Packed with fiber, plant sterols, antioxidants and omega-3 fatty acids, the diverse portfolio of snacks and breakfasts in Step One Foods’ portfolio were designed and are clinically proven to reduce factors contributing to heart disease, which affects 121 million Americans.
In this episode of FoodNavigator-USA’s Soup-To-Nuts podcast, Klodas explains how after 20 years of prescribing pills that helped control her patients’ heart disease but made them feel worse, she adopted a food as medicine approach. While effective, she acknowledges selling food as medicine is complicated given FDA regulations that limit health claims and insurers’ reticence to cover treatments with hard to measure impacts. But she also notes that attitudes in the US about food as medicine are shifting and the concept is quickly gathering support.
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A new approach to a mounting age-old problem
Klodas says she understands why so many healthcare providers and insurers are hesitant to promote or cover the cost of a food as medicine because she too was once skeptical. But she explains after talking to patients for more than two decades about the root causes of heart disease and seeing the negative side effects from effective pharmaceuticals she came around to the idea that dietary changes can be just as effective as drugs in some cases.
“Eighty percent of heart disease is preventable. It needs not exist… And if you peel it all back, what I treat all day long is the downstream effects of poor diet, because high cholesterol, high blood pressure, high blood sugar, diabetes, excess weight and poor nutrition – these are all major, major risk factors for cardiovascular disease and they are all driven in part or in whole by food,” Klodas said.
But, she added that she – like most health care providers – were not trained to talk with patients about nutrition, but rather to use pharmaceuticals as a change agent.
It wasn’t until she realized that the medications she was prescribing were helping patients on paper only that she began talking to them about their diet and discovering that much of what they ate contributed directly to their conditions and that changing their nutrition could just as effectively change their lives.
“I sent my patients to nutritionists, I have them cookbooks, I gave out pamphlets, I recommended websites, and the patients that did it, it was astonishing … I was affecting cures for the first time,” she said.
But she also recognized that following dietary changes is hard, and to make it easier she created Step One Foods.
“The whole idea behind Step One Foods was to make it super easy. Take all the guesswork out of it, put in the food components that are missing in most people's diets, but are critical to cardiovascular health prevention, and especially lipid management, which is what I see a lot of I see a lot of high cholesterol … and guess what? It works unbelievably well and works really quickly,” she said.
Taste, convenience remain essential
Like pharmaceuticals, though, food as medicine only works if patients eat it, which is why Klodas says she created a range of familiar products to fit different taste and texture preferences.
Included in the line up are snack bars with appealing flavor combinations, including chocolate chip, instant oatmeal, pancake and smoothie mixes and the brand’s take on granola.
All are “super simple to use,” and deliver at least 5 grams of whole food fiber from oat bran, chia, flax and walnuts, and “boatloads” of antioxidants, at least one gram of ALA omega-3 fatty acids and plant sterols, she said.
Clinical research is the alpha and omega of Step One Foods
To know how much of each ingredient to include in Step One Foods’ products, Klodas turned to the existing clinical research, but she didn’t stop there – she also tested the efficacy of her products instead of medication in a clinical trail conducted by Mayo Clinic and the University of Manitoba, which was published in the Journal of Nutrition late last year.
The randomized controlled clinical trial assigned participants to eat in a random order Step One foods or foods matched from general grocery marketplace that were matched for type and calorie count with a washout period in between. They were not restricted in any other way or encouraged to change other behaviors during the trial.
The results showed in 30 days an 8.8% reduction in LDL (bad) cholesterol, a 5.8% reduction in total cholesterol and a .95% increase in HDL (good) cholesterol, according to the study.
Go-to-market strategy balances DTC, explores provder recommendations
Explaining to consumers the health benefits of Step One Foods’ products and introducing the still unfamiliar idea of ‘doses’ rather than servings of foods can’t easily be summed up in a catchy two or three word claim that fits on the front of a pack, which is one reason why Klodas says the company is focused on e-commerce.
The company’s direct-to-consumer website also includes a blog with articles that walk consumers through the basics of cholesterol, how to lower their cholesterol with different approaches, including diet. The results of the company’s clinical trial are also on the website in an easy-to-digest format.
Step One Foods also provides information on its website for clinicians, employers and insurers, which Klodas says in an area that the company will push more aggressively into now that the clinical study is published.
“My ultimate goal is for this to be something that physicians recommend,” but that requires clinical evidence of benefit and consistent and precise intake of key nutrients so providers can measure their patients response, said Klodas, adding Step One Foods offers this.
Up next: Winning over insurers
For the idea of food as medicine to take off in the US, Klodas argues insurers also must participate and cover the cost of prescriptions, the same way they do for drugs. And, she says, she sees “rays of hope” that insurers are starting to treat some foods the same as they do drugs.
“I am determined to have foods such as ours be covered in part or in whole by insurance because if you’re going to pay for the drugs that treat a condition, why wouldn’t you pay for the foods that address the underlying condition?” Klodas said.
She added from a cost perspective, covering Step One Foods could save thousands of dollars per patient annually, which resonates with insurers’ goals.
Step One Foods is ready to ‘start shouting from the rooftops’
Many of the consumers who have tried One Step Foods agree with Klodas that the brand’s approach to food as medicine is a no brainer, and they are voting with their dollars even without help from insurers.
Since 2017, the snack food brand reports it has seen 40-fold revenue growth and has helped improve heart health and reduce the risk of cardiovascular events for 25,000 people. And most of this growth has come from patients seeking alternatives to medicine and actively seeking out One Step Foods.
Klodas says she hopes to build on this momentum in the coming years by investing more meaningfully in outreach and marketing, which has been on the backburner while the company invested instead in clinical research. But with that finally published, she says the company is in a fun spot where it can “start shouting from the rooftops” about the benefits its products offer.
Klodas also plans to expand the brand’s portfolio to include more savory options, including – hopefully – a cracker that she says she has been working on for years and is now ready to scale.
As she continues to build the business in the coming years, she says she is optimistic and eager to see the overall food as medicine movement growing thanks to initiatives like those championed by the White House during the recent conference on hunger and health and the work of other brands piloting projects with insurers and health care providers.