Scientific Opinion on the substantiation of a health claim related to citrulline malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Publication, Efsa

doi:10.2903/j.efsa.2012.2699

Cited by 4 publications

(2 citation statements)

References 20 publications

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“…Two applications on citrulline malate and faster recovery from muscle fatigue after exercise were evaluated by the Panel with an unfavourable opinion (EFSA NDA Panel, 2012bPanel, , 2014a. The human intervention studies provided for the scientific substantiation of the claim assessed subjective measures of muscle soreness after strenuous exercise, blood lactate concentrations during exercise and/or perceived fatigue during exercise.…”

Section: Claims On Muscle Functionmentioning

confidence: 99%

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Nutrition¹,

Turck²,

Castenmiller³

et al. 2018

EFS2

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EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.

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Section: Claims On Muscle Functionmentioning

confidence: 99%

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Nutrition¹,

Turck²,

Castenmiller³

et al. 2018

EFS2

View full text Add to dashboard Cite

show abstract

“…The present opinion does not constitute, and cannot be construed as, an authorisation for the marketing of citrulline-malate, a positive assessment of its safety, nor a decision on whether citrullinemalate is, or is not, classified as a foodstuff. It should be noted that such an assessment is not foreseen in the framework of Regulation (EC) No 1924 It should also be highlighted that the scope, the proposed wording of the claim, and the conditions of use as proposed by the applicant may be subject to changes, pending the outcome of the authorisation procedure foreseen in Article 18 (4)…”

Section: Efsa Disclaimermentioning

confidence: 99%

Scientific Opinion on the substantiation of a health claim related to citrulline‐malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Products¹

2014

EFS2

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Following an application from Biocodex, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to citrulline‐malate and faster recovery from muscle fatigue after exercise. The Panel considers that citrulline‐malate is sufficiently characterised. The claimed effect proposed by the applicant is “improved recovery from muscle fatigue”. Faster recovery from muscle fatigue by contributing to the restoration of muscle function after exercise is a beneficial physiological effect. The applicant identified, as being pertinent to the health claim, a total of 35 references, all of which, except for one human study and one animal study, were submitted by the applicant in a previous application for the same food and the same claim. No conclusions could be drawn from the animal study, which was carried out with citrulline only and not with citrulline‐malate. The human study was concerned with blood lactate concentrations after exercise and did not assess muscle function. The evidence provided by the applicant did not establish that a faster reduction of blood lactate concentrations through a dietary intervention leads to faster recovery from muscle fatigue by contributing to the restoration of muscle function after exercise. No conclusions could be drawn from the human study for the scientific substantiation of the claim. A health claim on citrulline‐malate and faster recovery from muscle fatigue after exercise has already been assessed by the Panel with an unfavourable outcome. The additional information submitted by the applicant did not provide evidence that could be used for the scientific substantiation of the claim.

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The effect ofl-citrulline and watermelon juice supplementation on anaerobic and aerobic exercise performance

Cutrufello

Gadomski

Zavorsky

2014

Journal of Sports Sciences

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Citrulline has been proposed as an ergogenic aid, leading to an interest in watermelon given its high citrulline concentration. The aim of this study was to determine the effects of a single, pre-exercise dose of l-citrulline, watermelon juice, or a placebo on the total maximum number of repetitions completed over 5 sets, time to exhaustion, maximal oxygen consumption (VO2max), anaerobic threshold, and flow-mediated vasodilation. A randomised double-blind within-participants study design was used to examine these effects among 22 participants (n = 11 males). Supplementation included either a 7.5% sucrose drink containing 6 g of l-citrulline, 710 mL of watermelon juice (~1.0 g citrulline), or a 7.5% sucrose placebo drink. Supplementation was administered 1 or 2 h before exercise testing to investigate a timing effect. There was no significant effect between the three supplements for the total number of repetitions, time to exhaustion, VO2max, anaerobic threshold, or flow-mediated vasodilation. There was also no interaction observed relative to gender or supplement timing (P > 0.05). A single dose of l-citrulline or watermelon juice as a pre-exercise supplement appears to be ineffective in improving exercise performance; however, greater doses of l-citrulline have been shown to be safe and are currently left unexamined.

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Scientific Opinion on the substantiation of a health claim related to citrulline malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Cited by 4 publications

References 20 publications

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Scientific Opinion on the substantiation of a health claim related to citrulline‐malate and faster recovery from muscle fatigue after exercise pursuant to Article 13(5) of Regulation (EC) No 1924/2006

The effect ofl-citrulline and watermelon juice supplementation on anaerobic and aerobic exercise performance

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