The company says real-world studies like this can provide data that is more “relevant and inclusive.”
Rousselot (Irving, TX) announced publication of a new study conducted on its joint-health ingredient Colartix hydrolyzed cartilage matrix (HCM). The study, now published in JMIR Formative Research, was unique in that it was conducted digitally in patients. The company says “real-world” studies like this can provide data that is more “relevant and inclusive.” The company calls JMIR Formative Research “the leading peer-reviewed journal for digital medicine and care in the internet age.”
“The purpose of this real-world study was to develop a specific mobile app, Ingredients for Life, to conduct a 100% digital study testing the effectiveness of a hydrolyzed cartilage matrix (HCM) supplement on joint discomfort in a heterogeneous group of healthy, active consumers,” the researchers’ study abstract states.
They add: “Protocols assessing the effect of a nutritional intervention on health commonly involve a series of face-to-face meetings between participants and study staff that can weigh on resources, participant availabilities, and even increase dropout rates. Digital tools are increasingly added to protocols to facilitate study conduct, but fully digitally run studies are still scarce. With the increasing interest in real-world studies, the development of health apps for mobile devices to monitor study outcomes is of great importance.”
The 16-week study1 included 201 healthy and physically active women and men aged 18-72 years who reported joint pain. Participants were given blinded study supplements, either 1 g of HCM or 1 g of maltodextrin (the placebo), daily for 12 weeks. They logged joint-pain scores in the mobile app daily, logging their physical activity alongside joint-pain scores using a visual analogue scale (VAS). After that, there was a four-week washout period during which participants continued reporting their joint-pain scores, up until the end of week 16.
The results showed that subjects in the HCM group saw reduction in joint pain within three weeks of taking the HCM supplement compared to the placebo group and regardless of gender, age group, and activity intensity. After all subjects stopped supplementing, the HCM group’s joint pain scores did gradually increase, but they still remained significantly lower than those in the placebo group after four weeks of washout, the researchers reported. The study also saw a low dropout rate of <6% of participants, mainly in the placebo group. This suggests that “the digital study was well received by the study population,” the researchers said.
They concluded that three weeks of oral intake with the low dose (1 g/day) of HCM led to significant reductions in joint pain. They noted: “The digital tool allowed us to measure a heterogenous group of active adults in a real-world setting (without any lifestyle intervention), thus promoting inclusivity and diversity. With low dropout rates, it demonstrates that mobile apps can generate qualitative, quantifiable, real-world data showcasing supplement effectiveness.”
In a Rousselot press release, the company stated that this study “demonstrates how digitally enabled protocols can create more realistic and inclusive clinical study designs that complement standardized clinical trials.”
Janne Prawitt, PhD, Rousselot’s scientific director and one of the study authors, added in the press release, “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. 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.” She added that the digital study allowed the researchers to recruit a wider study cohort than would have been possible with a traditional study design that would have required subjects to travel.