Creatine in combination with resistance training and improvement in muscle strength: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2016;14(2):4400 [17 pp.].
doi
10.2903/j.efsa.2016.4400
Panel members at the time of adoption
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tome, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Harry McArdle, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Hendrik Van Loveren and Peter Willatts for the preparatory work on this scientific output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of Austria following an application by AlzChem AG
Question Number
EFSA-Q-2015-00437
Adopted
2 February 2016
Published
23 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (1.02 MB)
Abstract

Following an application from AlzChem AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Austria, 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 creatine in combination with resistance training and improvement in muscle strength. The Panel considers that the food constituent, creatine, which is the subject of the health claim, is sufficiently characterised. The Panel considers that improvement in muscle strength is a beneficial physiological effect. A total of 21 human intervention studies and two meta-analyses were provided by the applicant as being pertinent to the claim. The Panel considers that no conclusions can be drawn from 11 studies and the meta-analyses cannot be used for the scientific substantiation of the claim. In weighing the evidence the Panel took into account that, overall, the human intervention studies submitted provide evidence for an effect of creatine, consumed at doses of at least 3 g/day in combination with regular resistance training (three times per week for several weeks) of moderate intensity, on muscle strength in adults over the age of 55, while no such effect was observed when similar doses of creatine on a weekly basis were given on training days only (three times per week). The Panel also took into account the plausible mechanism by which daily consumption of creatine in combination with resistance training could improve muscle strength. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of creatine in combination with resistance training and improvement in muscle strength in adults over the age of 55.

Summary

Following an application from AlzChem AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Austria, 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 creatine in combination with resistance training and improvement in muscle strength.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The general approach of the NDA Panel for the evaluation of health claims applications is outlined in the EFSA general guidance for stakeholders on the evaluation of Article 13.5 and 14 health claims and the guidance on the scientific requirements for health claims related to physical performance.

The food constituent, which is the subject of the health claim, is creatine. The Panel considers that the food constituent, creatine, is sufficiently characterised.

The claimed effect and the target population proposed by the applicant are ‘improvement of muscle strength/muscle function in individuals above 55 years of age who regularly perform resistance training’. Noting that muscle strength is a specific aspect of muscle function, the Panel considers that this claim relates specifically to muscle strength, rather than to muscle function in general. The Panel considers that improvement in muscle strength is a beneficial physiological effect.

The applicant provided 21 human intervention studies and two meta-analyses as being pertinent to the claim.

The Panel considers that no conclusions can be drawn from 11 studies for the scientific substantiation of the claim owing to several reasons (e.g. no control group, absence of appropriate outcome measures for muscle strength). The Panel considers that the two meta-analyses provided, which include intervention studies from which conclusions cannot be drawn, cannot be used for the scientific substantiation of the claim.

From the remaining human intervention studies submitted the Panel considers that, overall, five studies, which investigated the effect of daily consumption of creatine in combination with resistance training on muscle strength, provide evidence for an effect of creatine at daily doses of 3–6 g in combination with regular resistance training (three times per week) of moderate intensity on muscle strength in adults over the age of 55, whereas one study did not show an effect of creatine at daily doses of 5 g for about 7 weeks in combination with resistance training on muscle strength. The Panel considers that four studies, in which creatine was consumed on training days only (three times per week, at doses of 5–7 g/day) in combination with resistance training, did not show an effect of creatine on muscle strength.

In relation to the mechanism by which creatine could exert the claimed effect, the Panel considers that an increase of the creatine phosphate pool in muscle cells following daily consumption of creatine can enhance the ATP regeneration rate after intense muscle contractions. Creatine consumption in combination with resistance training improves the muscle’s ability to train at higher intensities and this leads to higher muscle strength.

In weighing the evidence, the Panel took into account that, overall, the human intervention studies submitted provide evidence for an effect of creatine, consumed at doses of at least 3 g/day in combination with regular resistance training (three times per week for several weeks) of moderate intensity, on muscle strength in adults over the age of 55, while no such effect was observed when similar doses of creatine on a weekly basis were given on training days only (three times per week). The Panel also took into account the plausible mechanism by which daily consumption of creatine in combination with resistance training could improve muscle strength.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of creatine in combination with resistance training and improvement in muscle strength.

The following wording reflects the scientific evidence: ‘daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55’. In order to obtain the claimed effect, 3 g of creatine should be consumed daily in conjunction with a resistance training which allows an increase in the workload overtime. Resistance training should be performed at least three times per week for several weeks, at an intensity of at least 65–75% of one repetition maximum. The target population is adults over the age of 55, who are engaged in regular resistance training.

Keywords
creatine, muscle strength, resistance training, health claims
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Number of Pages
17