Bioenergy Life Science Commits to Decentralized Research Model

Bioenergy Life Science announced that it is now committed to a decentralized research model for its ingredients, and finished products containing them. Rather than using contract research organization (CRO) settings, the company is drastically reducing costs, helping partners achieve clinical backing for finished products.

“When companies want to use our products, we can now say they have been studied using gold-standard protocols and researched in everyday, real-world settings,” said Michael Crabtree, ND, general manager. “It will enable BLS customer partners to build robust safety and efficacy dossiers at a fraction of the usual cost.”

Unlike conventional, brick-and-mortar CRO trials that require participants to report to a physical research site, decentralized studies allow participants to test supplements in their own homes.

“While a classic 100-person CRO trial can easily cost millions, a decentralized trial may cost roughly one-tenth that amount. By controlling for multiple variables, traditional CROs create artificial environments that may not be applicable in real life. Decentralized trials eliminate these restrictions, closing the gap between laboratory success and how consumers actually use products in real life,” Crabtree said. “We are reporting exactly what participants reported to us, with no interpretation. The data remains very viable for peer-reviewed publication while building a dossier that demonstrates a product is safe and effective.”

The move comes at a time when regulatory agencies express that they are concerned about claims made based on individual raw ingredients, and not finished products.

“The FTC has been very clear. It wants to see scientific evidence done on the finished product. Very few companies in the industry saw this shift coming, but BLS has anticipated the move and we have prepared a viable path forward for our customer partners,” Crabtree said.

Case Study

In collaboration with Vermont Food Science, BLS executed a 30-day decentralized pilot study evaluating 750 mg of RiaGev-WS. There were no dietary restrictions, no strict dosing schedules, and no imposed controls. The small group of adults between 40 and 59 were able to try the supplement and go about their daily lives.

According to the company, there was a 71% adherence rate to the supplement protocol, zero reported adverse side effects, and a product satisfaction rate of 85%.

“Participants reported notable perceived improvements in mood, energy, mental clarity, and sleep. Nearly everyone seemed to get something out of it,” said Crabtree.

At-Home Sampling Methods

Measuring NAD+ in traditional whole blood samples is notoriously difficult, due to samples being hard to preserve and challenging to stabilize for consistency.

BLS worked with partners to create the first-ever dry blood analysis assay test kit to measure NAD+ levels, enabling subjects to send blood samples directly to BLS for analysis.

“The study demonstrated that RiaGev works at a remarkably low dose, with an approximately 20% increase in NAD+ over just 20 days. This low-dose efficacy proves the product is highly effective across a very broad, diverse range of people,” Crabtree said.

An upcoming study will feature 100 participants, utilizing a practitioner-quality formula containing NAD+ and another active ingredient, to evaluate cumulative impact on participants over eight weeks.

“Studying the finished product in this decentralized manner is more affordable, excellent for marketing, and built to withstand regulatory scrutiny,” Crabtree said. “If you are going to operate in the NAD+ space and want to protect your brand, you need to work with us.”