Bioenergy Life Science (BLS) is expanding its use of decentralised clinical research as it looks to help nutraceutical brands generate finished-product evidence more cost-effectively amid increasing regulatory scrutiny of health claims.
The company says its approach will replace traditional site-based contract research organisation (CRO) studies with remote trials in which participants evaluate ingredients and finished products in their everyday environments.
According to the BLS, the model could significantly reduce study costs while producing data that better reflects real-world product use.
Michael Crabtree, General Manager at Bioenergy Life Science, believes the approach addresses a growing challenge for dietary supplement manufacturers.
"When companies want to use our products, we can now say they have been studied using gold-standard protocols such as double-blind, placebo-controlled trials, while being researched in everyday settings," he said.
This enables our partners to build robust safety and efficacy dossiers at a fraction of the usual cost.
The shift comes as regulators continue to emphasise that health-related marketing claims should be supported by competent and reliable scientific evidence.
In 2022, the US Federal Trade Commission (FTC) strengthened its guidance on substantiation for health product advertising, emphasising the need for evidence that directly supports the marketed product rather than relying solely on ingredient-level data.
To demonstrate the new model, BLS recently completed a 30-day decentralised pilot study of 750 mg of its NAD+-boosting ingredient RiaGev-WS in collaboration with Vermont Food Science.
Participants aged 40-59 continued their normal daily routines (without dietary restrictions) or followed tightly controlled dosing schedules.
According to the company, the study achieved a 71% supplement adherence rate, recorded no reported adverse events and generated approximately 85% overall product satisfaction.
Participants also reported perceived improvements in energy, mood, mental clarity and sleep quality, although these findings were self-reported.
The pilot also incorporated what BLS describes as a proprietary dried blood spot assay for measuring NAD+ levels.
Traditional whole-blood NAD+ testing can be difficult because samples require rapid stabilisation, whereas the new approach enables participants to collect samples remotely and send them directly for analysis.
BLS said that the dried blood spot assay recorded an approximately 20% increase in NAD+ after 20 days of supplementation.
The company added that it is now planning a larger 100-participant decentralised study during an eight-week period to evaluate a practitioner-focused formulation combining NAD+ with an additional active ingredient.
As supplement brands face increasing pressure to substantiate product-specific claims while managing development costs, decentralised clinical trials such as this one could become an increasingly attractive option for ingredient suppliers seeking to differentiate their scientific credentials and support commercialisation strategies.
