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A medical food and phytonutrient supplement improve cardiovascular disease risk factors in subjects with metabolic syndrome and elevated LDL

As cardiovascular disease risk is increased 4–6 fold in subjects when metabolic syndrome (MetS) and elevated LDL occur concomitantly, we evaluated effects of supplementing a therapeutic lifestyle program with a medical food and specific combination of phytonutrients in subjects with both conditions. We analyzed data from subjects with LDL ≥ 160 mg/dL enrolled in a 12‐week, 2‐arm randomized study of 42 adults with MetS, LDL ≥130 mg/dL, triglyceride (TG) ≥150<400 mg/dL and BMI ≥27 kg/m2. Both control (C) and treatment (T) arms consumed a Mediterranean‐style, low‐glycemic‐load diet and engaged in aerobic exercise. T received a medical food containing soy protein and plant sterols and a supplement containing rho iso‐alpha acids and acacia proanthocyanidins. 24 subjects, 12 in each arm, met subanalysis criterion of LDL≥160 mg/dL. At 12 weeks, weight loss did not differ between arms. However, T exhibited greater improvement than C (P<0.05) in total cholesterol, LDL, non‐HDL cholesterol, cholesterol/HDL, TG/HDL, apolipoprotein (apo) B, apoB/apoA‐1, and homocysteine, total LDL and large HDL particle number. All subjects in T but only 1/3 in C achieved LDL <160 mg/dL and 5 in T and 0 in C had LDL lowered to <130 mg/dL. High risk subjects with MetS and LDL ≥160 mg/dL may benefit from a soy/phytosterol containing medical food and phytonutrient supplemented therapeutic lifestyle program. Supported by MetaProteomics, LLC.