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When statins are not enough.

The American College of Cardiology’s 2022 Expert Consensus Decision Pathway advises optimizing nutrition (including increasing fiber and plant sterol intake) prior to prescribing non-statin therapies for LDL-C lowering. Step One Foods is a suite of ready-to-eat whole foods designed to deliver therapeutically impactful levels of fiber, plant sterols, antioxidants and omega-3 fatty acids. SOF has been documented to significantly lower LDL-C in a multicenter, multinational RCT.

The results of our clinical trial have been peer reviewed and published.

Practitioners may request a full digital copy of the Journal of Nutrition article below.

Offer your patients a validated, food-based adjunct for the management of hyperlipidemia.

Our products were developed specifically for patients who are:

  • Ineligible for cholesterol-lowering medications
  • Averse to taking statins due to side effects or personal preference
  • At maximum statin dose with incomplete LDL-C control
  • Unable to maintain dietary or lifestyle changes

The foods were also strategically designed so you know precisely what nutrients are being delivered to your patients and in what quantities. Every serving of every Step One product contains at least 5 g whole food fiber, 1 g plant sterols, the antioxidant equivalent of 1.5 servings of produce and 1 g omega-3 fatty acids. In our foods, these nutrients are derived from real whole-food ingredients, the only fortification being plant sterols. There are no additives, preservatives, colors or artificial flavors. Nearly all products are sodium free.

Step One Foods have been subjected to a multi-site, multi-national randomized, case controlled, cross-over clinical trial in a free-living population of statin intolerant individuals. On average, subjects experienced an 8.8% LDL-C reduction in 30 days, with 1/3rd of patients noting LDL-C reductions at or above 15%. The maximum achieved LDL-C reduction in the clinical trial was 37.6%.

A food-based option to help manage cholesterol is here!

Requiring minimal behavior change, Step One Foods simply asks individuals to consume two familiar, hedonically pleasing, ready-to-eat snacks per day instead of something they are eating already. A lipid panel is then rechecked in 30 days to evaluate cholesterol response. No other lifestyle changes are required. Simple and straightforward for clinicians to explain and administer, for patients it means no point counting, nutrition label deciphering or complex dietary instructions. It is the easiest, most direct way to test whether a patient has potential to significantly impact their lipid profile through dietary adjustment.

Most patients are eager to learn whether they have some control over their lipid profiles and view a 30-day food trial as both approachable and actionable. Those with positive results typically utilize Step One as their actual first step to additional dietary modification which they layer over their Step One program. The ultimate goal is for patients to eventually make enough dietary changes that they no longer need our products to maintain results.

A clinically-proven adjunct to lipid management

The significant LDL-C reductions observed in the trial were not accompanied by deteriorations in other lipid parameters. As expected, given the short duration of the intervention, weight, glucose control and blood pressure control were not impacted.

A range of cardiovascular benefits

Optimizing diet is the most impactful health change a patient can make. Nutrition influences six of the seven modifiable risk factors for cardio-metabolic disease and improving dietary intake can impact them all, including:

  • Lipid profile optimization
  • Improved hypertensive control
  • Reduced inflammation
  • Improved vascular function
  • Improved glycemic control
  • Weight reduction

A cost-effective solution

Actuarial modeling reveals that every $1 spent on Step One Foods would result in $2.32 in health care savings based on LDL-C effects alone.

If you would like to read the full analysis published in Current Cardiology Review, please request your copy below.

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Learn more about Step One Foods and our practitioner program.
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