1811.pdf

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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  
ID:    595      715      594      730      593      414      415      416      616      417  
Produkty: Białko  

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

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.