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Healthcare providers: you can have samples sent to your patients at no charge — an evidence-based, food-first tool backed by a Mayo Clinic-led randomized controlled trial.
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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 — before prescribing non-statin therapies for LDL-C lowering. Step One Foods is a suite of ready-to-eat whole foods designed to deliver meaningfully impactful levels of fiber, plant sterols, antioxidants and omega-3 fatty acids, and has been documented to significantly lower LDL-C in a multicenter, multinational RCT.
Our clinical trial has been peer-reviewed and published
Practitioners may request a full digital copy of the Journal of Nutrition article describing the Step One Foods clinical trial.
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 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 5g whole-food fiber, 1g plant sterols, the antioxidant equivalent of 1.5 servings of produce, and 1g omega-3 fatty acids — all derived from real whole-food ingredients, the only fortification being plant sterols. There are no additives, preservatives, colors, or artificial flavors, and nearly all products are sodium-free.
Step One Foods has been subjected to a multi-site, multinational, 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 one-third noting reductions at or above 15%. The maximum achieved LDL-C reduction 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 already eating. A lipid panel is rechecked in 30 days to evaluate cholesterol response — no other lifestyle changes required. Simple for clinicians to explain and administer; for patients it means no point counting, label deciphering, or complex dietary instructions.
It is the easiest, most direct way to test whether a patient can significantly impact their lipid profile through diet. Patients with positive results typically use Step One as their actual first step toward further dietary change — with the ultimate goal of eventually maintaining results without the products.
A clinically-proven adjunct to lipid management
The significant LDL-C reductions observed in the trial were not accompanied by deterioration 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 cardiometabolic 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 healthcare savings based on LDL-C effects alone. The full analysis was published in Current Cardiology Review.
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Learn more about Step One Foods and our practitioner program — including free samples for your patients.
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