RESUMO
BACKGROUND: Clinical evidence has suggested that the oat-soluble fiber ß-glucan might have lipid-lowering effects. OBJECTIVES: The present clinical trial was conducted to evaluate the efficacy and safety of high-medium molecular weight ß-glucan on serum low-density lipoprotein (LDL) cholesterol and other lipid subfractions in subjects with hyperlipidemia. METHODS: A randomized double-blinded trial was performed to assess the efficacy and safety of ß-glucan supplementation in reducing lipid levels. Subjects with LDL cholesterol levels of >3.37 mmol/L when treated or not with a statin were randomly assigned to receive 1 of 3 daily doses of a tableted formulation of ß-glucan (1.5, 3, or 6 g) or placebo. The primary efficacy end point was the change from baseline to 12 wk in LDL cholesterol. Secondary end points of lipid subfractions and safety were also assessed. RESULTS: A total of 263 subjects were enrolled; 66 subjects were assigned to each of the 3 ß-glucan groups, and 65 subjects were assigned to the placebo group. The mean change from baseline to 12 wk in serum LDL cholesterol level was 0.08, 0.11, and -0.04 mmol/L in the 3 ß-glucan groups (P = 0.23, 0.18, and 0.72 compared with the placebo group, respectively) and -0.10 mmol/L in the placebo group. The changes in total cholesterol, small LDL cholesterol subclass particle concentration, non-high-density lipoprotein cholesterol, apolipoprotein B, very low-density lipoprotein cholesterol, and high-sensitivity C-reactive protein were also not significant in the ß-glucan groups when compared with the placebo group. Gastrointestinal adverse events were reported in 23.4%, 34.8%, and 66.7% of patients in the ß-glucan groups and in 36.9% of patients in the placebo group (P < 0.0001 for the overall comparison across the 4 groups). CONCLUSIONS: In subjects with LDL cholesterol levels of >3.37 mmol/L, a tablet formulation of ß-glucan was not effective in reducing LDL cholesterol concentration or other lipid subfractions when compared with a placebo. This trial was registered at clinicaltrials.gov as NCT03857256.
