2042.pdf

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Scientific Opinion on the substantiation of health claims related to mycoprotein and maintenance of normal blood LDL-cholesterol concentrations (ID 1619) and increase in satiety leading to a reduction in energy intake (ID 1620) 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: Mycoprotein   blood LDL-cholesterol   health claims   satiety  
ID:    1620      1619  
Produkty: Mykoproteiny  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is mycoprotein.
Mycoprotein is produced by fermentation of the mould Fusarium graminearum on a carbohydrate substrate (glucose). The production process includes short heat-treatment of the biomass to reduce the RNA content, followed by filtering and drying to a product containing 75 % water. Mycoprotein contains protein (48 % of dry weight), fat (13 % of dry weight) and fibre (about 25 % of dry weight). Beta-glucans comprise about two-thirds of the fibre and the rest is primarily chitin.
The Panel considers that the food constituent, mycoprotein, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effects.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1619)

The claimed effect is “cholesterol maintenance”. The Panel assumes that the target population is the general population.
Low-density lipoproteins (LDL) carry cholesterol from the liver to peripheral tissues, including the arteries. Elevated LDL-cholesterol, by convention >160 mg/dL (>4.1 mmol/L), may compromise the normal structure and function of the arteries.
The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.

2.2. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 1620)

The claimed effect is “reduction in calorie content due to increased satiety”. The Panel assumes that the target population is the general population.
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.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka


3.1. Utrzymanie prawidłowego stężenia cholesterolu LDL we krwi (ID 1619)

One reference provided for the scientific substantiation of the claim described studies on the nutritional value of mycoprotein and on the tolerance of mycoprotein consumption in human subjects, one of which assessed the effect of mycoprotein consumption on total cholesterol concentrations but not on LDL-cholesterol concentrations. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The effects of mycoprotein on serum lipids were studied in the remaining five small intervention studies, two conducted in the UK (Turnbull et al., 1990; 1992) and three in Japan (Homma et al., 1995; Ishikawa et al., 1995; Nakamura et al., 1994). The studies by Homma et al. (1995) and Ishikawa et al. (1995) were available in summary form only. The limited information available on these studies did not allow a complete scientific evaluation by the Panel.
In a double-blind, randomised, controlled trial (RCT) by Turnbull et al. (1992), 21 mildly hypercholesterolaemic subjects (blood cholesterol concentrations >5.2 mmol/L, age 25-61 years) were randomly assigned to consume either eight mycoprotein-containing cookies (n=11, about 27 g dry weight mycoprotein per day) or eight mycoprotein-free cookies (n=10) for eight weeks in free-living conditions. Mycoprotein-containing and mycoprotein-free cookies were comparable with regard to energy content and macronutrient composition, including the amount of dietary fibre. The mycoprotein cookies provided about 4.5 g/day of beta-glucans, whereas the type of fibre in the control cookies was not specified. At the end of the study, total and LDL-cholesterol concentrations were significantly reduced in the intervention group compared to controls (by -0.49 mmol/L, -7.8 % and by -0.50 mmol/L, -12.6 %, respectively), whilst no significant differences between groups were observed with respect to changes in HDL-cholesterol or triglyceride concentrations. The Panel notes the small sample size of the study, and that the observed effect on blood lipids could be explained by the daily amount of beta-glucans provided by mycoprotein.
In a single-blind RCT by Turnbull et al. (1990), 17 mildly hypercholesterolaemic subjects (blood cholesterol concentrations >5.2 mmol/L, age 19-48 years) were randomly assigned to consume either mycoprotein-based foods (n=9) or meat based foods (n=8) for three weeks under controlled metabolic conditions. The amount of mycoprotein consumed in the intervention group was about 190 g/day, corresponding to 49 g dry weight/day. Both diets were comparable with respect to energy and macronutrient composition, but dietary fibre intake in the mycoprotein group was about 11 g/day higher than in the control group. The Panel notes the lack of control for fibre intake and considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In the study by Nakamura et al. (1994), 15 normocholesterolaemic males (blood cholesterol concentrations <5.2 mmol/L, age 25-60 years) were randomly assigned to consume either mycoprotein-containing chips or cookies providing 18 g mycoprotein/day (n=8) or 24 g mycoprotein/day (n=7) for eight weeks in free-living conditions. The Panel notes the lack of an appropriate control group, and that direct comparisons between the two intervention groups were not performed. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In weighing the evidence, the Panel took into account that only one study with a small sample size observed a significant reduction in total and LDL-cholesterol concentrations following the administration of mycoprotein (Turnbull et al., 1992), and that the observed effect could be explained by the daily amount of beta-glucans provided by mycoprotein.
The Panel concludes that a cause and effect relationship has not been established between the consumption of mycoprotein and maintenance of normal blood LDL-cholesterol concentrations beyond the LDL-cholesterol lowering effects that could be expected from the beta-glucan content of mycoprotein.
A claim on beta-glucans and maintenance of normal blood cholesterol concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).

3.2. Zwiększenie sytości prowadzące do redukcji przyjmowanej energii (ID 1620)

Four references were provided in the consolidated list in relation to this claim. All the references reported on human intervention studies which investigated the effects of mycoprotein intake (i.e. as compared to a control protein) on subjective appetite ratings, and measured subsequent energy intake ad libitum (Burley et al., 1993; Turnbull et al., 1991; 1993; Williamson et al., 2006). Some of the studies also assessed possible compensation effects on energy intake at the evening meal (Williamson et al., 2006) or during the next day (Turnbull et al., 1991; 1993). However, all tests were performed on a single occasion, and no conclusions can be drawn from these studies with respect to the sustainability of the effects of mycoprotein consumption on satiety and subsequent energy intake. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of mycoprotein and a sustained increase in satiety leading to a reduction in energy intake.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, mycoprotein, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effect.
Maintenance of normal blood LDL-cholesterol concentrations (ID 1619)
The claimed effect is “cholesterol maintenance”. The target population is assumed to be the general population. Maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of mycoprotein and maintenance of normal blood LDL-cholesterol concentrations beyond the LDL-cholesterol lowering effects that could be expected from the beta-glucan content of mycoprotein.
A claim on beta-glucans and maintenance of normal blood cholesterol concentrations has already been assessed with a favourable outcome.
Increase in satiety leading to a reduction in energy intake (ID 1620)
The claimed effect is “reduction in calorie content due to increased satiety”. The target population 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 consumption of mycoprotein and a sustained increase in satiety leading to a reduction in energy intake.