Rx Nutrition Resource Center
Rx Nutrition Resource Center
January 31, 2019
6 min read

How to encourage nutrition over pills to manage cholesterol

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Elizabeth Klodas 2019
Elizabeth Klodas

Consuming two doses of foods containing high levels of whole food fiber, omega-3 fatty acids and phytosterols per day significantly reduced LDL cholesterol, according to findings presented at the American Heart Association Scientific Sessions.

Fostering dietary changes in patients who are used to taking pills may be difficult, but ensuring that a diet intervention with appropriate foods is practical, affordable and not time intensive may help break through to such patients.

Impact of nutrition on lipid lowering

“Over 70 million Americans are candidates for statin drugs and as many as 20% of statin candidates experience side effects, especially muscle pain, and have very few other treatment options,” Elizabeth Klodas, MD, cardiologist and founder of Step One Foods, told Healio Primary Care Today. “Many patients refuse to take the medications in the first place because they fear developing those side effects. There’s a lot of patients in need of a different solution and no one has really addressed that.”

Most dyslipidemia is caused primarily by diet, yet diet therapy is underutilized in treatment, most likely because it is complicated and time intensive for both health care providers and patients, according to Klodas.

Stephen Devries 2019
Stephen Devries

“Foods that help to lower cholesterol and are heart-healthy in ways that extend beyond cholesterol, are naturally high in soluble fiber,” Stephen Devries, MD, executive director of Gaples Institute for Integrative Cardiology and associate professor of medicine at Northwestern University Feinberg School of Medicine, told Healio Primary Care Today. They include: whole grains, beans, vegetables and fruit and nuts.”

Fostering dietary changes in patients who are used to taking pills may be difficult, but ensuring that a diet intervention with appropriate foods is practical, affordable and not time intensive may help break through to such patients.
Source: Adobe Stock

Klodas and colleagues conducted a multicenter, randomized, double-blind, free-living study to test whether a simple diet regimen that only required twice daily dosing of food containing high levels of whole food fiber, alpha-linolenic acid omega-3 fatty acids and phytosterols would improve lipid profiles among statin intolerant patients.

The foods in the treatment intervention were formulated specifically to lower cholesterol and support cardiovascular health. The intervention products were prepackaged, ready-to-eat, single serving, shelf-stable, familiar foods including oatmeal, pancakes, bars and smoothies. The treatment foods supplied a minimum of 5 g of whole food fiber, 1 g of omega-3 fatty acids, 1,800 mol of antioxidants and 1 g of phytosterols per serving. The control products were matched by category and calories.

Participants were encouraged not to make any other diet or lifestyle changes.

Both interventions were carried out for 4 weeks with a 4-week washout period in between. The researchers drew lipid profiles pre- and postintervention.


Overall, the treatment arm demonstrated an 8.8% decrease in LDL cholesterol and a 5.1% decrease in total cholesterol compared with the control arm.

“Two-thirds of patients in the intervention group saw a clinically meaningful LDL reduction of 10% or more,” Klodas said. “Many attained 20% to 30%, and even close to 40% of LDL lowering with the intervention’s food — those are medication-level results obtained with food.”

The control food did not affect LDL cholesterol, she said.

“Our research shows that even small dietary changes can have profound lipid impacts as long as they are the right ones,” Klodas said. “Food can be used as medicine and a resource for that exists. To our knowledge, Step One Foods is the only such option in the marketplace, but wouldn’t it be great if our research sparked other food companies to undertake development of additional or clinical trial validated food as medicine solutions — this is what we really need.”

“If a clinical issue is being driven in part by food, shouldn’t part of the treatment be to change the food?” she added.

Additionally, a study published in JAMA showed that a vegetarian diet supplemented with plant sterols and psyllium reduced LDL cholesterol by 28% in just 1 month, according to Devries. The diet included about 20 g of soluble fiber from whole grains and beans, 2 cups of soy protein, approximately 28 g of almonds, nearly 4 servings each of fruit and vegetables, psyllium and 2 g of sterol supplements per day, he said.

Encouraging nutrition over pills in practice

One of the reasons why dietary approaches have failed in the past is because they were too complicated and required patients to cook from scratch or become food scientists to understand what they were eating, according to Klodas.

For patients who would rather take a pill than change their diet, physicians need to encourage a dietary approach that meets people where they are, is easy to follow and is not intrusive into patients’ busy lives, she said.

Additionally, affordability is important, she said. The intervention foods in the Step One Foods study cost just over $4 for two servings and are a substitution for other foods, not an addition, she noted.

“What really resonates with patients who are used to pill popping is emphasizing that better nutrition will lead to healthy longevity because ultimately, that is what most people desire from their care and prevention efforts,” Klodas said. “It’s not necessarily having perfect numbers — it’s living long and well.”


“We know based on volumes of data that people who live long and well do so because they eat well, not because they are on the perfect combination of pills,” she continued. “That doesn’t mean that medications aren’t effective or counterproductive. It just means that they are an incomplete solution and if physicians don’t address nutrition and other lifestyle efforts, then drugs are not going to provide the desired outcomes on their own.”

It is transformative and empowering for patients to be successful at dietary changes, according to Klodas. When patients see a measurable benefit for something that they did themselves, it encourages them to make additional positive lifestyle changes, she said.

“Most physicians are used to their patients failing at the nutrition piece, but that is because we’ve provided them with the wrong solution in the past,” Klodas said. “The right solution is a dietary intervention that is simple, convenient and can be easily incorporated into patients’ everyday lives.”

If physicians prescribe food as medicine in that way, they will see huge improvements in their patients’ health, she said.

“The goal of eating healthfully is to maintain vitality and minimize the burden of disease,” Devries said. “There is strong evidence that a diet rich in beans, vegetables, fruit and whole grains is helpful to prevent vascular disease as well as to reduce the risk of recurrence for those who have already experienced a vascular event.”

“In primary prevention, doubling down on dietary and lifestyle factors may eliminate the need for cholesterol lowering medication,” he added. “Even in secondary prevention, where guideline-directed therapy requires statin use, dietary interventions add substantial incremental benefit to improve outcomes.”

It is helpful to remind patients that while statins can reduce the risk of a heart attack by one-third, two-thirds of the risk “still remains on the table” but can be largely addressed by nutrition and lifestyle, according to Devries.

“The debate shouldn’t be about drugs vs. diet — the best medicine involves the optimal use of both,” Devries said.

Addressing the new cholesterol guideline

According to Klodas, the new cholesterol guideline presented at American Heart Association Scientific Sessions devoted little attention to diet when this option should play a significant part.

“Our study shows that certain patients are highly responsive to diet and this could even be predicted based on genetic testing, but practically speaking, patients don’t need a genetic test,” she said. “It only takes a month of eating food to figure out if a patient is a food responder for purposes of lipid lowering.”


Klodas also expressed disappointment that the guideline suggested that the solution for patients with statin intolerance is to simply try to get them to take statins anyway. It is hard to get patients to take drugs that make them feel poorly, she said. Even if patients do start to take them at low doses intermittently, it is rare that they reach their goal, so they would still need additional avenues to improve their lipid profiles and charging $14,000 a year for PCKS-9 inhibitors is not practical or fiscally responsible, she said.

“We are underutilizing the most obvious thing, which is changing the food,” Klodas said. “The beauty of changing food is that it doesn’t come with any side effects, it just comes with side benefits, such as lowering BP, better blood sugar control and weight loss. Food is a comprehensive solution to a complex problem.” – by Alaina Tedesco



Jenkins DJ, et al. JAMA. 2003;doi:10.1001/jama.290.4.502.

Jones PJH, et al. LDL-C response to portfolio foods containing high levels of phytosterols, whole food fiber, and alpha-linolenic acid in statin reluctant patients: Impact of CYP7A1-rs3808607 and APOE Isoforms. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.

Disclosures: Devries reports being the executive director of the educational nonprofit Gaples Institute that offers continuing medical education approved nutrition courses for sale to health professionals. Klodas reports being the founder of Step One Foods.