A novel, multi-ingredient supplement to manage elevated blood lipids in patients with no evidence of cardiovascular disease: a pilot study.

Context: Recent changes in usage guidelines have created the potential for millions more Americans to be prescribed statin medications. Caution should be advised because the risk of adverse effects of statins may outweigh their benefits and preclude their preventive use for patients without confirmed cardiovascular disease (CVD) who present with elevated blood lipids. However, statins have shown some benefit in primary CVD prevention. Red yeast rice (RYR) is a dietary supplement that has been demonstrated to reduce low-density lipoprotein (LDL) cholesterol levels in blood and omega-3 polyunsaturated fatty acids have been shown to reduce blood levels of triglycerides (TGs). Although effective, quality control issues aggravate risk of adverse effects for both of these supplements. Furthermore, low dosages per capsule, which require patients to manage and consume many capsules per day, also may reduce patient compliance to supplementation regimens.

Objectives: The authors' objective was to determine the effects of a multi-ingredient supplement (MIS) featuring RYR for primary support of cardiovascular (CV) health in patients who present no CVD history or symptoms other than elevated blood lipids. The MIS was formulated intentionally with a lower dosage of RYR than that used in prior studies in order to reduce the occurrence of adverse effects. Secondary to the objective of managing blood lipids, the authors were interested in determining the effects of the MIS in combination with a high-potency omega-3 polyunsaturated fatty acid supplement and its effect on TG levels and observing whether adverse effects would inhibit patient compliance.

Design: The research team designed an open-label pilot study following a pre-post pragmatic design. Setting • The study took place at 2 primary care settings.

Participants: Nineteen patients with hypercholesterolemia were participants in the study. All participants were required to confirm that they had not taken any other pharmaceutical or supplement therapy to treat cholesterol for at least 30 d prior to baseline, establishing a washout period. At completion of the intervention, 3 participants were excluded for noncompliance with the protocol, although they had taken the supplements as directed.

Intervention(s): The recommended serving of the MIS supplement consisted of 1 softgel that contained 9 ingredients: a proprietary blend of RYR, bioflavonoids, polycosanol, 525 mg omega-3 fatty acids in the natural TG form (294 mg eicosapentaenoic acid [EPA], 147 mg docosahexaenoic acid [DHA]) as well as other supporting ingredients, resveratrol, coenzyme Q10 (CoQ10), folic acid vitamin B3 (niacin), B6, B12, and black pepper. Each serving of the omega-3 supplement contained 834 mg of omega-3 polyunsaturated fatty acids in the natural TG form (484 mg EPA, 234 mg DHA) and 33 IU vitamin E, (D-α-tocopherol). The studys participants were assigned to a group based on their initial TG levels. Participants with TG levels <140 mg/dL took the MIS only, and participants whose initial TG levels exceeded 140 mg/dL were assigned to take both the MIS and the omega-3 supplement, receiving 1384 mg of omega-3 daily (778 mg EPA, 381 mg DHA). All participants confirmed by poststudy survey that they took the recommended serving of 1 softgel/d of the assigned supplement(s) for a minimum of 30 d.

Outcome Measure(s): At baseline and follow-up, standard venous blood labs were drawn and processed at nationally accredited labs. Although not standardized, all reports contained: total cholesterol, high-density lipoprotein (HDL), LDL, and TG levels. The research team acknowledges that this lack of standardization and additional lipid data, such as very low-density lipoprotein, is a limitation of the study.

Results: Total cholesterol and LDL decreased significantly, by 12.0% (P = .0004) and 17.3% (P = .0001), respectively, for the 16 participants taking the MIS supplement. Participants with an LDL at baseline greater than 145 mg/dL (n = 7) benefited even more, with total cholesterol and LDL decreasing significantly by 17.1% (P = .01) and 24.5% (P = .0014), respectively. Although the results were not significant, adding the omega-3 supplement to the protocol resulted in a decrease in the TGs of the subgroup taking both supplements (n = 8), with that measure decreasing by 13.1% (P = .27) from baseline compared with a decrease of 2% (P = .95) for all participants. The subgroup taking both the MIS and omega-3 supplements experienced similar decreases in total cholesterol and LDL as participants taking only the MIS. No side effects were reported by participants, and all participants completed the assigned protocol.

Conclusions: The MIS supplement decreased total cholesterol and LDL significantly and offers a promising therapy for the management of cholesterol that may enable better patient compliance. The addition of an omega-3 supplement also decreased TGs in the subgroup that received both therapies, although this decrease was not significant, potentially because of the underpowered size of the subgroup. The research team plans future studies with more robust lipid testing and larger numbers of participants to support the findings of the current study.