BackgroundGiven the increasing interest in dietary interventions to improve cardiovascular health, this trial assessed the impact of fortified eggs (FE) versus non-egg supplemented diet and time-restricted eating (TRE) versus usual care diet on cardiovascular biomarkers. MethodsThe study was a unblinded, 2-by-2 factorial design, which randomized patients, with either a prior cardiovascular event or two cardiovascular risk factors, to FE or a non-egg supplemented diet and TRE or usual care diet. Patients randomized to FE were instructed to consume at least 12 FE/week (with eggs provided); those on a non-egg supplemented diet restricted egg consumption to <2 eggs/week. TRE participants were instructed to consume all calories within an 8-hour window daily and fasted for the remaining 16 hours. Patients randomized to usual diet were advised to maintain current dietary habits. Follow-up was performed in-person at 1 and 4 months, and telephone calls at 2 and 3 months. Co-primary endpoints were 4-month LDL- and HDL-cholesterol. Secondary endpoints included additional lipids, cardiometabolic- and inflammatory biomarkers and micronutrient levels at 4-months. ResultsOverall, 140 patients were randomized with median (25th, 75th percentiles) age 66 (58, 73) years; 72 (51%) women, 38 (27%) Black, and 33 (24%) with diabetes mellitus. The difference in least squares (LS) means from baseline to 4-months for HDL and LDL levels revealed no significant clinical difference between FE vs. non-egg supplemented diet (HDL: -0.64 mg/dL [95% CI: -3.86, 2.58]; LDL: -3.14 mg/dL [-10.81, 4.52]) and TRE vs. usual care diet (HDL: 1.51 mg/dL [-1.65, 4.68]; LDL 1.17 mg/dL [-6.36, 8.70]). Pre-specified subgroups revealed a non-significant HDL increase and LDL decrease with FE in patients ≥65 years. ConclusionsThese data did not demonstrate clinically relevant differences in changes in LDL and HDL levels over 4 months with FE and TRE compared with non-egg supplemented diet and usual care diet, respectively, providing evidence that adverse short-term lipid and biomarker changes did not occur with FE consumption. Trial RegistrationClinicalTrials.gov Identifier: NCT04673721.
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