An Oat β-Glucan Beverage Reduces LDL Cholesterol and Cardiovascular Disease Risk in Men and Women with Borderline High Cholesterol: A Double-Blind, Randomized, Controlled Clinical Trial. Issue 9 (3rd June 2021)

• Record Type: Journal Article
• Authors: MS Wolever, Thomas; Rahn, Maike; Dioum, ElHadji; Spruill, Susan E; Ezatagha, Adish; Campbell, Janice E; Jenkins, Alexandra L; Chu, YiFang
• Is Part Of: Journal of nutrition. Volume 151:Issue 9(2021)
• Page Start: 2655
• Page End: 2666
• Publication Date: 2021-06-03
• Subjects: randomized clinical trial -- serum cholesterol -- oat β-glucan -- cardiovascular disease risk -- LDL cholesterol; Nutrition -- Periodicals; Diet -- Periodicals; 613.205
• DOI: 10.1093/jn/nxab154
• Languages: English
• ISSNs: 0022-3166

Abstract

ABSTRACT: Background: High-molecular-weight (MW) oat β-glucan (OBG), consumed at 3–4 g/d, in solid foods reduces LDL cholesterol by a median of ∼6.5%. Objectives: We evaluated the effect of a beverage providing 3 g/d high-MW OBG on reduction of LDL cholesterol (primary endpoint) when compared with placebo. Methods: We performed a parallel-design, randomized clinical trial at a contract research organization; participants, caregivers, and outcome assessors were blinded to treatment allocation. Participants with LDL cholesterol between 3.0 and 5.0 mmol/L, inclusive [ n = 538 screened, n = 260 ineligible, n = 23 lost, n = 48 withdrawn (product safety); n = 207 randomly assigned, n = 7 dropped out, n = 9 withdrawn (protocol violation); n = 191 analyzed; n = 72 (37.7%) male, mean ± SD age: 43.3 ± 14.3 y, BMI: 29.7 ± 5.2 kg/m 2 ], were randomly assigned to consume, 3 times daily for 4 wk, 1 g OBG ( n = 104, n = 96 analyzed) or rice powder (Control, n = 103, n = 95 analyzed) mixed into 250 mL water. Treatment effects were assessed as change from baseline and differences analyzed using a 2-sided t test via ANOVA with baseline characteristics as covariates. Results: After 4 wk, change from baseline least-squares-mean LDL cholesterol on OBG (−0.195 mmol/L) was less than on Control (0.012 mmol/L) by mean: 0.207 mmol/L (95% CI: 0.318, 0.096 mmol/L; P = 0.0003); the following secondary endpoints were also reduced as follows: total cholesterol (TC) (0.226 mmol/L; 95% CI: 0.361, 0.091 mmol/L; P = 0.001), TC:HDL cholesterol ratio (0.147; 95% CI: 0.284, 0.010; P = 0.036), non-HDL cholesterol (0.194 mmol/L; 95% CI: 0.314, 0.073 mmol/L; P = 0.002), and Framingham cardiovascular disease (CVD) risk (0.474; 95% CI: 0.900, 0.049, P = 0.029). Changes in HDL cholesterol, triglycerides, glucose, and insulin did not differ between treatment groups ( P > 0.05). Lipid treatment effects were not significantly modified by age, sex, BMI, or hypertension treatment. There were no major adverse events, but both treatments transiently increased gastrointestinal symptoms. Conclusions: Consuming a beverage containing 1 g high-MW OBG 3 times daily for 4 wk significantly reduced LDL cholesterol by ∼6% and CVD risk by ∼8% in healthy adults with LDL cholesterol between 3 and 5 mmol/L. This trial was registered at clinicaltrials.gov as NCT03911427.