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Cholesterol levels fell for people who were given snacks with specific food ingredients without changing the rest of their diets, a small randomized trial showed.

Among non-statin users, LDL cholesterol levels were on average 8.8% lower (116 vs 127 mg/dL, P<0.0001) during the study intervention phase compared with the control phase, in which they were given calorie-matched items from a grocery store, while total cholesterol levels were reduced by 5.08% (204 vs 215 mg/dL, P<0.0001), reported Stephen Kopecky, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues in the .

Treatment foods did not reduce triglycerides, HDL cholesterol, fasting glucose, insulin, or high-sensitivity C-reactive protein, the authors noted.

Compliance to study foods was confirmed to be 95% by serum 18:3n-3 fatty acid concentration assessment.

"Our study documented not only statistically significant lipid profile improvements but also high near-term adherence. This is in contrast to other lipid-lowering dietary interventions such as the , which have attrition rates as high as 25%," Kopecky's group wrote.

"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 Kopecky in a press release from Step One Foods, who provided the study snacks. "Many patients who are unwilling or unable to take statin drugs may be able to help manage their high cholesterol, or hyperlipidemia with a realistic food-based intervention."

These findings may have clinical implications -- the authors cited a suggesting that each 1-mg/dL drop in LDL cholesterol is associated with a 1% reduction in mortality risk.

The study was conducted at the University of Manitoba in Winnipeg and the Mayo Clinic, and included 54 participants (mean age 49 years, two-thirds women) with baseline LDL cholesterol levels averaging 131 mg/dL who were unable or unwilling to take statins. All were non-smokers with no chronic conditions, including congestive heart failure or coronary artery disease.

Participants were randomly assigned to start with either the treatment or control phase. The study's crossover design comprised two 4-week phases separated by a 4-week washout for each participant. Both groups were told not to change their other lifestyle behaviors.

In the treatment phase of the study, participants were given shelf-stable, single-serve snacks with cholesterol-lowering food ingredients (oatmeal, pancakes, cranberry bars, chocolate bars, smoothies, and granola) from Step One Foods, twice daily, as a substitute for a snack they would have eaten anyway. These products required almost no preparation by the study participant. In the control phase, they were given calorie-matched like-items drawn from a grocery store.

The six food options were deemed interchangeable in terms of their nutrients of interest, as they all provided at least 5 g of fiber, 1,000 mg of omega-3 fatty acids, 1,000 mg of phytosterols, and 1,800 μmol of antioxidants per serving.

Of note, participants with CYP7A1 and APOE single-nucleotide polymorphisms did not have different results from the rest of the cohort.

However, "[t]he inability to detect significant effects of genetic polymorphisms in the present study may have been limited by sample size, which was tailored to evaluating LDL cholesterol response. In particular, the CYP7A1-GG carriers were represented by only 8 participants compared with 21 for CYP7A1-TT carriers," Kopecky and team wrote.

They noted the possibility that variations in background diet and study snack choice may have affected outcomes.

"The varied food formats helped meet user preferences, ensuring higher compliance, but may have introduced variations in bioavailability of the active nutrients. Because participants consumed their own choice of combinations of study foods, we could not account for this potential source of variability," the authors noted.

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