Supplement industry demands human trials to prove ageless vitality science

With a growing aging population and consumers seeking nutrition solutions to accompany their healthy aging journey, the question of product validity among longevity supplements is coming into conversation. 

Nutrition Insight explores the biggest gaps between current ageless vitality claims on the market and the level of clinical or real-world evidence needed to support them with Valio, Akay Bioactives, Sirio Europe, Gnosis by Lesaffre, and Balchem Human Nutrition and Health.

In our previous special report, we revealed how industry leaders are shifting from the “anti-aging” angle to “lifelong vitality or health span,” prioritizing measurable outcomes over vague longevity promises.

As such, R&D is pivoting to science-backed, all-in-one formulations with clinical substantiation, while regulatory demands and consumer specificity drive focus on molecular pathways and personalized nutrition, with companies targeting system-wide resilience.

However, the disconnect between bold market claims and the level of human evidence needed for substantiation is one of the biggest gaps in the ageless vitality space, according to Dr. Anu Turpeinen, Nutrition research manager at Valio.

“Many ingredients promoted for cellular rejuvenation or lifespan extension are still primarily supported by preclinical research, such as cell or animal studies. While these models can provide valuable mechanistic insights, human biology is far more complex, and effects on lifespan in animals do not automatically translate into meaningful outcomes in people.” 

“In addition, many products rely on surrogate or intermediate markers of aging rather than demonstrating direct reductions in age-related diseases or improvements in functional health. Although surrogate markers allow results to be observed within realistic timeframes, there is still limited consensus on what constitutes a robust and validated biomarker of aging.”

She adds that growing human clinical evidence and better agreement on reliable aging markers are key to building long-term credibility in this category.

Invest in dose-relevant human studies

Akay Bioactives’ market development manager, Dr. Trisha Sugarek MacDonald, agrees with Turpeinen that ageless vitality claims rely less on well-designed human trials for the actual material and recommended dose.

Experts note that healthy aging claims outpace human evidence as industry demands clinical rigor.“Consumers today are savvy and more informed than ever. They expect the products they take to deliver benefits they can actually feel. The industry is moving toward clearly defined, measurable endpoints such as reaction time, sleep efficiency, mood changes, hormonal biomarkers, mobility scores, inflammatory markers, microbiome changes, and metabolic parameters.”

“These outcomes are evaluated in randomized, controlled clinical trials using validated assessment tools, clinically relevant biomarkers, and robust statistical analysis,” she details. “Increasingly, they are complemented by real-world evidence and wearable-derived data to enhance translational and practical relevance.”

According to MacDonald, there is an opportunity to narrow the gap by investing in dose-relevant human studies, standardized bioactives, and transparent communication. “When the science and the story align, consumer trust naturally follows.”

Strengthening biomarker validation

Echoing MacDonald and Turpeinen, Sara Lesina, general manager at Sirio Europe, explains that many products rely on biomarkers that are not yet fully associated with meaningful health results.

“Consumers are attracted to visible benefits like improved mobility, cognitive clarity, or reduced inflammation, yet most commercial interventions are still unvalidated at this level.”

“At Sirio, we are addressing this in two ways. Firstly, by establishing rigorous evidence frameworks through the Sirio Institute for Anti-Aging and its partners like the Max Planck Institute, Germany, and King’s College London, UK.”

Sirio aims to move from marketing statement claims to measurable health benefits, backed by clinical data and biomarker validation.

“Secondly, by bridging the gap between the science of those nutrients and the many millions of consumers who stand to benefit from them,” adds Lesina. “That means selecting the right nutrients and delivering them in attractive formats that help people build their longevity regimes.” 

Biomarker validation holds potential to bridge science gaps for credible vitality formulations.“Success only comes in this category when we deliver on both, and that’s our focus.”

Adding nuance

Silvia Pisoni, global operational marketing director at Gnosis by Lesaffre, underscores the necessity of clinical evidence required for vitality claims, which at the moment poses a challenge in the nutraceutical industry.

“While consumer interest in extending healthspan and achieving lifelong vitality continually climbs, clinical validation often lags behind marketing promises, because this validation necessitates long-term clinical evaluation.”

“Additionally, let’s look at a term that is widely used: ‘anti-aging.’ Very few ingredients act as an agent that thwarts, inhibits, or reverses an aging mechanism. However, vitamin K2, as menaquinone-7, can indeed make that claim.”

She specifies that Gnosis by Lesaffre’s MenaQ7, not other K2s, can truthfully state that supplementing with 180 mcg daily for three years results in reversal of arterial calcification. This is seen through pulse wave velocity, the speed at which blood pressure waves travel through the arteries.

“Similarly, SAMe by Gnosis by Lesaffre has demonstrated ability in reversing aberrant DNA methylation patterns, resulting in reduced risk of age-related diseases.”

Cellular health holds promise

Dominik Mattern, VP of Science, Business Development and Marketing at Balchem Human Nutrition and Health, points out more complexities in the ageless vitality landscape.

Mattern points out that many biological mechanisms linked to healthy aging are well established, such as cellular or epigenetic health.“A perceived gap in ageless vitality is often framed as a lack of science behind broad concepts like ageless vitality. In reality, many biological mechanisms linked to healthy aging are well established. Think of terms like ‘cellular health’ and ‘epigenetic health.’” 

“These are becoming central to the healthy aging narrative, grounded in research around mechanisms such as methylation, homocysteine metabolism, and epigenetic processes to whole-body vitality. Here, while methylation and related pathways are well documented in scientific literature for supporting building blocks of life, effectively communicating what this means to consumers can be challenging.”

Mattern further explains that maintaining cellular health across the lifespan is greatly influenced by methylation, a process where methyl groups are added to DNA, acting as molecular switches that can turn genes on or off.

“During adulthood, maintaining healthy methylation patterns helps regulate metabolic processes and stress responses, which are key to healthy aging.”

“Combining a balanced diet with nutrients such as folate, choline, and methylsulfonylmethane that act like methyl donors can promote optimal cellular function throughout our entire lifespan,” he concludes.