Scientific Opinion on the substantiation of health claims related to protein  
and increase in satiety leading to a reduction in energy intake (ID 414, 616,  
730), contribution to the maintenance or achievement of a normal body  
weight (ID 414, 616, 730), maintenance of normal bone (ID 416) and  
growth or maintenance of muscle mass (ID 415, 417, 593, 594, 595, 715)  
pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]  
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3  
European Food Safety Authority (EFSA), Parma, Italy  
Słowa kluczowe:
Protein
 
bone
 
health claims
 
muscle mass
 
satiety
 
weight management
 
	
	1. Charakterystyka żywności / składnika
	
        
		The food constituent that is the subject of the health claim is protein.
Proteins are important for many body functions (enzyme capacity, antibody action, transport of  various substances) and are major cellular structural elements within the body tissues. Protein can be  used as an energy source and can be measured in foods by established methods. Proteins are  synthesised in vivo in humans from 20 amino acids. Nine of the amino acids are considered as  indispensable, meaning they must be provided by the diet, whereas the rest are categorised as  dispensable as they can be synthesised within the body from other amino acids. Almost all foods of  animal and plant origin contain proteins. Animal dietary sources in particular have a high content of  all indispensable amino acids.
The Panel considers that the food constituent, protein, which is the subject of the health claims, is  sufficiently characterised.
		
	
	
    
	
	
		
 
	
	2. Znaczenie oświadczenia dla zdrowia człowieka
	
        
		
		
	
	
    
	
	
		
			
2.1. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 414, 616, 730)
	
	
			The claimed effect is “satiety/weight management”. The Panel assumes that the target population is  the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to an increase  in satiety. Satiety is the decrease in the motivation to eat after consumption of food. The effect may  persist up to several hours, may reduce energy intake either at the next meal or across the day and, if  sustained, may lead to a reduction in body weight.
The Panel considers that an increase in satiety leading to a reduction in energy intake, if sustained,  might be a beneficial physiological effect.
	
    
			
	
		
			
2.2. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 414,  616, 730)
	
	
			The claimed effect is “satiety/weight management”. The Panel assumes that the target population is  the general population.
Weight management can be interpreted as contribution to the maintenance of a normal body weight.  In this context, weight loss in overweight individuals even without achieving a normal body weight is  considered to be a beneficial physiological effect.
The Panel considers that contribution to the maintenance or achievement of a normal body weight is a  beneficial physiological effect.
	
    
			
	
		
			
2.3. Utrzymanie prawidłowego stanu kości (ID 416)
	
	
			The claimed effect is “bone health”. The Panel assumes that the target population is the general  population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the  maintenance of normal bone through the promotion of calcium absorption.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.
	
    
			
	
		
			
2.4. Wzrost lub utrzymanie masy mięśniowej (ID 415, 417, 593, 594, 595, 715)
	
	
			The claimed effects are “body tissues”, “muscle maintenance and recovery”, “maintenance of muscle  mass of elderly people”, “development of muscle mass of strength athletes”, “reconstruction and  repair of muscle proteins after exercise in endurance athletes” and “supports skeletal muscle protein  accretion”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the growth  or maintenance of muscle mass. Failure to increase muscle mass during growth and development, and  the loss of muscle mass at any age, will reduce muscle strength and power.
The Panel considers that growth or maintenance of muscle mass is a beneficial physiological effect.
	
    
			
	
		
 
	
	3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 
	
        
		
		
	
	
    
	
	
		
			
3.1. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 414, 616, 730)
	
	
			A total of 66 publications were cited for the scientific substantiation of the claim. The references  provided include intervention studies and reviews on the effects of dietary protein on outcomes other  than measures of satiety (e.g. body weight, body fat, serum insulin or blood lipid profile). The Panel  considers that no conclusions can be drawn from these references for the scientific substantiation of  the claimed effect. A total of 10 reviews, 14 original articles and a meta-analysis were considered  pertinent to the claim. Six of the original articles were not included within the meta-analysis.
In the meta-analysis by Halton and Hu (2004), 15 studies examined the effects of a protein pre-load  on subsequent energy intake (Ludwig et al., 1999; Barkeling et al., 1990; Araya et al., 2000; Porrini et  al., 1995; Poppitt et al., 1998; Rolls et al., 1988; Johnson and Vickers, 1993; Booth et al., 1970;  De Graaf et al., 1992; Geliebter, 1979; Porrini et al., 1997; Stubbs et al., 1996, 1999; Teff et al., 1989;  Johnstone et al., 1996), 10 of which also included measures of appetite ratings (Ludwig et al., 1999;  Barkeling et al., 1990; Araya et al., 2000; Porrini et al., 1995; Poppitt et al., 1998; Rolls et al., 1988;
Johnson and Vickers, 1993; Booth et al., 1970; De Graaf et al., 1992; Geliebter, 1979; Porrini et al.,  1997; Stubbs et al., 1996, 1999; Teff et al., 1989; Johnstone et al., 1996). Six of the studies provided,  which were not contained within the meta-analysis, also examined the effects of a protein pre-load on  subsequent energy intake (Latner et al., 1999; Williams et al., 2006; Harper et al., 2007; Lang et al.,  1999), two of which also included measures of appetite ratings (Harper et al., 2007; Lang et al.,  1999). Generally the studies followed a standard design and used two isocaloric pre-loads differing in  protein (and at least one other macronutrient content) which were presented to participants on  separate (single) occasions typically utilising a randomised crossover design. Subjects were followed  several hours later and given access to ad libitum meals.
The Panel notes that in all the studies presented that investigated the effects of protein pre-loads on  appetite ratings and subsequent energy intake, aiming to control for the energy content of the  intervention and “control” pre-loads, the study design does not allow conclusions to be drawn on  whether the effects observed are owing to dietary protein or to the concomitant modification of  carbohydrate and/or fat intakes; it is impossible to vary dietary protein, carbohydrate and fat content  independently of one another using a single control pre-load. The Panel also notes that none of these  studies has tested the sustainability of an effect of dietary protein on appetite ratings and subsequent  energy intake (i.e. effects were tested on a single occasion and no information has been provided on  the repeated consumption of the food constituent). The Panel considers that no conclusions can be  drawn from the studies provided for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary  intake of protein and a sustained increase in satiety leading to a reduction in energy intake.
	
    
			
	
		
			
3.2. Udział w utrzymaniu lub osiągnięciu prawidłowej masy ciała (ID 414,  616, 730)
	
	
			A total of 66 publications were cited for the scientific substantiation of the claim. The references  provided included intervention studies and reviews on the effects of dietary protein on outcomes other  than measures of body weight (e.g. body fat, serum insulin or blood lipid profile). The Panel considers  that no conclusions can be drawn from these references for the scientific substantiation of the claimed  effect.
A total of 11 publications reporting on human intervention studies and one meta-analysis (Halton and  Hu, 2004) which included 15 randomised and controlled studies aiming to investigate the effect of  high protein intakes on body weight in humans were provided. Only three of the original articles  provided were not included in the meta-analysis, two of which addressed the effect of protein intake  on weight loss (Weigle et al., 2005; Leidy et al., 2007), and one of which addressed weight  maintenance after weight loss (Westerterp-Plantenga et al., 2004).
Out of the 17 individual studies considered by the Panel that addressed the effects of protein intake on  weight loss, 10 addressed the effects of protein intake against one other macronutrient on body weight
using energy-restricted (and energy controlled) diets, and were generally of short duration ( 10  weeks, except Farnsworth et al., 2003; Luscombe et al., 2002, 2003). Nine of these studies controlled  for fat intake (i.e. protein was compared to carbohydrates; Baba et al., 1999; Worthington and Taylor,  1974; Layman et al., 2003; Piatti et al., 1994; Whitehead et., 1996; Farnsworth et al., 2003; Luscombe  et al., 2002, 2003; Leidy et al., 2007), and one controlled for carbohydrate intake (protein was  compared to fat; Weigle et al., 2005). One additional study, which controlled for fat intake, was  conducted ad libitum for six months (Skov et al., 1999). The study which controlled for carbohydrate  intake also had an ad libitum phase (Weigle et al., 2005). The remaining six studies manipulated all  three macronutrients (and sometimes energy) simultaneously in the intervention (high protein) diet  with respect to the control (low protein) diet (Brehm et al., 2003; Yancy et al., 2004; Alford et al.,  1990; Parker et al., 2002; Samaha et al., 2003; Foster et al., 2003). Four of these studies used an ad
libitum approach (Brehm et al., 2003; Yancy et al., 2004; Samaha et al., 2003; Foster et al., 2003) and  were of longer duration (i.e. six months). The Panel notes that these studies do not allow conclusions  to be drawn about the role of protein per se (i.e. independently of other dietary manipulations) on  body weight control because the intervention and control diets prescribed differed in aspects other  than the protein content, which could have an impact on body weight changes. The Panel considers  that no conclusions can be drawn from these references for the scientific substantiation of the claimed  effect.
One study was provided which investigated the effect of a protein supplementation on body weight  maintenance after weight loss (Westerterp-Plantenga et al., 2004). In a randomised parallel design,  148 adults followed a very low-energy diet (2.1 MJ/day) during four weeks. At the end of the weight  loss phase, subjects were randomised to consume either 48.2 g/day of protein in addition to their diet  or no supplemental protein in the context of a weight-maintenance programme (dietary counselling)  for three months. Both groups had the same frequency of visits and received the same counselling on  demand by the dietitian. Part of the additional protein was administered as a meal replacement to be  dissolved in water in order to obtain a milkshake, pudding, soup or muesli as part of an ad libitum  lunch (17 g protein, 0.7 MJ/day) and as calcium caseinate (31.2 g protein, 0.5 MJ/day) to be dissolved  in water resulting in two vanilla drinks. The Panel notes the short duration of the weight maintenance  phase, that the composition of the meal replacement was not reported, and that the design of the study  does not allow conclusions to be drawn on the effects of protein per se (i.e. independently of other  dietary manipulations) on body weight control. The Panel considers that no conclusions can be drawn  from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary  intake of protein and contribution to the maintenance or achievement of a normal body weight.
	
    
			
	
		
			
3.3. Utrzymanie prawidłowego stanu kości (ID 416)
	
	
			The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows  that there is good consensus on the role of protein in growth, development and maintenance of bone.  It is well established that a source of protein is essential for allowing both growth and maintenance of  bone. In humans, normal growth is slow and the dietary requirement to support growth is low in  relation to maintenance needs, except at very young ages. While at 18 years of age and beyond protein  requirement for deposition is only 1-3 % of the average total requirement, it is one sixth of the  average total requirement at 1 year of age. Borderline inadequate protein intakes in infants and  children are reflected in failure to grow in length or height. Maximum peak bone mass is reached  between the ages of 25 to 35 years. Thereafter, there is a gradual decrease with age. Inadequate  protein intakes in adults and elderly people may lead to an increased risk of bone loss and subsequent  osteoporotic fractures. Protein requirements of older infants, children and adolescents have recently  been re-determined by the factorial method based on estimates of maintenance requirements and rates  of protein deposition during periods of growth, corrected for inter-individual variability and efficiency  of utilisation (IoM, 2005; WHO, 2007). There is no evidence of a benefit of additional protein  consumption above the amount found in otherwise nutritionally complete diets (WHO, 2007).
The Panel concludes that a cause and effect relationship has been established between the dietary  intake of protein and maintenance of normal bone.
	
    
			
	
		
			
3.4. Wzrost i utrzymanie masy mięśniowej (ID 415, 417, 593, 594, 595, 715)
	
	
			The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows  that there is good consensus on the role of dietary protein in the maintenance of whole body lean body  mass, including muscle mass. Maintenance of lean body mass is achieved if (protein) nitrogen intake  is equal to (protein) nitrogen losses over a period of time. It is well documented that protein intake
(essential amino acids) is necessary to maintain nitrogen (protein) balance as nitrogen is lost from the  body primarily via the urine, but also in small amounts via faeces, sweat, skin, hair and nails.  Similarly, maintenance of muscle mass is achieved if mean muscle protein synthesis rate is equal to  mean muscle protein breakdown rate over a period of time (SCF, 1992; AFSSA, 2007; NNR, 2004;  WHO, 1985, 2007; IoM, 2005).
Dietary reference values (DRV) for protein have been defined by national and international bodies for  children, adults and elderly people in a context of energy balance and moderate physical activity  (SCF, 1992; AFSSA, 2007; NNR, 2004; IoM, 2005; WHO, 2007). Protein intakes within the DRV  allow for normal protein turnover and muscle recovery after physical exercise.
The Panel concludes that a cause and effect relationship has been established between the dietary  intake of protein and the growth or maintenance of muscle mass.
	
    
			
	
		
 
	
	4. Uwagi do zaproponowanego brzmienia oświadczenia
	
        
		
		
	
	
    
	
	
		
			
4.1. Utrzymanie prawidłowego stanu kości (ID 416)
	
	
			The Panel considers that the following wording reflects the scientific evidence: “Protein contributes  to the maintenance of bone”.
	
    
			
	
		
			
4.2. Wzrost lub utrzymanie masy mięśniowej (ID 415, 417, 593, 594, 595, 715)
	
	
			The Panel considers that the following wording reflects the scientific evidence: “Protein contributes  to the growth or maintenance of muscle mass”.
	
    
			
	
		
 
	
	5. Warunki i możliwe ograniczenia stosowania oświadczenia
	
        
            
            - 
            
                Białko przyczynia się do wzrostu lub utrzymania masy mięśniowej
                
            
            
 
            
            - 
            
                Białka przyczyniają się do utrzymania prawidłowej budowy kości
                
            
            
 
            
        
		The Panel considers that in order to bear the claims a food should be at least a source of protein as per  Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced  diet. The target population is the general population.
		
	
	
    
	
	
		
 
Wnioski
	
		On the basis of the data presented, the Panel concludes that:  
The food constituent, protein, which is the subject of the health claim, is sufficiently  characterised.  
Increase in satiety leading to a reduction in energy intake (ID 414, 616, 730)  
The claimed effect is “promotion of satiety”. The target group is assumed to be the general  population. An increase in satiety leading to a reduction in energy intake, if sustained, might  be a beneficial physiological effect.  
A cause and effect relationship has not been established between the dietary intake of protein  and a sustained increase in satiety leading to a reduction in energy intake.  
Contribution to the maintenance or achievement of a normal body weight (ID 414, 616, 730)  
The claimed effect is “weight management”. The target group is assumed to be the general  population. Contribution to the maintenance or achievement of a normal body weight is a  beneficial physiological effect. 
A cause and effect relationship has not been established between the dietary intake of protein  and contribution to the maintenance or achievement of a normal body weight.  
Maintenance of bone (ID 416)  
The claimed effect is “bone health”. The target population is assumed to be the general  population. Maintenance of normal bone is a beneficial physiological effect.  
A cause and effect relationship has been established between the dietary intake of protein and  maintenance of normal bone.  
The following wording reflects the scientific evidence: “Protein contributes to the  maintenance of bone”.  
Growth or maintenance of muscle mass (ID 415, 417, 593, 594, 595, 715)  
The claimed effects are “body tissues”, “muscle” and “maintenance of muscle mass of elderly  people”. The target population is assumed to be the general population. Growth or  maintenance of muscle mass is a beneficial physiological effect.  
A cause and effect relationship has been established between the dietary intake of protein and  the growth or maintenance of muscle mass.  
The following wording reflects the scientific evidence: “Protein contributes to the growth or  maintenance of muscle mass”.  
Conditions and possible restrictions of use  
The Panel considers that in order to bear the claims a food should be at least a source of  protein as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily  consumed as part of a balanced diet. The target population is the general population.