Hundreds participate in “virtual” energy supplement study at SSW

Over the course of two days at SupplySide West, nearly 500 people took part in what was labeled “history’s fastest clinical trial, start to complete.”

Organized by the contract research organization Radicle Science, the double-blind placebo-controlled study showcased the power of “virtual trials,” or research conducted with little to no human intervention. Instead, subjects interact with their smartphones to submit data via surveys. 

Here’s what the study showed, and what it signified for supplement research, according to its organizers. 

Direct data collection with “nudges”

Visitors to the Radicle Science booth on the SupplySide West show floor were asked if they wanted to participate in a study comparing non-caffeinated energy supplements. I was one of the participants in the trial.

After taking a quick screening quiz covering demographic data, medications, and any potentially disqualifying health conditions, I was deemed eligible and given a capsule and a glass of water by a Radicle Science team member (the supplement or placebo would have been mailed to me in an actual virtual trial). I was told it would contain either a placebo or one of three herbal ingredients.

Over the course of the afternoon, I received five hourly “nudges” via text message, each asking me to follow a link and take a survey. The surveys took about one minute to finish and asked me how many caffeinated beverages I had consumed that day, as well as how strongly I agreed with a series of statements, including:

Related:Experts say survey-based research is highly effective tool, when done properly

Two weeks later, I received an email containing my “Personalized Health Report” stating that my capsule had contained an active ingredient, Rhodiola rosea root extract. According to Radicle Science Communications Director Grace Lightfoot, the other two options aside from the placebo were Asian ginseng, or a multi-ingredient that included theacrine, L-theanine, theobromine, and other botanical extracts and vitamins.

More diversity, better adherence, less overhead

In total, I spent probably 10 minutes participating in the study. But the simple change of putting the data collection in my hand rather than in a lab has profound implications, explained Jeff Chen, M.D., co-founder and CEO of Radicle Science, in an educational session at SupplySide West.

“On the participant's side, 97% of Americans have a smartphone. Boom—they have a supercomputer in their pocket,” Chen said. “When you have physical trial sites, you have intermediaries, you have pen and paper, and there's a lot more room for human error. When you're collecting data directly from the participant, you're asking them in real time how they use it. Their response to that data point is time-stamped, and it’s recorded.”

Virtual trials have become a common part of pharmaceutical research in recent years, but have been slower to take hold in supplement research. Chen predicted their time has come, but not just because of the obvious appeals of lower overhead cost and staff needs. Working directly with consumers, he says, also makes it easier to design high-quality research studies with better adherence, greater diversity and more participants. 

“As soon as you go virtual you can have a larger-scale trial. What does that mean? More power, better chance of beating placebo, greater chance of hitting your claim,” Chen said.

In the weeks following the study, Lightfoot told Natural Products Insider the company has been running statistical analysis on the data set to see if there were significant differences between the active products and placebo. She said the companies that supplied the three products used in the study will decide if they want the results published.