Bioenergy Life Science Adopts Decentralized Clinical Research to Support Nutraceutical Claims

Bioenergy Life Science (BLS) is transitioning its clinical research strategy toward decentralized models to help nutraceutical brands generate product-specific evidence more cost-effectively. This shift comes in response to heightened regulatory scrutiny from the U.S. Federal Trade Commission, which now emphasizes the need for scientific substantiation based on finished products rather than just individual ingredients. By utilizing remote trials that reflect real-world usage, BLS aims to provide its partners with robust safety and efficacy dossiers while significantly reducing the overhead associated with traditional site-based contract research organization (CRO) studies.

Bioenergy Life Science (BLS) is replacing traditional site-based contract research organization (CRO) studies with remote, decentralized clinical trials (DCTs) where participants evaluate products in their daily environments. Michael Crabtree, General Manager at BLS, noted that this approach allows the company to employ gold-standard protocols, such as double-blind, placebo-controlled trials, while gathering data that better reflects real-world product use. This strategic move is largely driven by the U.S. Federal Trade Commission’s (FTC) 2022 updated guidance, which requires manufacturers to provide competent and reliable scientific evidence specifically for the marketed finished product rather than relying solely on ingredient-level data.

To validate this decentralized model, BLS recently conducted a 30-day pilot study in collaboration with Vermont Food Science involving 750 mg of its NAD+-boosting ingredient, RiaGev-WS. The study, which included participants aged 40-59, achieved a 71% supplement adherence rate and reported no adverse events. Findings indicated an 85% overall product satisfaction rate, with participants self-reporting improvements in energy, mood, mental clarity, and sleep quality. Crucially, the pilot utilized a proprietary dried blood spot assay to measure NAD+ levels, a method that allows for remote sample collection and stabilization, showing an approximate 20% increase in NAD+ after 20 days of supplementation.

The success of the pilot has led BLS to plan a larger eight-week decentralized study involving 100 participants to evaluate a practitioner-focused formulation that combines NAD+ with an additional active ingredient. This shift toward DCTs represents a significant trend for the CRO sector, as ingredient suppliers seek more efficient ways to differentiate their scientific credentials and support commercialization strategies. By reducing study costs and streamlining data collection through remote technologies, BLS aims to help its partners build comprehensive safety and efficacy dossiers that meet modern regulatory demands without the financial burden of traditional clinical site infrastructure.