ID 1522 -
	
		
			Kreatyna
		
		
		
	 
PL: Kreatyna
EN: Creatine
Pdf: creatine
 
        
        
                
1. Charakterystyka żywności / składnika
                
                
                    The food constituent that is the subject of the health claims is creatine.
Creatine is a non-essential nitrogenous organic acid that occurs in vertebrates, and it is also  synthesised in the human body from L-arginine, glycine and L-methionine. Approximately 95 % of  the creatine pool in the body is located in skeletal muscle. The content of creatine in foods can be  measured by established methods.
The Panel considers that the food constituent, creatine, which is the subject of the health claims, is  sufficiently characterised.
                 
                 
	        
        
        
        
        
                
2.1. Zwiększenie wydolności fizycznej podczas krótkotrwałych, powtarzających się ćwiczeń o dużej intensywności (ID 739, 1520, 1521, 1522, 1523, 1525, 1526, 1531, 1532, 1533, 1534, 1922, 1923, 1924)
                
                
                    The claimed effects are “energy metabolism”, “muscular effort”, “bodily constitution”, “increasing  strength”, “increasing mass”, “increasing power”, “increasing performance”, “muscular  effort/recovery”, “increasing time to exhaustion”, and “increasing lifting volume and performance”.  The Panel assumes that the target population is adults performing high-intensity exercise.
In the context of the proposed wordings and the references provided, the Panel assumes that the  claimed effects refer to an increase in physical performance during short-term, high intensity,  repeated exercise bouts. Physical performance relates to the ability to complete certain tasks with  higher intensity, faster, or with a higher power output. Muscle mass and strength are major  determinants of physical performance. In repeated exercise bouts, physical performance is also related  to the ability of muscle to recover faster from high-intensity exercise.
The Panel considers that an increase in physical performance during short-term, high intensity,  repeated exercise bouts is a beneficial physiological effect.
                 
                 
	        
        
        
        
                
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 
                
                
                    The references provided in the consolidated list in relation to the claims evaluated in this opinion  included narrative reviews and book chapters which contained no original data for the scientific  substantiation of the claims, and abstracts and conference proceedings reporting on human  intervention studies in which the information provided regarding the study design, methodology and  statistical analyses was insufficient for a full scientific evaluation. Some of the references reported on  human intervention studies in which creatine was administered in combination with other food  constituents (e.g. carbohydrates, protein, micronutrients and fatty acids) so that the study design did  not allow conclusions to be drawn on the effect of creatine alone. The Panel considers that no  conclusions can be drawn from these references for the scientific substantiation of the claims.
The references provided also included statements/consensus opinions from authoritative bodies such  as the Agence Française de Sécurité Sanitaire des Aliments (AFSSA, 2000), the Scientific Committee  on Food (SCF, 2001), and the American College of Sports Medicine (Terjung et al., 2000). Other  consensus opinions were published by the International Society of Sports Nutrition (Buford et al.,  2007; Kreider et al., 2010) and the American Dietetic Association (Rodriguez et al., 2009). Two meta- analyses of human intervention studies (Branch, 2003; Nissen and Sharp, 2003) and one “systematic  review” (Rawson and Volek, 2003) which addressed the effects of creatine consumption on outcome  measures relevant to the claimed effects evaluated in this opinion, considered the vast majority of  individual human intervention studies submitted for the scientific substantiation of the claims. In  addition, three of the references provided which reported on human intervention studies and which  addressed the effects of creatine on outcome measures related to the claimed effects evaluated in this  opinion were not included in the meta-analyses described below, and will be considered separately as  appropriate (Izquierdo et al., 2002; Ostojic, 2004; Syrotuik et al., 2001).
The purpose of the “systematic review” by Rawson and Volek (2003) was to address the effects of  creatine supplementation and concurrent resistance training on muscle strength and weight lifting  performance. A total of 22 studies, 14 of which were already included in the meta-analysis by Nissen  and Sharp (2003), met the inclusion criteria of Rawson and Volek (2003) and the remaining, except  three (Stevenson and Dudley, 2001; Syrotuik et al., 2000; Syrotuik et al., 2001), were considered in
the meta-analysis by Branch (2003). Two of the three references were provided in the consolidated  list as individual studies (Stevenson and Dudley, 2001; Syrotuik et al., 2001). The Panel notes that the  methodology (e.g. literature search or other strategies used to identify pertinent references, and  methodology used to calculate average percent estimates for increases in muscle strength and weight  lifting performance) used in this review is poorly described and that all the studies included were  already considered in the meta-analyses provided or were submitted separately. The Panel considers  that no conclusions can be drawn from this review for the scientific substantiation of the claims  evaluated in this opinion.
The meta-analysis by Branch (2003) included 96 publications (published up to December 2000) from  100 randomised, placebo-controlled trials, in which at least subjects were blinded to the intervention.
These studies comprised 1,847 subjects. Results were given as means SEM and 95 % CI. Mean
sample size was 19 1 (range 4 to 80). Most of the studies (93 %) were published after 1994, and most  (71 % of the studies) were randomised, double-blind, placebo-controlled interventions which
addressed the effect of an acute ( 14 days) creatine loading regimen (19.7 0.5 g creatine for an
average of 9 1 days) on physical performance in mostly young trained (77 % of the studies) men  (68 % of the studies). Only 22 studies investigated the effects of low dose maintenance creatine  supplementation (>14 days) following acute creatine loading. Twenty-four studies included men and  women as subjects. The effect of creatine supplementation on women was the focus in only 9 studies.  The primary objective of the meta-analysis was to quantify the effect of creatine supplementation on  body composition (including lean body mass) and exercise performance. Performance tasks were  classified as single-bout or repetitive-bout exercises. The first bout of repetitive-bout exercises was
classified as a single-bout exercise task. Performance tasks of 30 sec, 30 to 150 sec, and >150 sec  were also analysed separately. The effect size (ES) of creatine supplementation variable was  calculated for each dependent.
The meta-analysis by Nissen and Sharp (2003) assessed the effects of longer-term creatine  supplementation on lean body mass and muscle strength during resistance training. Only randomised,  placebo-controlled human intervention studies, published in peer reviewed journals between 1967 and  2001, of at least 3 weeks duration and which involved a full-body resistance-training regimen two or  more times per week and were conducted in healthy adults who were not under dietary restriction  were included. A total of 18 studies using creatine alone as intervention met the inclusion criteria.  These studies included a total of 368 subjects (n=180 in the intervention group and n=188 in the  control group) with a mean age of 24 years. All studies had a parallel design, and the sample size in  individual studies was generally small (mean n=10 per group). All studies included were published  between 1997 and 2001. Three studies included men and women, three studies included women only,  and the remaining studies were conducted in men only. Five studies were conducted in untrained  subjects, and 13 studies in trained individuals. The studies averaged 7.5 weeks (range 3-13 weeks) in  duration. The average loading dose of creatine was 19.4 g/day (range 10-21 g/day) for 5.3 days (range  4-7 days), and the average maintenance dose was 6.7 g/day (range 2-10.5 g/day). Changes in lean  mass and strength were normalised for inclusion in the meta-analysis by conversion to percentage  change per week for both treatment and placebo groups. Effect sizes (ES) of lean mass and strength  changes were calculated for each dependent variable. Duration of tasks and task repetition were not  considered in the analysis. All the studies included in this meta-analysis except four (Arciero et al.,  2001; Bemben et al., 2001; Chrusch et al., 2001; Jowko et al., 2001) were already considered in the  meta-analysis by Branch (2003).
These references will be referred to in different sections of the present evaluation as appropriate.
                 
                 
	        
        
        
        
                
3.1. Zwiększenie wydolności fizycznej podczas krótkotrwałych, powtarzających się ćwiczeń o dużej intensywności (ID 739, 1520, 1521, 1522, 1523, 1525, 1526, 1531, 1532, 1533, 1534, 1922, 1923, 1924)
                
                
                    The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows  that there is good consensus on the role of creatine in increasing physical performance during short- term, high intensity, repeated exercise bouts (AFSSA, 2000; Buford et al., 2007; Kreider et al., 2010;  Rodriguez et al., 2009; SCF, 2001; Terjung et al., 2000).
Creatine phosphate (CrP) serves as a readily available source of energy in skeletal muscle and other  tissues. For most exercise situations, the demand for adenosine triphosphate (ATP) is predominantly  provided through oxidative phosphorylation in the mitochondria. However, when aerobic energy  production cannot meet the demand for ATP, anaerobic energy production from CrP hydrolysis and  glycogenolysis/glycolysis is required to assist in the provision of ATP. Such cases include the  transition from rest to exercise, the transition from one power output to a higher power output, and  power outputs above 90-100 % maximal oxygen consumption (VO2max). The rapid  re-phosphorylation of adenosine diphosphate (ADP) from CrP via the creatine kinase reaction may  buffer changes in ATP during transitions between rest and exercise, and may contribute a substantial  fraction of ATP synthesis during short duration, high intensity exercise (AFSSA, 2000; Buford et al.,  2007; SCF, 2001; Terjung et al., 2000).
During a bout of high intensity exercise, the relative importance of CrP hydrolysis to ATP synthesis  falls off as the exercise duration is increased beyond a few seconds. The greatest improvements in  performance following short-term creatine supplementation (5-7 days of ~20 g/day) are found during  a series of repetitive, high power output exercise bouts. Exercise performance during the latter bouts  of a series (e.g. third, fourth and fifth) can be increased by 5-20 % in very high power output exercise  bouts that can be maintained for only a short (seconds) period (e.g. maximal cycling and/or power  jumping), and are separated by fairly brief periods of rest (e.g. 20-60 seconds). Therefore, it is likely  that creatine supplementation improves exercise performance in sport events which require explosive,  high-energy output activities, especially of a repeated nature (AFSSA, 2000; Buford et al., 2007; SCF,  2001; Terjung et al., 2000).
Creatine ingestion increases the total creatine content in human muscle by approximately 15-20 %  (mean value), albeit a high inter-individual variability exists. Such increases can be achieved by  ingestion of 20 g per day for 4-5 days, but also by ingestion of 3 g per day over a period of one month.  The increased creatine content in human muscle is maintained when the ingestion is reduced to 2 g  per day after the original loading period. There is a substantial reduction in urine production on the  first three days of the loading period and this reduction is coincident with the retention of creatine.  The retention of water is thought to be related to an osmotic load caused by creatine retention and to  account for the rapid-onset weight gain experienced by many individuals ingesting creatine. Many  studies have reported increases in body mass of 1-3 kg following short-term (5-7 days) creatine  supplementation (AFSSA, 2000; Buford et al., 2007; SCF, 2001; Terjung et al., 2000).
Longer-term creatine supplementation (e.g. 4 to 12 weeks) in combination with training appears to  increase muscle mass and strength as a result of an improved ability to perform high-intensity exercise  via increased CrP availability (Buford et al., 2007; SCF, 2001).
The meta-analyses and individual intervention studies provided in the consolidated list are consistent  with the above-mentioned consensus. In the meta-analysis by Branch (2003), anaerobic exercise
performance capacity during high-intensity, short-duration exercise ( 30 sec) was significantly
increased by creatine supplementation (617 performance variables; ES=0.24 0.002, 95 % CI=0.20,  0.28; p<0.05), and the majority of the studies considered (45 out of 61) reported an ergonomic effect  of creatine. Significantly more repetitions at specific submaximal intensity/workload (21 estimates;
ES=0.64 0.18, 95 % CI=0.27, 1.00, p<0.05) and greater work capacity (83 estimates; ES=0.21 0.05,
95 % CI=0.11, 0.30, n=83, p<0.05) were performed during consumption of creatine compared to  placebo. ES for repetitive-bout exercise was significantly higher than for single-bout exercise, and  mean ES for percentage decrement in performance over multiple high-intensity bouts was not  significantly different from zero (ES= –0.04±0.06; 95 %CI= –0.16, 0.09), suggesting a resistance to  fatigue between exercise bouts associated with creatine supplementation. The effect of creatine on  overall exercise performance was still significant, but less evident, for tasks lasting 30 to 150 sec
(135 performance estimates; ES=0.19 0.05, 95 % CI=0.10, 0.28; p<0.05), and it was non-significant  for tasks lasting more than 150 sec (ES=0.09±0.07; 95 % CI= –0.04, 0.22). On the other hand, the  meta-analysis by Nissen and Sharp (2003) supports a positive effect of longer-term (3-13 weeks)  creatine supplementation on lean body mass (ES=0.26; 95 % CI=0.17, 0.34, p<0.001) and strength  (ES=0.36; CI=0.28, 0.43, p<0.001) during repetitive resistance training, possibly owing to an  improved ability to perform high-intensity exercise.
In weighing the evidence, the Panel took into account that there is good consensus on the role of  creatine in increasing physical performance during short-term, high intensity, repeated exercise bouts,  and that the meta-analyses and individual intervention studies provided in the consolidated list are  consistent with this consensus.
The Panel concludes that a cause and effect relationship has been established between the  consumption of creatine and an increase in physical performance during short-term, high intensity,  repeated exercise bouts.
                 
                 
	        
        
        
        
        
                
4.1. Zwiększenie wydolności fizycznej podczas krótkotrwałych, powtarzających się ćwiczeń o dużej intensywności (ID 739, 1520, 1521, 1522, 1523, 1525, 1526, 1531, 1532, 1533, 1534, 1922, 1923, 1924)
                
                
                    The Panel considers that the following wording reflects the scientific evidence: “Consumption of  creatine increases physical performance during short-term, high intensity, repeated exercise bouts”.
                 
                 
	        
        
        
        
        
                
5.1. Zwiększenie wydolności fizycznej podczas krótkotrwałych, powtarzających się ćwiczeń o dużej intensywności (ID 739, 1520, 1521, 1522, 1523, 1525, 1526, 1531, 1532, 1533, 1534, 1922, 1923, 1924)
                
                
                    The Panel considers that in order to obtain the claimed effect, 3 g of creatine should be consumed  daily. The target population is adults performing high-intensity exercise.
                 
                 
	        
        
Warunki i możliwe ograniczenia stosowania oświadczenia
Initial phase: 4 Weeks 3g/day, Sustainment: 2-3g/day