Step One Foods Achieves Major Milestone
On January 26th, 2022 the clinical trial evaluating Step One Foods was published in the Journal of Nutrition. The paper is titled "Reduction in Serum LDL Cholesterol Using a Nutrient Compendium in Hyperlipidemic Adults Unable or Unwilling to Use Statin Therapy: A Double-Blind Randomized Crossover Clinical Trial," and summarizes research performed at Mayo Clinic and the University of Manitoba.
You might be wondering why that’s a big deal. It is after all the same data we already presented at American Heart Association’s national meeting. And nothing has changed. We still yield, on average, a 9% LDL reduction in people using our products, with some seeing 20%, 30% even close to 40% LDL cholesterol drops in just 30 days.
The big deal is that by being published in a highly regarded scientific journal this data is now considered “peer reviewed”. Meaning, it has gone through the same scrutiny afforded drug trials. Clinicians, scientists, and statisticians have looked at our data, picked it apart, and tried to find faults – but couldn’t. In other words, the findings were felt to be sound, real, and plausible and were determined not to have been derived because of faulty trial design or statistical tricks. The findings were also deemed important enough to be memorialized and shared with the larger scientific community.
For me, personally, the publication of the study caps years of hard effort. And I could not be prouder of this accomplishment. No other food company has put itself through this level of scientific scrutiny. And it really was a slog! Although we were simply testing whether eating food could impact cholesterol levels – which seems innocent enough – after all, people eat food all the time and think nothing of getting a blood draw -- we might as well have been evaluating a new form of brain surgery! The levels of regulation, documentation, oversight, and expense were almost insurmountable. Frankly, this whole effort would not have been possible without the significant monetary support from the Government of Manitoba. Or the willingness of the researchers at Mayo Clinic and the University of Manitoba to go above and beyond to get the trial done.
I think this is part of the reason so few studies are performed on food products. The logistics are complex, the barriers are high and there is no patent guaranteeing huge profits and protection against competition at the end.
And that’s why pharma has such a huge advantage and why physicians use drugs so much and so often. All of the published research -- and therefore our treatment guidelines -- are based on evidence from the types of trials that are prohibitive for anyone other than drug companies to do!
But someone had to create a crack in this massive, seemingly impenetrable wall ruled by the pharmaceutical industry. It is gratifying to be able to say that on January 26th, 2022 Step One Foods did just that.
Read more about the journey to the clinical trial in these blog posts:
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