Substituting a portion of existing diet with a specially-formulated snack twice daily for 4 weeks leads to significant reduction in LDL-cholesterol (LDL-C) levels compared with similar control foods matched for calorie in patients with elevated LDL-C who are unable or unwilling to take statins, according to a study.

The modified snacks were specially formulated with Step One Foods—containing bioactive compounds known to have cholesterol-lowering potential such as phytosterols, antioxidants, fibre, and ALA*.

“Based on the outcomes seen in our study, using this type of ‘food as medicine’ approach expands the options for medical professionals and patients,” said lead author Dr Stephen Kopecky from the Mayo Clinic in Rochester, Minnesota, US. “Many patients who are unwilling or unable to take statin drugs may be able to help manage their high cholesterol, or hyperlipidaemia with a realistic food-based intervention.”

In the double-blind, multicentre, free-living crossover study, 54 participants (mean age 49 years, mean LDL cholesterol 131 mg/dL) were instructed to consume a variety of ready-to-eat and hedonically pleasing snacks twice daily to substitute for something they were already taking, for 4 weeks. These snacks were all interchangeable with regard to the nutrients of interest — such as to provide ≥5 g fibre, 1,000 mg ALA, 1,000 mg phytosterols, and 1,800 µmol antioxidants per serving. Control products were similar items matched for calorie from the supermarket. They were strongly discouraged from making any other changes in diet or lifestyle.

Consumption of intervention snacks led to significant reductions in LDL cholesterol by 8.80 percent (p<0.0001) and total cholesterol by 5.08 percent on average, compared with control foods. [J Nutr 2022;152:458-465]

“The magnitude of decrease in LDL cholesterol as a primary endpoint is promising, especially given that some participants experienced 20 percent or greater LDL cholesterol reductions,” said the Kopecky and co-authors. “For every 1 percent that we can lower our LDL cholesterol, we lower the risk of a heart attack or cardiac death by 1 percent in 5 years.”

The researchers also analysed the participants by single-nucleotide polymorphisms (SNPs) for CYP7A1-rs3808607 and APOE, which have been associated with differential lipid responses to phytosterol or fibre. They found no significant associations between these SNPs and the outcomes observed (p≥0.230).

In addition, no significant differences were seen for other analytes such as triglycerides, HDL cholesterol, insulin, serum glucose, and hsCRP concentrations between the two groups.

Overall compliance to the intervention snacks was high, at a rate of 95 percent. ALA concentrations in circulating plasma rose significantly during the active intervention phase — further affirming that the snacks were indeed consumed.

“The overall high compliance of 95 percent with study foods seen in our free-living study is a major advantage of this approach, underscoring the feasibility and ease of including two servings of hedonically acceptable snacks toward achieving risk reduction goals,” the researchers pointed out.

These snacks included oatmeal, cranberry bars, chocolate bars, granola, pancakes, and smoothies, which delivered the nutrients of interest mentioned above.

“Nutrition contributes to five of the seven modifiable risk factors for heart disease, but getting patients to change diet is incredibly challenging,” said study co-author Dr Elizabeth Klodas from Preventive Cardiology Clinic in Edina, Minnesota, US.

“This study underscores what’s possible when we succeed. The implications of attaining such a significant cholesterol impact from a small food based intervention are profound. We could change the health of our country in 30 days,” she stated.