Today Step One Foods is presenting its exciting clinical trial findings at American Heart Association’s Scientific Sessions in Chicago – and I can finally share those results with you!
The effort in context: It took 5 years to get to this point. Not because we had to enroll so many participants or because participants had to eat the foods for an extended period of time, but because trials in human subjects, appropriately, are highly regulated and require lots of time-intensive oversight. They’re also very expensive to do and finding funding for a study that yields no patentable data is exceedingly challenging. However, at Step One, we would not be deterred! And, as a result, today we can say objectively that our approach WORKS.
What we did: Our study was composed of two four-week “phases” with a rest period in between. For each phase, 54 participants received a box containing foods packaged in single-serve pouches, together with instructions to consume two servings per day as a substitute for something they were eating already. They were also asked not to change anything else in their daily routines or diets. Cholesterol levels were measured with a blood test before and after each phase. All of the participants were candidates for statin medications, but none were taking the drugs at the time of the study. In one of the phases, study participants were given an assortment of all Step One Foods– ranging from our bars to our smoothie mix. They could eat whatever combination they wanted. In the other phase, they were provided with “control products” consisting of calorie-matched and type-matched “heart healthy” like-items (again ranging from bars to smoothie mix) found in a typical grocery store. Each participant was randomly assigned to start with either Step One foods or the control set. Because all the products were re-packaged into plain pouches, neither the participants nor the investigators knew which set of foods were being tested in either phase until after the results of all the blood tests were in.