Scientific Opinion on the substantiation of health claims related to
glucosamine alone or in combination with chondroitin sulphate and
maintenance of joints (ID 1561, 1562, 1563, 1564, 1565) and reduction of
inflammation (ID 1869) pursuant to Article 13(1) of Regulation (EC)
No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Glucosamine
chondroitin sulphate
health claims
inflammation
joints
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is glucosamine, either as glucosamine hydrochloride or as glucosamine sulphate, either alone or in various combinations with chondroitin sulphate.
Glucosamine is an amino monosaccharide where a hydroxyl group (-OH) is replaced with an amino group (-NH2) (2-amino-2-deoxy-D-glucose). The raw material is derived from chitin, a biopolymer present in the exoskeleton of marine invertebrate animals (Foot and Mulholland, 2005). Glucosamine is usually formulated as the hydrochloride salt or as glucosamine sulphate. Glucosamine sulphate is most often the glucosamine-6-sulphate. There are large differences between the hydrochloride and the sulphate compounds regarding biological activity (Foot and Mulholland, 2005).
Chondroitins are glycosaminoglycans consisting of an alternating sequence of D-glucuronate and N- acetyl-D-galactosamine-4/6-sulphate residues linked through alternating bonds. The disaccharide units are joined to one another by a β1-4 linkage. The residues are joined by a β1-3 linkage. Chondroitin is a mixture of different forms. The most common ones are chondroitin-4-sulphate, also known as chondroitin sulphate A, chondroitin-6-sulphate also known as chondroitin sulphate C, and dermatan sulphate, also known as chondroitin sulphate B (Foot and Mulholland, 2005; Šimánek et al., 2005; Lamari and Karamanos, 2006).
The Panel considers that the food constituent, glucosamine, either as glucosamine hydrochloride or as glucosamine sulphate, either alone or in various combinations with chondroitin sulphate, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego stanu stawów (ID 1561, 1562, 1563, 1564, 1565)
The claimed effect is “joints health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that these claimed effects relate to the maintenance of normal joints.
The Panel considers that the maintenance of normal joints is beneficial to human health.
2.2. Ograniczenie zapalenia (ID 1869)
The claimed effect is “immune system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that this claimed effect relates to the reduction of inflammation.
The Panel considers that under certain circumstances the reduction of inflammation might be beneficial to human health.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Utrzymanie prawidłowego stanu stawów (ID 1561, 1562, 1563, 1564, 1565)
A total of 11 human intervention studies (plus one sub-analysis of one of the interventions and one combination of two of the studies), three meta-analyses including most of the individual studies, 21 reviews and background papers, 2 animal studies, one in vitro study, one short report, and one case report were provided for the substantiation of the claimed effect.
Glycosaminoglycans are the major polymers of the ground substance of connective tissue. Glucosamine is a structural component of several glycosaminoglycans other than chondroitin sulphate which is an important structural component of joint cartilage and in part responsible for its resistance to compression. Both glucosamine and chondroitin sulphate are formed in the body. No dietary requirement for the maintenance of the structure (e.g. of cartilage or other connective tissues) or function (e.g. maintenance of flexibility or mobility of the joints) of the joints in healthy humans has been demonstrated by the evidence provided.
All the human studies presented on the effects of glucosamine (either as glucosamine hydrochloride or as glucosamine sulphate), either alone or in combination with chondroitin sulphate, on joint health (e.g. joint pain, joint structure/function) have been conducted in patients with clinical diagnosis of (primarily knee) osteoarthritis (OA). OA is the most common joint disease worldwide (Issa and Sharma, 2006; Corti and Rigon, 2003; Arden and Nevitt, 2006) and a major cause of disability (Hunter et al., 2008; Pollard and Johnston, 2006; Sarzi-Puttini et al., 2005; Ethgen et al., 2004).
The Panel considers that the evidence provided does not establish that patients with OA are representative of the general population with regard to the status of joint tissues, or that results obtained in studies on subjects with OA relating to the treatment of symptoms of this disease (e.g. erosion of articular cartilage, reduced mobility of joints) can be extrapolated to the maintenance of normal joints in the general population.
The Panel also considers that the evidence provided in the animal and in vitro studies submitted does not predict the occurrence of an effect of glucosamine intake, either alone or in combination with chondroitin, on the maintenance of normal joints in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of glucosamine (either as glucosamine hydrochloride or as glucosamine sulphate), either alone or in combination with chondroitin sulphate, and the maintenance of normal joints.
3.2. Ograniczenie zapalenia (ID 1869)
Three review papers on the role of glucosamine sulphate in the treatment of osteoarthritis, one review on the general functions of glucosamine in the body, one review on the effects of glucosamine on markers of inflammation in animal models of acute chemical toxicity, and one animal study on the
anti-inflammatory activity of glucosamine in carrageenan- and cotton pellet-induced acute and sub- acute inflammation in rats were provided to substantiate the claimed effect.
The Panel considers that the evidence provided does not establish that patients with OA are representative of the general population with regard to the inflammatory status of the joint tissues, and that the evidence provided in the animal studies does not establish the occurrence of an effect of glucosamine sulphate intake on inflammation in humans.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of glucosamine sulphate and the reduction of inflammation.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, glucosamine either as glucosamine hydrochloride or glucosamine sulphate, either alone or in combination with chondroitin sulphate, which is the subject of the health claims is sufficiently characterised.
Maintenance of joints (ID 1561, 1562, 1563, 1564, 1565)
The claimed effect is “joint health”. The target population is assumed to be the general population. The maintenance of normal joints is beneficial to human health.
A cause and effect relationship has not been established between the consumption of glucosamine, either as glucosamine hydrochloride or as glucosamine sulphate, either alone or in combination with chondroitin sulphate and the maintenance of normal joints.
Reduction of inflammation (ID 1869)
The claimed effect is “immune system”. The target population is assumed to be the general population. Under certain circumstances the reduction of inflammation might be beneficial to human health.
A cause and effect relationship has not been established between the dietary intake of glucosamine sulphate and reduction of inflammation in the general population.
