EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected Gelita’s “maintenance of joint health” claim because it said, “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.”
In assessing the merits of a trial conducted with 147 active student athletes that were evaluated for 15 parameters related to joint pain/discomfort, the NDA found, “There were no significant differences between groups for any endpoint when significance levels were adjusted for multiple comparisons.”
The NDA opinion can be found here.
Vitabiotics (kind of) wins positive opinion for protein form
In another article 13.5 emerging and proprietary science opinion issued today, the NDA found protein form L-tyrosine could contribute to, “normal synthesis of dopamine”.
But the positive opinion was hedged by an acknowledgement that there was not a sufficient protein deficiency among European Union populations to warrant the claimed effect.
The agency’s health claims team wrote: “…no evidence has been provided that the protein supply in the diet of the European population is not sufficient to fulfil this function of the amino acid.”
The Vitabiotics opinion can be found here.
Key collagen study
In the collagen dossier's key trial, subjects were randomly assigned to two groups: A group (n=73) receiving 25mL of a liquid formulation which contained 10g of collagen hydrolysate and a group (n=74) receiving a placebo, which consisted of 25mL of liquid containing xanthan. During the trial, subjects were permitted to continue taking their regular analgesics or nonsteroidal anti-inflammatory drugs.
Discomfort measured by physicians as joint pain at rest; joint pain related to exertion; restricted ability to move; and state of inflammation was recorded at baseline and at 6, 12, 18 and 24 weeks using a visual analogue scale (VAS) divided in increments of 1 to 10 for severity of symptoms.
Participants ranked the discomfort as 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.
Of the 147, 97 were included in the statistical analysis due to drop-outs, but the NDA said that analysis missed critical data; that joint health improvements between groups were not statistically significant and that a sub-group analysis of 63 subjects with knee arthralgia was not admissible and could not be justified within the aims of the trial.
“The Panel considers that this study does not show an effect of collagen hydrolysate consumption on joint discomfort,” the NDA wrote.