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The Impact of Consumption of Eggs in the Context of Plant-Based Diets on Endothelial Function, Diet Quality, and Cardio-Metabolic Risk Factors in Adults at Risk for Type 2 Diabetes

NCT04316429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-08-10

No results posted yet for this study

Summary

Purpose To assess the impact of inclusion of 2 eggs daily for 6 weeks in an otherwise vegan diet compared to a vegan diet on cardio-metabolic risk and dietary pattern in adults at risk for type 2 diabetes.

Hypotheses In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve or have neutral effects on endothelial function and other markers of cardio-metabolic risk in adults at risk for type 2 diabetes.

(2) In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve diet quality and nutrient intake in adults at risk for type 2 diabetes.

(2) In comparison with a vegan diet, the inclusion of 2 eggs daily in an otherwise vegan diet will improve diet quality and nutrient intake in adults at risk for type 2 diabetes.

Conditions

Interventions

OTHER

Egg included vegan phase

: Participants will meet with a registered dietitian and receive instructions to include 2 eggs per day for 6 weeks as part of their otherwise vegan diets. Participants will also receive instructions to preserve an isocaloric condition with the addition of 2 eggs in their diets. Counseling of the study participants will be based on the U.S. Department of Agriculture (USDA) healthy vegetarian meal plans, with modifications to exclude dairy products. \[21\] Additional resources (e.g., educational materials, recipes, etc.) for adopting and maintaining a vegan diet (with the exception of including eggs) will also be provided.

OTHER

Vegan Phase

The participants will consume a vegan diet for 6 weeks. The study dietitian will provide counseling and sample meal plans based on the USDA healthy vegetarian dietary pattern, with modifications to exclude eggs and dairy products. Additional resources (e.g., educational materials, recipes, etc.) for adopting and maintaining a vegan diet will also be provided.

Sponsors & Collaborators

  • Griffin Hospital

    lead OTHER

Principal Investigators

  • Valentine Yanchou Njike, MD, MPH · Yale-Griffin Prevention Reserach Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2020-12-22
Completion
2021-06-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316429 on ClinicalTrials.gov