Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial

Abstract

Background: The US Food and Drug Administration (FDA) approved health claims for 2 dietary fibers, β-glucan (0.75 g/serving) and psyllium (1.78 g/serving), on the assumption that 4 servings/d would reduce cardiovascular disease risk. Objective: We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease. Design: Sixty-eight hyperlipidemic adults consumed a test (high-fiber) and a control low-fat (25% of energy), low-cholesterol (Results: Compared with the control diet, the high-fiber diet reduced total cholesterol (2.1 ± 0.7%; P = 0.003), total:HDL cholesterol (2.9 ± 0.8%; P = 0.001), LDL:HDL cholesterol (2.4 ± 1.0%; P = 0.015), and apolipoprotein B:A-I (1.4 ± 0.8%; P = 0.076). Applying the Framingham cardiovascular disease risk equation to the data confirmed a reduction in risk of 4.2 ± 1.4% (P = 0.003). Small reductions in blood pressure were found after both diets. The subjects reported no significant differences in palatability or gastrointestinal symptoms between the diets. Conclusions: The reduction in serum lipid risk factors for cardiovascular disease supports the FDA'sapproval of a health claim for a dietary fiber intake of 4 servings/d. Although relatively small in terms of patient treatment, the reduction in cardiovascular disease risk is likely to be significant on a population basis.