Caffeine and sport: recent studies

New interesting evidence related to the involvement of caffeine in sport performance has been published during the last month.

The first of these studies suggests that 6 mg/kg BW caffeine supplementation improves by ~2% rowing (2000 m effort)
performance; combination with sodium bicarbonate seems to prevent performance enhancement, due tu GI side effects.
Further investigation to minimize GI symptoms is required. Health claims on caffeine have received favorable opinions by EFSA but have caused concerns with Member States.
The second one reports that adding 8 mg/kg BM caffeine to postexercise carbohydrate (CHO) feedings seems to improve subsequent high-intensity interval-running capacity compared with CHO alone. This effect may be related to higher rates of postexercise muscle glycogen resynthesis previously observed under similar feeding conditions. In line with EFSA health claim assessment (still controversial with Member States) it may be interesting to suggest on label to take
caffeine supplements after the intake of CHO, or with CHO. Nevertheless the recommended dosage in the study seems to be too high (560 mg/day for a 70 kg person).

In both studies a potential concern seems to be related to the levels of caffeine used. For example EFSA, in its opinions, takes into
account lower levels of caffeine compared to those used in trials; Member States allow lower amounts of caffeine in food supplements (Belgium bans solid caffeine). In Italy, for example, no more than 300 mg/day caffeine are informally allowed.

These studies provide further support to the use of caffeine in sports under some circumstances, although levels may be an issue.

Armando Antonelli – Sport Nutrition Team

European Commission and Member States on food supplement classification, labeling of wine and health claims

‘On 1 February 2012 the EC Standing Commettee on the food chain and animal health met in order to discuss many topics related to the general food law. Below a feedback of main discussions, with Hylo’s point of view.

Status of the products placed on the market as food supplement/dietetic food for special medical purposes

Member States and EC have recently debated whether the same product can be classified and sold as a food supplement and as food for special medical purposes simultaneously by two entities. EC said yes in theory, no in practice, and pointed out that art. 14 of Dir. 2009/39 cannot apply to food supplements (and quite confusingly mutual recognition would not apply).

In Hylo’s view, the borders between the two pieces of legislation are so blurred, especially with the vast discretion Member States exercise in this area, and the national pieces of legislation that they have put together (including Spain), that this will continue to be uncertain. Some Member States have a strong preference for dietetic foods, some others prefer food supplements; and several Member States have consistently refused to accept the interpretation of other Member States (it is unclear if the EC was supporting this attitude with the remark on mutual recognition).

This is unlikely to change as long as dietetic foods exist, or a single process is established. Confusion will continue to persist.

Spermidine and related health claim

The spermidine and prolongation of the growing phase (anagen) of the hair cycle health claim proposed by the Italian pharma company Giuliani Spa (also known for the GABA novel food application) continues to be mired in controversy. EFSA had opined in December 2011 that since the population studied for the claim (and likely beneficiaries) has a pathological condition. So the claim would be medicinal, and not allowed within Reg. 1924/2006.

The EC has commented, and we @Hylo will follow with interest to see how it goes (not well but it’s still uncertain). Whether EFSA is coherent on this matter, given hypercholestoremia is also a disease, it’s another matter that deserves in-depth analysis.

Sugar beet fibre and related health claim

Member States and the EC seem to have agreed to soften EFSA’s wording on sugar beet fibre and increasing faecal bulk. EFSA proposed “Sugar beet fibre increases faecal bulk”, EC and MS decided to say “sugar beet fibre contributes to an increase in faecal bulk”.

We Hylobates observe that it is not unexpected that the direct, simpler style of health claims in the English-speaking world would be rejected at the EU-level where broadly fuzzier claims are favored by regulators. Moreover, this decision signals the intention of regulators to intervene in the wording of claims much more aggresively than could be anticipated. It is not entirely clear that consumers would perceive the two wordings in different ways.

Status of allergens in wine

After the rejection  of scientific studies on allergens in wine presented in order to avoid the application of allergen labeling requirements, there has been much speculation on what would happen. Member States and the EC could not agree on a solution that would make everyone happy. However, the EC indicated that a decision should come soon – and that it should be pragmatic.

Selling of foods beyond maximum durability

Last but not least, Member States discussed the selling of foods beyond maximum durability at the 1st February meeting. Most said it’s possible but it’s also a complex issue. Our view: each Member State will go its own way.

– Sport Nutrition Team –

Focus on Astaxanthin antioxidant properties

Here’s a second post on health claims and oxidant properties. As commented earlier, EFSA is saying that an antioxidant property per se is not a health benefit, as long as it is not shown that there is a direct effect in the body, on proteins, DNA or lipids. EFSA also argues that only some markers have been validated to show this type of direct beneficial effect on the body’s antioxidant defence network. Astaxanthin is an interesting case-study caught in the middle. EFSA has rejected an application because ‘although astaxanthin has antioxidant properties in vitro, the human studies presented do not provide any evidence in support of an in vivo antioxidant effect in terms of lipid peroxidation following the consumption of astaxanthin’. A recent study, according to the authors, provided support to “benefical effects on the oxidative stress markers in overweight adults”. If we focus on markers, the authors have used: malondialdehyde (MDA), isoprostane (ISP), superoxide dismutase (SOD), and total antioxidant capacity (TAC). Changes in F2-isoprostanes (ISP) in 24-h urine samples in considered the gold standard as direct measurement of lipid peroxidation. TAC has not been evaluated by EFSA. MDA and SOD can be used as supportive evidence in addition to reliable in vivo techniques. The concept itself of “beneficial effects on oxidative stress markers” is rejected by EFSA; if there is no protection of macromolecules in the body, there is no benefit. Companies and scientists seeking to support health claims are warned. Of course science goes its own way.

Sport Nutrition Team

Oxidative damage (included UV-induced): health claims guideline.

EFSA has published a guidance to explain what are the scientific requirements for health claims referring to: antioxidant, oxidative damage and cardiovascular health.

First of all EFSA states (in accordance with Reg. 1924/2006) that the 2 main requirements to substantiate a claim are that the claimed effects have to be considered as a beneficial physiological effects and that it must be supported by adequate studies in humans.

In the first part of the document the status of ‘antioxidant’ is discussed: the concept of “antioxidant” as a benefit is rejected, but this aspect will be discussed more specifically in another post.

Regarding protection from oxidative damage, which can be claimed and is intended as proven protection of body cells and molecules (i.e. DNA, proteins and lipids) from oxidative damage, EFSA established some general requirements to substantiate these claim with reference to all the cellular structures:

–          An appropriate method of assessment should be able to determine accurately and specifically the oxidative modification of the target molecule in vivo (at least an appropriate market of oxidative modification needed).

–          A marker (method) cannot be accepted for substantiation when (technical) limitations are considered to be severe.  

 Then, as reported above, the food/constituent has to show a real beneficial effect on target molecules and it has to be demonstrated by  setting up adequate scientific studies, involving humans. Below the methods accepted to validate the beneficial physiological effect, specific for every different cellular body:

–          Proteins: the only validated method to detect oxidative damage is HPLC-MS. Proteins by products analysis (ELISA or other colorimetric methods) shows some limitation, then they cannot be considered valid alone, but just in combination with other direct methods.

–          Lipids: F2-isoprostanes in 24-h urine samples is the recommended method. LDL oxidised particles (using specific antibodies) and phosphatidylcholine hydroperoxides (using HPLC) are validated methods as well. Not allowed markers: reactive substances (TBARS), malondialdehyde (MDA), lipid peroxides, HDL-associated paraoxonases, conjugated dienes, breath hydrocarbons, auto-antibodies against LDL particles, and ex vivo LDL resistance to oxidation).

–          DNA: recommended method is the modified comet assay which allow the detection of oxidised DNA bases (e.g. use of endonuclease III to detect oxidised pyrimidines). Conventional comet assay and other methods are not suitable.

Other methods still widely used to measure antioxidant properties are to be considered worthless in the perspective of health claims. This applies to the evaluation of past studies, and future studies of benefits of food.

Armando – Sport Nutrition team

Health claims & unlikely friends: vitamin maximum levels, and borderline with medicines

As noted in an earlier post, health claims are producing, or trying to produce, effects in food law. Member States are fighting any resulting harmonization, with mixed results.

For example, in theory, maximum levels of vitamins have nothing to do with health claims, and are notoriously one of the least harmonizable bits of food supplement law.

EFSA gave a favourable opinion on the effects of vitamin D and the reduction of the risk of falling, which is a risk factor in the development of bone fractures. EFSA also set conditions of use of 20μg of daily intake of vitamin D. This of course was not well taken by those EU Member States who have a deep dislike for high vitamin levels. The European Commission (EC) decided to go back and ask EFSA if those levels are safe. Assuming EFSA will say that they are, it will be interesting to watch how the vote on the health claim authorization goes, and how the regulation on this claim will be enforceable in some MS.

The other interesting bit would seem deeply confusing to most people. If there is a EU law stating that you can say that food A provides a certain benefit B to humans, then most people would assume that  food A can be legally sold across the Union.

However, this is totally wrong, as several Member States remarked at the December 5 meeting. Member States have the right to say that food A is a medicine in their country, so it cannot be sold there as a food, and you cannot claim that benefit B. While this seems very complex, the European Court of Justice has said that it is ok, so the EC will have to play along and add a recital clarifying this.

In any case, it is clear that winning EFSA’s approval is not the end of the story.

– Sports Nutrition Team –

PS: the implementing rules for art. 8 of Reg. 1925/2006 (ie, possibility to restrict use of other subtances, such as aminoacids, botanicals, etc)  moved forward. We expect some trouble from this. Germany’s request to list substances that cannot be used in food has for the moment been sidelined.

What does “light” mean? How far can the lack of nutrient profiles be pushed?

According to European Union Regulation 1924/2006, also known as the Nutrition and Health Claims Regulation (NHCR), the claim fat-free can be made when:

“A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0,5 g of fat per 100 g or 100 ml. However, claims expressed as ‘X % fat-free’ shall be prohibited.”

For example, a line of dairy products with 0,1 g of fat per 100 g can make such a claim,  can express it also as 0,1% fat, and may have features bordering on ligthness (without mentioning it, otherwise it would have to meet the requirements of reduced which are:
A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30 % compared to a similar product, except for micronutrients, where a 10 % difference in the reference values as set in Directive 90/496/EEC shall be acceptable, and for sodium, or the equivalent value for salt, where a 25 % difference shall be acceptable


That said, no fat or low fat claims do not imply that the product has low energy. With nutrient profiles practically dead (art. 4), this would seem ok, even when with the same “no fat” product line you have some flavors with low calories and some other flavors that practically have the same energy of the regular, full fat line. The consumer may think that the “no fat claim”, especially comparing superficially the two existing product lines, would imply a signficant reduction of energy as well , but this would be irrelevant from a regulatory standpoint.

Is it really so, or could it fall under the scope of misleading advertising? Authorities in at least some EU countries have proved ready to question a strict interpretation of Reg. 1924/2006, and fine companies under a broader interpretation, as int eh case of % cholesterol claims. Cholesterol content claims would be allowed under the Regulation’s annex, but appear to conflict with the principles of the Regulation.

Predictions are difficult to make, and we suggest caution with approaches as the one described (i.e., use the lack of profiles to push for products that are light only in appearance), especially for sports nutrition, which is often a soft target for regulators.

Sports Nutrition Team

Alimenti per sportivi vicini all’abolizione

La Commissione Europea ha presentato proposta formale di abolizione della categoria “alimenti per sportivi” perché non è stato possibile fissarne le caratteristiche a livello comunitario. La destinazione d’uso per sportivi ricadrà dunque nell’ambito nazionale, secondo l’interpretazione delle norme vigenti, mentre i prodotti saranno ricompresi in altre categorie, dagli integratori agli arricchiti. La proposta dovrà essere vagliata da Consiglio e Parlamento.

The balanced and varied diet in action

Health claims can be made in advertising  only if a statement indicating the importance of a varied and balanced diet (and a healthy lifestyle) is included, according to EC Regulation 1924/2006. Of course, a possibility – when TV commercials are concerned – is to add on-screen text. Increasingly, however, this is at least complemented by showing a balanced meal, generally a breakfast with fruit, juice, milk and, for example, toast. It is a visual statement to the same effect. Though we have seen little use of this approach in the food supplement sector, it is certainly interesting. Recently, UK’s ASA (the Advertising Standards Authority) has upheld a complaintagainst Danone’s Nutricia ad.

While the Authority agreed that Nutricia could not compare their product,  Cow & Gate Growing Up Milk, to other categories of food, it noted “the relevant EC Regulation [Reg. 1924/2006] did not prevent a child being depicted drinking Cow & Gate Growing Up Milk as an accompaniment to a meal, to clearly illustrate the importance of a varied mixed diet in which the product might be one element“. At the same time, a compaint has not been upheld against Ferrero’s Nutella saying on the importance of a varied diet statement: “the ad showed each child eating only one slice of toast with Nutella and that the images also included other breakfast items such as fruit juice, milk and cereal”.

A recent example, in this respect, can be viewed in Italy with Danone’ Danaos ad which, regardless of other comments, shows a balanced breakfast, with juice being poured, etc.

– The Sports Nutrition Team –

Altroconsumo, Federsalus e gli integratori alimentari

No agli integratori alimentari

Nei giorni scorsi si è registrata un’editoriale polemica di Altroconsumo sugli integratori alimentari, partita da un’inchiesta (dei cui meriti non intendo discutere), cui è seguita la replica di Federsalus, con un articolo comparso su che riassume il tutto.

Per chi lavora nel settore, in tutte le componenti della filiera, questi attacchi – quando sono generici ed apodittici – dispiacciono, anche per la confusione che creano nel consumatore, senza in realtà modificarne i comportamenti. Nel mondo degli integratori alimentari – come tanti settori paralleli, da quello del farmaco da banco a quello dell’alimento funzionale – c’è una grande varietà di qualità, efficacia, comunicazione. Indispensabile in questo senso è – e soprattutto sarebbe – un’azione critica, puntuale, basata su dati scientifici ed analitici, da parte del movimento consumerista, a cominciare dall’organizzazione più qualificata, che è Altroconsumo. Ritengo che la qualità di molti prodotti non sia sufficiente e che i controlli vadano incrementati.

Non posso condividere invece l’atteggiamento pregiudiziale che non è solo del movimento consumerista, ma anche di alcuni noti studiosi e personalità. Non è un pregiudizio, nella sua generalità,  basato sui dati scientifici: ci sono buone evidenze che alcuni integratori alimentari funzionano, e fanno bene, anche se, per tanti altri, la comunicazione si è svincolata dal dato scientifico (basta fare un giro in farmacia o leggere il giornale per verificarlo). Come fa notare Federsalus, non si possono poi mettere in luce solo i pareri negativi di EFSA: l’Autorità comunitaria ha ritenuto scientificamente fondati numerosi claim che riguardano gli integratori alimentari, soprattutto su vitamine e minerali (in maniera che non mi trova d’accordo, peraltro). Inoltre, se è vero che la dieta varia ed equilibrata è un obiettivo corretto, è anche vero che non è la realtà di tutti, e, in nome di un ideale corretto, non mi sembra giusto non favorire uno status nutrizionale adeguato, anche se raggiunto mediante l’integrazione. Infine, si ignorano le oggettive carenze di micronutrienti che riguardano anche la popolazione italiana (e di cui si parla pochissimo): dal ferro in numerose donne, all’acido folico, alla vitamina D e alle vitamine del gruppo B negli anziani. Forse serve la fortificazione (che non c’è), spesso modificare la dieta è poco realistico o praticabile e numerose persone potrebbero trarre un significativo beneficio da un’integrazione adeguata, e conforme alle più recenti indicazioni scientifiche.

Se insomma le organizzazioni dei consumatori si occupano di distinguere tra integratore ed integratore, senza proclami generici, fanno un buon servizio al settore industriale, prima di tutto, e, poi, ai consumatori che sono quelli che stanno a cuore a tutti.

Luca Bucchini, Managing Director

Low glycaemic “properties” claims: EFSA brings new hope

Low glycemic “properties” are an industry’s favorite when it comes to sports nutrition, particularly for bars. Though such claims are rather carelessly used in some EU countries, with little official scrutiny, there was concern that claims such as those would not be allowed under Reg. 1924/2006 or would fall outside its scope and hence in a limbo of regulatory uncertainty.

Although the recent batch of EFSA opinions on health claims resulted in several sadly negative opinions, sugar replacers such as xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose came out as clear winners. EFSA’s NDA panel declared that “a cause and effect relationship has been established between the consumption of foods/drinks containing xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose instead of sugar and reduction in post-prandial blood glucose responses (without disproportionally increasing post-prandial insulinaemic responses) as compared to sugar-containing foods/drinks“.

The Panel was apparently convinced that the Regulation’s restrictions on comparative claims as well as art. 3 (“...the use of nutrition and health claims shall not….give rise to doubt about the safety and/or the nutritional adequacy of other foods“, with sugar possibly the loser in this case) did not present a problem, although this may come back at the enforcement level in Member States.

In practice, while the immediate implications of this EFSA opinion vary in different Member States, there is a clear possibility of making “low glycemic” claims on food supplements (e.g., protein with sucralose) and bars with polyols (news which will make many happy).

However, the conditions set by the Panel deserve a careful analysis before using the claims.

– Sports Nutrition Team –

NB: Stevia, which, at the moment, is not allowed anyway, is not in the list.

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