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.

Standing Commitee: choice of analytical method in the way of health claim authorisation

The EC’s Standing Committee on the food chain and animal health (Section on General Food Law) met on 5 December 2011; the minutes have just been released. The discussion seems to have been particularly lively, and shows how the health claims legislation is impacting food law and practices across the EU, and potentially leading to harmonization (which Member States naturally object to).

The first issue on the agenda was a health claim related to slowly digestible starch and its role in on reduction of post-prandial glycaemic responses compared to rapidly digestible starch. The claim received a favourable opinion from EFSA under the new science mechanism (art. 13.5 of Reg. 1924/2006).

The applicant used the Englyst method to characterize the food, and EFSA agreed. Nevertheless, the Commission had doubts on whether Member States (MS) were able to use the method for enforcement. Also, EC officers wondered whether ‘slowly digestible starch’ is understood by consumers across the EU.

In fact, most MS said the method could not be mentiond in the final regulation, since itis not internationally recognized, and that the wording of the health claim should be improved.

In summary, getting EFSA to say yes bring you only half-way, and there is a risk that enforcement of the regulation will be even messier than the EFSA process.

– Sports Nutrition Team –

Art. 13 health claim list regulation will provide reassurances (and worries)

The first outcome of the discussion in Brussels on the 5th of December was that the Regulation with the “big list” under art. 13.1 (the claims which should have been based on generally accepted evidence) will clarify that only health claims on the list are allowed, all others being forbidden, with two exceptions.

The exceptions include “claims requiring further consideration by the risk managers before a decision on them can be taken; claims requiring a further assessment by EFSA; and claims on “botanical” substances; that have not received an assessment by EFSA following a request by the Commission”. Such claims will be listed on the EC website (botanicals, probiotics, caffeine, some odd claims on arginine, one claim on fructose and one claim on glycaemic carbohydrates, etc). Hopefully the text will be clear enough to avoid unwarranted enforcement (and the situation with caffeine is rapidly resolved).

The Committee also accepted that the claims of beta-glucans cannot be extended beyond EFSA opinion (to all beta-glucans); clarified the conditions for use on water-related health claims and on glucomannan; extended health claims valid for some weight loss products to all products complying with Directive 96/8/EC; and said no to a claim on fat and to one on sodium (as they are not beneficial).

On a related matter, providing a spark of hope, the Committee approved a new Regulation refusing market authorisation to some claims. This smaller Regulation will grant  more generous terms extending “the period granted to operators and national controlling authorities to adapt to the new requirements of the draft Regulation to all claims used in commercial communications and not only to those used on the label of products”. There is widespread concern that enacting terms have been too stringent for stakeholders so far, especially when the health claim had legally been on the market for some time. Hopefully, this reasoning will be applied more broadly in the future.

– Sports Nutrition Team –

The effects of low and high glycaemic carbohydrates on endurance performance

The concept of glycaemic index (GI) was originally introduced to classify carbohydrate-rich foods, usually having an energy content of >80 % from carbohydrates, according to the differences in effects on post-meal glycaemia. The GI, which is a nutritional property of a carbohydrate-rich food, is defined as the incremental area under the blood glucose response curve following a 50 g glycaemic carbohydrate portion of a test food expressed as a percent of the response to the same amount of carbohydrates from a standard reference product taken by the same subject (FAO/WHO, 1998).

Carbohydrate-rich foods can be classified according to their GI values (glucose as the standard): high GI >70 (white bread, most white rices, corn flakes, extruded breakfast cereals, glucose); normal GI 55-70 (whole wheat products, basmati rice, sweet potato, sucrose); low GI 40-55 (most fruits and vegetables, legumes/pulses, whole grains, nuts, fructose) and very low <40.

On the other hand, is not easy to outline glycaemic index of foods rich in carbohydrates because many other factors in the diet (e.g. amount and type of dietary fibre, amount of dietary fat, energy density, physical properties, mode of preparation) are involved.

EFSA (European Food Safety Authority) expressed its negative opinion on the substantiation of health claims related to carbohydrates that induce low/reduced glycaemic responses and carbohydrates with a low glycaemic index. The claims effect was related to carbohydrates with a low glycaemic index (GI) and Impact on blood glucose / Glycaemic control / Glycaemic response or to maintain healthy cholesterol levels. The main cause of rejection of these claims was that the food constituents, carbohydrates that induce a low/reduced glycaemic response and carbohydrates with a low glycaemic index (e.g. <55), which are the subject of the health claims are not sufficiently characterised. On the other hand, there are also positive opinions concerning natural and artificial sugar replacers such as xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt and sucralose for which EFSA approved the claims related to consumption of these substances and reduction of post-prandial glycaemic responses, furthermore the same opinions have been given for slowly digestible starch in starch-containing foods, beta-glucans from oats and barley and others.

Concerning this topic a recent human trial study has highlighted effects relevant to sportsmen. The study involved 10 well trained cyclists to investigate the effects of high and low glycaemic index (GI) 24 h recovery meals on the physiological responses and subsequent athletic performance, following a glycogen depleting protocol.

On day 1, subjects performed a glycogen depleting protocol after which they then consumed either high or low GI recovery diets over the next 24 h, which provided 8 g.kg BWˉ¹ of carbohydrate. On day 2, the subjects returned to the laboratory, 2-3 h postprandial, to perform a 40 km time trial (TT) on the Velotron cyclePro© ergometer. The results showed no significant differences between the two groups of subjects with respect to both physiological parameters (carbohydrate, fat oxidation and blood glucose concentration) and related to endurance performance.

The study suggests that type of carbohydrate intake (low GI or high GI carbohydrate) does not affect performance. This calls into question some long-standing formulation principles, and requires further research. The available evidence strongly supports carbohydrate intake in the context of sports; the final word on the use of low GI carbohydrates over high GI carbohydrates had not been said, and high GI carbohydrates still have a place.

Jacopo Angelucci – Sport nutrition Team

Leucine plays a key-role in protein synthesis during moderate steady state exercises

Leucine is one of the essential amino acids (EAA) and belongs to the group of BCAAs (branched chained amino acids), the only ones (together with Isoleucine and Valine) that are not degraded in the liver. BCAAs are found mainly in the skeletal muscle and offer an important contribution to the muscle building. Studies suggest that leucine offers the greatest contribution to the energy production at muscular level, slowing the degradation of the tissue by stimulating muscle protein synthesis. In fact, through the insulin-pathway signaling, leucine seems able to trigger muscle anabolic process.

Nevertheless, EFSA‘s Panel on Dietetic Products, Nutrition and Allergies (NDA) published a scientific opinion regarding BCAAs, providing a negative opinion related to the proposed claims, such as ‘Growth or maintenance of muscle mass’, ‘Faster recovery from muscle fatigue after exercise’ and ‘Reduction in perceived exertion during exercise’, noting that there was no proof of benefit over that of all aminoacids as protein building blocks. Some countries, however, are still allowing claims to be made on leucine and BCAAs.

A recent study was performed in the US to evaluate how supplementation with essential amino acids containing two different amounts of leucine can influence post-exercise muscle protein synthesis. Eight adults drank two amino acid based beverage containing respectively 1.87 g and 3.5 g of leucine during their physical exercises. Muscle protein synthesis was determined by using two stable carbon and hydrogen isotopes as marker. Results showed that muscle protein synthesis was 33 % greater (P < 0.05, then statistically significant) after drinking the leucine-enriched beverage, than after consumption of non-enriched one. This trial suggests that ‘increasing the concentration of leucine in an EAA supplement consumed during steady state exercise elicits a greater MPS response during recovery’. It should be noted however that EFSA has indicated that the markers used are not adequate, as positive effects on muscle mass should be proved via actual measurements of mass, not through markers of degradation or synthesis.

The study supports higher ratios of leucine in BCAA supplements, or increasing the leucine content of supplements and other foods for sportsmen.

Given EFSA’s negative opinion, claims on the effect of BCAAs on muscle protein synthesis (which EFSA said is not a benfit per se) rest on shaky ground. It’s just possible, and only for now, to claim BCAAs effects allowed at national level (e.g. for Italy: ‘trophism and muscle recovery’); this must be checked country by country.

Armando Antonelli – Sport Nutrition Team

Hylobates’ consultants get ready to work with EFSA’s application desk

Hylo’s consulting team is preparing to work closely with the newly created EFSA’s application desk on applications submitted on behalf of clients.   According to EFSA, the mission of the newly created application desk is to act as a front office and support desk for applicants.   The application desk should handle requests of applicants, Member States, stakeholders and other interested parties and register and conduct an initial administrative compliance check on application dossiers, among other duties.  The application desk is part of the new EFSA’s REPRO Directorate whose aim is to provide independent scientific advice related to risk assessment of substances, products and processes intended to be used in the food chain and, substantiation of claims made on foods.

“EFSA is a pillar of food safety and the rule-based food information system in the EU. Working closely with the Authority has always been a priority for Hylobates” according to Luca Bucchini, Hylobates’managing director “Being based in Italy, we are close to the Authority; we scrutinize, seek to understand all its actions. The setting up of the desk is a step in the right direction, in line with the most efficient food administrations in the EU. We believe it will help us aid applicants in a more effective way, rewarding rapidly good applications”.

Hylobates Consulting

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