Status:
COMPLETED
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
Lead Sponsor:
Griffin Hospital
Conditions:
Type 2 Diabetes
Cardiovascular Diseases
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief 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 diab...
Detailed Description
Specific Aims of the Proposed Project: 1. To assess the impact of inclusion of 2 eggs daily for 6 weeks in an otherwise vegan diet, compared to a vegan diet, on endothelial function in adults at risk...
Eligibility Criteria
Inclusion
- 1\) Male, 25-75 years or postmenopausal female 2) Non-smoker; 3) At risk for T2DM as defined by meeting at least one of the criteria listed:
- Metabolic syndrome, i.e. meet three out of five of the following criteria:
- blood pressure \>130/85 mmHg or currently taking antihypertensive medication;
- fasting plasma glucose (FPG) \>100 mg/dL (6.1 mmol/L);
- serum triglycerides level (TG)\>150 mg/dL (1.69 mmol/L);
- high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1.04 mmol/L) in men, and \< 50 mg/dL (1.29 mmol/L) in women;
- overweight (BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women.
- Fasting blood glucose \>100mg/dL and \<126mg/dL or hemoglobin A1C 5.7-6.4 %.
Exclusion
- 1\) Allergy to eggs; 2) Anticipated inability to complete the study protocol for any reason; 3) Current eating disorder; 4) Unstable use of lipid-lowering or antihypertensive medications (i.e., change in dose during the three months prior to enrollment) and/or unwilling to refrain from taking medication for 12 hours prior to endothelial function scanning; 5) Regular use of high doses of vitamin E (\>400IU/day) or vitamin C (\>500mg/day); fish oil, flaxseed oil, omega-3 fatty acid and/or fiber supplement, unless willing to discontinue supplementation for the study duration; 6) Use of insulin, glucose-sensitizing medication, or vasoactive medication (including glucocorticoids, antineoplastic agents, some psychoactive agents, or bronchodilators); 7) Unstable use of antidepressant medications (i.e., change in dose during the three months prior to enrollment; 8) Diagnosed diabetes; 9) Diagnosed sleep apnea; unless treated and have been stable with their medications for at least 3 months 10) Established cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, peripheral vascular disease, congestive heart failure, carotid stenosis); 11) Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin or other regular use of anticoagulation; 12) Substance abuse (chronic alcoholism, other chemical dependency); 13) Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder); 14) For women: Use of hormone replacement therapy
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04316429
Start Date
June 9 2020
End Date
June 1 2021
Last Update
August 10 2021
Active Locations (1)
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1
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418