Sondaggio utilizzo integratori alimentari

HylobatesConsultingIl team di Hylobates Consulting sta conducendo un’indagine volta a valutare l’andamento globale del mercato degli integratori alimentari in ambito sportivo.

I dati sugli utilizzi e sul mercato degli integratori alimentari per sportivi, compreso il commercio via Internet, sono scarsi. La mancanza di dati impedisce un miglioramento del settore, sia a livello di qualità, che di sicurezza e convenienza, e la sua apertura. Questa indagine è effettuata da Hylobates Consulting srl al fine di comprendere meglio questo mercato.

Ulteriori informazioni possono essere richieste via mail o telefonicamente allo 06 98939628. Ti invitiamo a rispondere a queste poche domande con attenzione per contribuire ad un miglioramento del settore.

Di seguito il link al sondaggio:

– Hylo’s Consulting team –


PlantLIBRA present in University of Buenos Aires’ 14th International Congress of Internal Medicine

“Knowing the benefits, but also the adverse effects of dietary supplements is very important, explained PlantLIBRA project coordinator Prof Patrizia Restani last August 16th as she presented PlantLIBRA in the 14th International Congress of Internal Medicine, a major event in this specialty, in Buenos Aires, Argentina, and organized by PlantLIBRA partner Hospital and Clinics “José de San Martín” of the University of Buenos Aires (UBA). “The idea is not to cause alarm in the population, but to study plant food supplements and communicate if there are potential drug interactions or risk factors to the people who use them”, she added during her presentation. An additional problem was also posed by Prof. Dr. Roberto Iermoli, director of Teaching and Research Hospital and Clinics at UBA, who said that it is common for patients not to mention or deny to their doctor that they consume these products. “When completing the medical history, the doctor has to ask if the patient is using any substance, and the patient should report if they are taking any dietary supplement.” Moreover, in Argentina, only half of the ten dietary supplements of plant origin most consumed would have few reliable studies to convince a good family doctor, wrote Fabiola Czubaj reporting on the conference for the online presence of the newspaper La Nación.

Dr. Raul Pastor, Head of the Section Polyphenols, Wine and Health of the department of internal medicine of the UBA who studies the cardiovascular risks and benefits of supplements and explained the studies on benefits studied by health area by WP2 partners. He stressed as well the importance of effective communication and believes that the project is critical to improve the reference information for regulating the production, manufacturing, and marketing of dietary supplements based on botanicals. “The current situation is critical, with products that are offered and sold through informal channels such as the internet, with misleading advertisements and even toxic content” he continued.

Product quality is also key. So, experts agreed that not even grapefruit juice should be underestimated. “No plant is the problem, but the content of the product and the person has risk factors,” summed up Prof Restani.

The conference titled ”The PlantLIBRA project- Dietary supplements in human health” was organised by PlantLIBRA’s dissemination partners in cooperation with Hylobates Consulting, partner in charge of project management.

The complete article in Spanish tittled “Mitos y riesgos de los suplementos dietarios” can be found by clicking the link

– PlantLIBRA Management Team –

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

Food Colorings maximum levels are going to change

Commission Regulation (EU) 232/2012 (link) establishes new maximum levels for some food colorings, amending the Annex II to Regulation (EC) No 1333/2008. These changes will involve the following dyes: Quinoline Yellow (E 104), Sunset Yellow FCF/ Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124). The  Regulation will apply from 1 June 2013, but food containing these 3 colorings that have been lawfully placed on the market before 1 June 2013 but that do not comply with the provisions of this Regulation, may continue to be marketed until stocks are exhausted.

The reductions in maximum levels mirror the reduced Acceptable Daily Intake (ADI) levels set by EFSA.. and are quite significant.

Several food products are affected. Regarding food supplements the new maximum levels are listed below:

FS supplied in a solid form

E104 from 300 mg/kg to 35 mg/kg
E110 from 300 mg/kg to 10 mg/kg
E124 from 300 mg/kg to 35 mg/kg

FS supplied in a liquid form

E104 from 100 mg/kg to 10 mg/kg
E110 from 100 mg/kg to 10 mg/kg
E124 from 100 mg/kg to 10 mg/kg

FS supplied in a syrup-type or chewable form

Maximum level for all of them is 10 mg/kg (previously not established).

Food businesses should be aware of the changes, and ensure their suppliers are also reformulating in line with the new specifications. It should be noted that in the United States the maximum levels for E110 are not affected (it can be used according to GMPs); E104 and E124 are not permitted in the United States.
– 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

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