Cleveland Clinic SPORT trial finds six dietary supplements do not lower cholesterol compared with low-dose statin or placebo

Results from the Cleveland Clinic’s Supplements, Placebo or Rosuvastatin Study presented at the American Heart Association’s Scientific Sessions 2022

On November 6, 2022, results from the Cleveland Clinic’s Supplements, Placebo or Rosuvastatin (SPORT) Study, funded by AstraZeneca, were presented during a late-breaking science session at the American Heart Association’s Scientific Sessions 2022 and simultaneously published in the Journal of the American College of Cardiology. The findings showed that six commonly used dietary supplements marketed for improving heart health, including fish oil, garlic, cinnamon, turmeric, plant sterols and red yeast rice, did not lower ‘bad cholesterol’ when compared to a low-dose cholesterol-lowering medication (a statin) or placebo, and the researchers advise users to reconsider their choice.

Elevated low-density lipoprotein (LDL), also known as bad cholesterol, is a major cause of coronary heart disease, causing build-up of fatty deposits within the arteries that reduce or block the flow of blood and oxygen that the heart needs, which can lead to heart attack or stroke. Many studies show that lowering LDL cholesterol reduces the risk for coronary heart disease.

“Unfortunately, many US consumers believe cholesterol health supplements are safer than prescription medications and believe supplements are as effective, or more effective, than statins.” said Luke Laffin, study author and Co-Director of the Center for Blood Pressure Disorders in the Heart, Vascular & Thoracic Institute at Cleveland Clinic. “If you’re taking over-the-counter supplements for heart health or for cholesterol lowering, you should reconsider.”

The SPORT study comprised of a single-center, prospective, randomized, single-blind clinical trial. 190 adults aged 40–75, with no history of cardiovascular disease, were randomized to 5 mg daily rosuvastatin (a low-dose statin), placebo, fish oil, cinnamon, garlic, turmeric, plant sterols or red yeast rice. The primary endpoint was the percentage change in LDL cholesterol from baseline after 28 days.

Results showed that LDL cholesterol reduction was greater with rosuvastatin (37.9%) than with all supplements and placebo, and none of the dietary supplements demonstrated any significant decrease in LDL cholesterol compared with placebo. Rosuvastatin also had beneficial impact on blood triglycerides (19% decrease vs placebo) and total cholesterol (24% decrease vs placebo), both of which also help reduce cardiovascular risk, whilst all dietary supplements showed no benefit compared to placebo for either. Rates of adverse events were similar across all groups, and no significant adverse changes in liver function testing, estimated glomerular filtration rate, or blood glucose were observed with the use of rosuvastatin.

Marketing of dietary supplements is regulated by the US Federal Trade Commission under the Dietary Supplement Health and Education Act of 1994, rather than by the FDA. Consequently, supplements do not need to meet the standards for safety and efficacy required for marketing of pharmaceuticals.

“Dietary supplement sales are estimated at nearly $50 billion annually in the United States and many supplements are marketed as natural alternatives for heart protection and cholesterol management,” said senior author Steven Nissen, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic. “For management of high cholesterol, supplements are often used by patients in place of statins, in the absence of high-quality data. This represents a major public health concern.”