The study bolsters the potential of Colartix as a joint health supplement. In addition, it demonstrates how digitally enabled protocols can create more realistic and inclusive clinical study designs, that complement standardized clinical trials.
Highlighting HCM’s benefits in a real-world setting
Rousselot partnered with specialists to develop a convenient, user-friendly mobile app, ”Ingredients for Life”, that expands the reach of the randomized clinical trial design and help recruits a heterogenous study cohort of active consumers. A group of 213 healthy and active women and men were selected to log their daily physical activity alongside joint pain scores, using a visual analog scale (VAS)(2), while taking a daily dose of either 1g of Colartix, or 1g of maltodextrin (placebo group). Participants in the Colartix group reported a statistically significant reduction in joint discomfort only 3 weeks into the 12-week supplementation, compared to no reduction within the placebo group.(3) Because of the study’s real-world setting and diverse cohort, researchers were able to observe that participants in the Colartix group all experienced a reduction in joint discomfort, regardless of age, gender and intensity of physical activity.
Following the main study period, participants stopped with the supplementation but continued logging their joint pain for an additional 4-week period. During this time, VAS scores in the Colartix group gradually increased, but still remained significantly lower than those who received the placebo, suggesting persistent benefits even after supplementation ended.
A people-first approach, underpinned by technology
The new study demonstrates Rousselot’s commitment to producing conclusions that are more relevant and inclusive.
“Researchers and physicians investigating solutions to reduce joint pain face a huge challenge. When it comes to proving the efficacy of active ingredients vs placebo in conservative settings with a high level of standardization, results can be difficult to apply to real-world settings,” said Janne Prawitt PhD, Scientific Director at Rousselot and one of the co-authors of the new study. “While traditional, standardized clinical trials are vital from a safety and regulatory compliance point of view, adding digital tools and protocols can clearly enhance inclusion and give a better picture of the consumer experience.”
“What excites us most about the design of our new digitally-enabled study, is that it allowed us to recruit a far wider cohort than would have been possible with a traditional design, which would typically require participants to physically travel to a central location,” Prawitt said. “By allowing participants to record their pain scores on a mobile app, we were able to gather data from groups who might have been underrepresented in the study, such as single parents, people with mobility issues or the elderly. We see digital studies like this becoming a powerful complement to more conventional trials, helping researchers find solutions that are effective for everyone.”
(1) Collagen, Market estimates and trend analysis, 2022 Grand View Research
(2) A visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain with scores recorded by making a handwritten indication on a 10-cm line representing a spectrum ranging from “no pain” to “worst pain”.
(3) C. Newman, et al, “Development of a Mobile App to Monitor the Effectiveness of a Hydrolyzed Cartilage Matrix Supplement on Joint Discomfort: Real-World Study”, JMIR Form Res; 7:e42967, 2023. doi: 10.2196/42967