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Title: Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Endothelial Function, Cardio-Metabolic Risk Factors and Diet Quality
Status: Current
Topic: Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet
Funding Source: The Egg Nutrition Center
Funding Period: July 2022 – December 2023
Study Design: Randomized controlled trial with a crossover design. All participants will be assigned to both an intervention and a control phase. The sequence of the phases will be randomly assigned.
Purpose:

This study will examine the effects of including eggs in the context of the Dietary Approach to Stop Hypertension (DASH) diet.

The DASH diet features vegetables, fruits, whole grains, low-fat dairy products, fish, poultry, beans, nuts, seeds, and vegetable oils. It includes eggs, but limits egg yolks to 4 per week due to their cholesterol content, and the long-standing belief that foods high in dietary cholesterol raise blood cholesterol level. Yet recent studies haven’t supported a link between dietary and blood cholesterol levels and cardiovascular risk.

Because eggs are rich in protein, vitamins, and minerals, and contribute to satiety, it is important to study their consumption in the context of health-promoting diets. 

Further Study Details:

This study will examine the effects of a DASH diet with and without eggs on cardio-metabolic risk measures and diet quality when consumed by 45 overweight adults with high blood cholesterol.  Participants will be randomly assigned to Group A or B. Both groups will receive dietary guidance from the study dietitian.

  • During an initial 4-week run-in period, both groups will consume a DASH diet without eggs.
  • After the first 4 weeks:
    • Group A will consume a DASH diet plus 2 eggs daily for 8 weeks (Phase 1), then a DASH diet without eggs during an 8-week washout, then a DASH diet without eggs for 8 weeks (Phase 2).
    • Group B will consume a DASH diet without eggs for 8 weeks (Phase 1), then a DASH diet without eggs during an 8-week washout, then a DASH diet plus 2 eggs daily for 8-weeks (Phase 2). 
Eligibility:

Inclusion criteria:

  1. Men greater than 18 years of age
  2. Post-menopausal women not on hormone replacement therapy
  3. Non-smokers
  4. Overweight or obese
  5. Total cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of >5.7
Evaluation: Assessments will be done at the start and end of each phase. Each of the 4 study assessments will include these measures: 1. Ultrasound of the brachial artery in the right arm to assess blood flow (endothelial function) 2. Review of 3-day diet intake, medications, and physical activity 3. Blood pressure 4. Height, weight, body composition and waist circumference 5. Blood cholesterol, glucose, and insulin

Changed at: 4/12/2023 4:14 PM Changed by: Christian Meagher
Created at: 4/12/2023 4:14 PM Created by: Christian Meagher

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