Following an application from Gelita AG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to collagen hydrolysate and maintenance of joint health.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.
The food constituent that is the subject of the health claim is collagen hydrolysate. Complete specifications such as flow chart of the manufacturing process, the typical amino acid profile of the hydrolysate, and stability information have been provided. The Panel considers that the collagen hydrolysate, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “maintenance of joint health”. The target population, as proposed by the applicant, is physically active people. The Panel considers that the maintenance of joints is a beneficial physiological effect.
The applicant provided one narrative review, three intervention studies in humans, one animal study, two in vitro studies, and two bioavailability studies as pertinent to the claim.
The narrative review on collagen hydrolysate for treatment of osteoarthritis and other joint disorders did not contain any primary data which were pertinent to the claim.
One of the human studies on the effects of collagen hydrolysate on the composition of hyaline cartilage was conducted in patients with knee osteoarthritis. The Panel considers that the evidence provided does not establish that patients with osteoarthritis are representative of the target population with regard to the status of joint tissues, or that results obtained in studies on subjects with osteoarthritis relating to effects on the composition of cartilage can be extrapolated to the target population (physically active people without osteoarthritis). No scientific conclusions can be drawn from this study for the substantiation of the claimed effect.
One intervention study with 100 healthy athletes was an open label non-controlled trial. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In a randomised, double-blind, placebo-controlled trial, 147 active student athletes who complained about physical activity-related joint discomfort because of joint stress, injury, surgical outcome, or trauma, received 10 g collagen hydrolysate per day or placebo for 24 weeks. Subjects were randomly assigned to two groups: a group receiving collagen hydrolysate and a group receiving a placebo which contained xanthan. Joint discomfort was recorded at baseline and at 6, 12, 18 and 24 weeks using a visual analogue scale (VAS). A physician rated the following parameters: joint pain at rest, joint pain related to exertion, restricted ability to move, and state of inflammation. Study subjects rated their subjective symptoms using the same VAS: pain when walking, standing, running a straight line, running and changing direction, carrying objects, lifting, extending arms, rotating the shoulder, reaching, throwing, and at rest. The primary end-points of the study (a total of 15) were defined as the baseline adjusted VAS scores after 24 weeks of treatment. Of the 147 subjects recruited, 97 were included in the statistical analysis. The Panel notes that the statistical analysis did not include imputation of the missing data. The Panel also notes that the statistical model did not use all the observed data (i.e. data from all of the visits). All study participants improved, i.e. all experienced decreased pain, during the study. However, there were no significant differences between groups for any endpoint when significance levels were adjusted for multiple comparisons according to Bonferroni-Holm.
One animal study was carried out in a mouse model of osteoarthritis and investigated an effect of orally administered collagen hydrolysate on the development and the progression of osteoarthritis. The Panel considers that the evidence provided does not establish that an effect of collagen hydrolysate on joints in this mouse model can predict an effect on maintenance of joints in humans.
In vitro studies were provided on the effect of collagen hydrolysate on the metabolism of chondrocyte extracellular matrix. The Panel considers that the evidence provided does not establish that effects of collagen hydrolysate on the metabolism of chondrocyte extracellular matrix in vitro predict an effect in vivo.
The Panel considers that the bioavailability studies do not provide evidence for a mechanism for the proposed effect of collagen hydrolysate on joints.
In weighing the evidence, the Panel took into account that one study in physically active humans did not show an effect of collagen hydrolysate on joint discomfort, and that studies in animals and in vitro do not predict an effect of collagen hydrolysate on maintenance of joints in humans in vivo.
The Panel concludes that a cause and effect relationship has not been established between the consumption of collagen hydrolysate and maintenance of joints.