Dr. Elizabeth Klodas, a Minneapolis-based cardiologist who trained at the Mayo Clinic and Johns Hopkins University School of Medicine, realized more than a decade ago that conventional medicine wasn’t curing her patients.
“No matter how many drugs I put my patients on, no matter how perfect I got their numbers, no one looked better, no one felt any better,” she told me.
She concluded the missing puzzle piece was nutrition. “I realized, ‘oh my gosh, there’s this whole area of care and good health that’s being missed,’” said Klodas, who launched Step One Foods in 2013 after seven years of product development.
Step OneFoods is a line of mostly plant-based breakfasts and snacks to take the guesswork out of healthy eating for people who need to lower their cholesterol.
To make a difference, patients should ideally consume two servings of Step One products a day as a replacement for other foods in their diet. It’s as simple as, say, eating the pancake mix for breakfast and maybe a dark chocolate crunch bar in the afternoon. Another day, the patient might choose to eat Step One oatmeal with blueberries for breakfast and a strawberry banana smoothie later in the day. The cost is roughly $ 100 a month.
The labels are clean with a focus on healthy, plant-based ingredients that have been shown to lower cholesterol. For example, the tasty cranberry pecan bar features dried cranberries sweetened with apple juice concentrate, date paste, almonds, pecans, chia seeds, oat bran, flax seeds, walnuts, raisins, plant sterols and Saskatoon berries. I’m a particular fan of the pancake mix, made with oats and walnuts.
To be honest, it doesn’t seem all that startling today to talk about the impact of diet on heart health and chronic diseases. But many of Klodas’s patients said she was the first doctor to ask them what they were eating.
Statins are still considered the gold standard for treating high cholesterol by many clinicians, but about 20% of patients can’t tolerate them because of side effects. Other people just don’t want to take medications and may become noncompliant.
Step One’s revenue for the trailing 12 months now stands at about $ 2 million. Klodas said the founders are “not willing to give up control in our company to investors that might not be allied with our mission. Our business model requires only a fraction of the capital of traditional businesses, so a deep-pocketed investor is not required.” Step One sells directly to consumers through its website, avoiding the high costs of getting onto store shelves.
To date, the company has mostly been self-funded. The company raised about $ 500,000 last year from investors in the medical device industry, bringing total funding to $ 600,000, according to Step One’s CFO Bill Alldredge.
The big question, of course, is whether eating just two Step One products a day can significantly impact patients’ health. Signs are encouraging. A clinical study, conducted by the Mayo Clinic and the University of Manitoba, researched how patients fared on Step One products, as compared to a control group. Klodas presented the study’s findings at the November 2018 American Heart Association meeting.
The study was conducted in two, four-week phases. Participants were told to choose two Step One items to eat a day from an assortment of individually packaged snacks as a substitute for foods they were already eating. The products contained at least 1800 mg of alpha-linoleic acid, five grams of fiber and one gram of phytosterols per serving. Participants in the control group ate calorie-matched items from the supermarket that were marketed as heart-healthy or better-for-you. The bottom line: LDL-cholesterol (the bad kind) decreased 8.8% in the group that ate Step One foods, but there was no significant change in the control group’s numbers.
Anecdotal evidence from patients who have tried Step One is encouraging as well. Walter G., 63, who lives in Fairway, Kansas and asked that his last name not be used, considered his doctor’s advice to go on a low-dose statin. But he was reluctant to start medication and decided to try Step One first. He began eating Step One oatmeal every day for breakfast but made no other lifestyle changes. At his last physical in October, his total cholesterol had dropped to 194 compared with 238 the previous year. His LDL cholesterol (the bad kind) had declined to 100, from 130.
Klodas acknowledged that many health-conscious people who already cook from scratch and add heart healthy ingredients such as flax, chia and walnuts to their oatmeal or smoothies may not need Step One. “There is nothing in our food that is inaccessible to people.” she said. “But there’s a huge proportion of people who don’t cook or don’t know how, and they want something convenient and easy.”
About half of new Step One customers make a repeat order. Regular customers spend an average of $ 800 a year.
Like many young companies, Step One’s biggest challenge has been scaling up to meet growing demand. It took a long time to find a co-packer aligned with their mission. Often they wanted to add sugars, other binders and flow agents—additives that can contribute to poor health. “We finally found a great partner, which gives us almost unlimited capacity. Now we are ready to expand,” Klodas said.
In 2020, the company is looking to partner with Medicare Advantage plans and corporate wellness programs to further its reach. “These are significant opportunities for us to really make an impact on the epidemic of chronic disease in this country – with constituencies that have become very open to using nutrition as part of treatment and prevention. Honestly–super exciting,” Klodas said.