Effects of fortified eggs and time-restricted eating on cardiometabolic health: The PROSPERITY trial

Nina Nouhravesh; Josephine Harrington; Laura H Aberle; Cynthia L Green; Kathleen Voss; Dave Holdsworth; Kurt Misialek; Bartel T Slaugh; Mandee Wieand; William S Yancy Jr; Neha Pagidipati; Robert J Mentz

doi:10.1016/j.ahj.2024.10.005

Effects of fortified eggs and time-restricted eating on cardiometabolic health: The PROSPERITY trial

Am Heart J. 2024 Oct 14:S0002-8703(24)00267-9. doi: 10.1016/j.ahj.2024.10.005. Online ahead of print.

Authors

Affiliations

¹ Duke Clinical Research Institute, Durham, NC, USA. Electronic address: nina.nouhravesh@duke.edu.
² Duke Clinical Research Institute, Durham, NC, USA.
³ Duke Clinical Research Institute, Durham, NC, USA; Duke University School of Medicine, Durham, NC, USA.
⁴ Duke University School of Medicine, Durham, NC, USA.
⁵ Eggland's Best, LLC, Malvern, PA, USA.
⁶ Medical University of South Carolina Health Cardiology, Charleston, SC, USA.

PMID: 39414223
DOI: 10.1016/j.ahj.2024.10.005

Abstract

Background: Given 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.

Methods: The 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.

Results: Overall, 140 patients were randomized with median (25^th, 75^th 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.

Conclusions: These 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 registration: ClinicalTrials.gov Identifier: NCT04673721.

Keywords: Dietary intervention; Eggs; biomarkers; cholesterol; time-restricted eating.

Associated data

ClinicalTrials.gov/NCT04673721