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 | Completed

• 1 other identifier: 2019-09
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 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

Type 2 Diabetes; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Endothelial Function (EF) Assessment:

  EF will be assessed at each of the 4 study visits and will be measured noninvasively in the right brachial artery by a high-frequency, 10-15 MHz, vascular ultrasound transducer (Philips iU22, Philips Medical Systems, Bothell, WA) in accordance with published guidelines. Endothelial function will be measured as Flow-mediated dilatation (FMD), that is the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release. In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity. To account for potential variability in stimulus strength, a secondary analysis will be performed in which FMD is divided by flow at 15 seconds post-cuff deflation to create a stimulus-adjusted response measure. All brachial artery reactivity studies (BARS) will be completed prior to noon.

  20 weeks

Secondary Outcomes (8)

• Change in Diet quality: Automated Self-Administered 24-Hour Recall (ASA24)

  20 weeks

• Change in Serum Lipids

  20 weeks

• Change in Body composition

  20 weeks

• Change in Body weight

  20 weeks

• Waist circumference

  20 weeks

Study Arms (2)

Egg phase:

ACTIVE COMPARATOR

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.

Other: Egg included vegan phase

Control phase:

PLACEBO COMPARATOR

The participants will consume a vegan diet for 6 weeks.

Other: Vegan Phase

Interventions

Egg included vegan phase OTHER

: 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.

Egg phase:

Vegan Phase OTHER

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.

Control phase:

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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 %.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Griffin Hospital: lead

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Related Publications (28)

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• Njike VY, Treu JA, Kela GCM, Ayettey RG, Comerford BP, Siddiqui WT. Egg Consumption in the Context of Plant-Based Diets and Cardiometabolic Risk Factors in Adults at Risk of Type 2 Diabetes. J Nutr. 2021 Dec 3;151(12):3651-3660. doi: 10.1093/jn/nxab283.

  PMID: 34494112 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Valentine Yanchou Njike, MD, MPH

  Yale-Griffin Prevention Reserach Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Model Details: To provide a sound basis for the statistical comparison of outcome measures for treatment assignments, participants will be randomized to 1 of 2 sequence permutations of an egg-included vegan diet and a vegan diet, which will begin after a 4-week run in phase. Each permutation will include a 6-week treatment phase, followed by a 4-week washout phase, followed by 6-week treatment phase (20 weeks total for each study participant, including the run-in phase).

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 20, 2020
• Study Start: June 9, 2020
• Primary Completion: December 22, 2020
• Study Completion: June 1, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

US (1)