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Ensayo controlado aleatorizado2025Financiación no declarada

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

Nouhravesh N, Harrington J, Aberle LH, Green CL, Voss K, Holdsworth D, Misialek K, Slaugh BT, Wieand M, Yancy WS, Pagidipati N, Mentz RJ

American heart journal · 1 cita

Etiquetas de revisión

Financiación no declarada

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación no declarada

Publicación

Publicado
2024-10-15 · Am Heart J · vol. 279 · págs. 27–39
Editorial
Elsevier BV
Citado
2 citas · más que el 65% de estudios similares · 0.5× el promedio de su campo
Referencias
26 trabajos
Acceso
Acceso abierto (revista híbrida) · CC-BY
Áreas de investigación
Dietary Effects on Health · Nutritional Studies and Diet · Lipoproteins and Cardiovascular Health
Palabras clave
time-restricted eating, cardiometabolic health, cardiovascular risk, LDL cholesterol, HDL cholesterol, lipids, inflammatory markers, micronutrients, dietary supplementation, older adults
MeSH
humans, cardiovascular diseases, eggs, food, fortified, aged, middle aged, female, male, cholesterol, ldl, cholesterol, hdl, biomarkers, cardiometabolic risk factors

12 autores

  • Nina Nouhravesh🇺🇸 · autor de correspondenciaDuke University
  • Josephine Harrington🇺🇸Duke University
  • Laura H. Aberle🇺🇸Duke University
  • Cynthia L. Green🇺🇸Duke University; Duke Medical Center
  • Kathleen Voss🇺🇸Duke University; Duke Medical Center
  • Dave Holdsworth
  • Kurt Misialek
  • Bartel T Slaugh
  • Mandee Wieand
  • William S. Yancy🇺🇸Medical University of South Carolina
  • Neha Jadeja Pagidipati🇺🇸Duke University; Duke Medical Center
  • Robert John Mentz🇺🇸Duke University; Duke Medical Center

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Given the increasing interest in dietary interventions to improve cardiovascular health, this trial assessed the impact of fortified eggs (FE) versus nonegg 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 2 cardiovascular risk factors, to FE or a nonegg 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 nonegg 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 (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 nonegg 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]). Prespecified subgroups revealed a nonsignificant 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 nonegg 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.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).

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