Rousselot’s research app supports inclusive clinical trial for joint health supplement
11 May 2023 --- Rousselot has developed a user-friendly mobile app, ”Ingredients for Life,” that expands the reach of the randomized clinical trial design of its Colartix hydrolyzed cartilage matrix (HCM) supplement and helps recruit heterogenous study cohorts of active consumers.
Digital study designs leverage new technologies and promote more inclusive research. “In particular, digitally enabled protocols allow recruitment of a wider and heterogeneous cohort study – in terms of age, gender and activity level – in a more cost-effective way than conservative methods,” Janne Prawitt, Ph.D, scientific director at Rousselot and one of the co-authors of the new study, tells NutritionInsight.
People do not have to physically travel to a central location, which allows data to be gathered from groups who might be underrepresented in clinical studies, such as single parents, people with mobility issues or the elderly.
Mobile apps can generate qualitative, quantifiable, real-world data to showcase supplement effectiveness. “For these reasons, digital tools and protocols are becoming a valid complement to more conventional trials,” explains Prawitt.
Digital protocols
Rousselot first showcased the Colartix ingredient, made from naturally occurring collagen peptides and glycosaminoglycans (GAGs), at Vitafoods Europe 2022.
The digital study, published in the Journal of Medical Internet Research, raises the supplement’s profile and demonstrates the benefits of digitally enabled protocols and creating more realistic and inclusive clinical study designs that complement standardized clinical trials.
“The study was conducted through the creation of a mobile app. It encourages participants to stick to the weekly questionnaire in the long run. In addition, the app enables direct interaction between participants and the HCP through Q&A sessions via calls, messages and video calls,” explains Prawitt.
Two hundred and thirteen healthy and active people were selected to log their daily physical activity alongside joint pain scores, using a visual analog scale (VAS) while taking a daily dose of either 1 g of Colartix or 1 g of maltodextrin (placebo group).
Rousselot’s digital protocol study has been published in the Journal of Medical Internet Research.
Participants in the Colartix group reported a statistically significant reduction in joint discomfort three weeks into the 12-week supplementation, compared to no reduction within the placebo group.
Because of the study’s real-world setting and diverse cohort, researchers would observe that participants in the supplementation group all experienced a reduction in joint discomfort.
Importance of real-world settings
After the study period, participants stopped supplementing but continued logging their joint pain for an additional four-week period. During this time, VAS scores in the Colartix group gradually increased but remained lower than those in the placebo group.
“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,” says Prawitt.
While traditional and standardized clinical trials are vital from a safety and regulatory compliance point of view, adding digital tools and protocols can enhance inclusion and give a better picture of the consumer experience.
“There are several aspects to consider when applying the results to real-world settings. It is essential to rely on the right partner to access reliable participants. Recruitment can pose some challenges: people don’t interact directly with researchers, which may lead to a higher dropout rate,” Prawitt explains.
“To balance this out and get reliable results, it is necessary to recruit a larger number of participants. Last but not least, developing a comprehensive digital tool is also one of the biggest challenges of real-world settings.”
The digital design allowed researchers to recruit a more comprehensive cohort, which is a limitation of a traditional design that requires people to be at a central location. The app allows researchers to find people who would usually be underrepresented, such as single parents, people with mobility issues or the elderly.
By Inga de Jong
