec;597(23):5565-5576. doi: 10.1113/JP278076 — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cortisol µg/dL 9 weeks
Primary Testosterone ng/mL 9 weeks
Primary Testosterone to cortisol ratio ng/mL 9 weeks
Primary Urea mg/dl 9 weeks
Primary Creatinine mg/dl 9 weeks
Primary AST U/L 9 weeks
Primary ALT U/L 9 weeks
Primary GGT U/L 9 weeks
Primary LDH U/L 9 weeks
Primary CK U/L 9 weeks
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