Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.

A Randomized, Crossover Trial to Assess the Effects of Replacing Commonly Consumed Breakfast Foods With Eggs on Insulin Sensitivity and Other Markers of Cardiometabolic Health in Men and Women at Increased Risk for Type 2 Diabetes Mellitus.

The objective of this trial is to assess the effects of whole egg consumption (12 per week), compared to energy-matched typical breakfast control foods, on insulin sensitivity and other markers of metabolic health, including fasting lipoprotein lipid levels and resting blood pressure.

Study Overview

Detailed Description

This is a randomized, crossover study that includes two screening visits and two 4-week test periods separated by a 4-week washout. Subjects will consume two eggs/day (12 eggs/week consumed over 6 days per week, provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet) or non-egg based control foods (provided as breakfast foods such as English muffins, bagels, ready-to-eat cereal, and flavored muffins). The background diet will be a habitual diet. The nutritional profiles of the egg and control breakfast foods will be designed such that the energy from eggs will be substituted for a mixture of carbohydrate, protein and fat in the control foods.

Study foods will be dispensed with instructions to consume the assigned breakfast food starting on day 1. Subjects will be instructed to consume the breakfast foods in their entirety each day, for the duration of the 28 day test period, and to record daily study food intake. Subjects will receive diet instruction on the incorporation of food substitutions during the test period to maintain habitual energy intake. Compliance will be assessed using the Daily Log intake and number of foods consumed based on returned foods.

An intravenous glucose tolerance test (IVGTT) will be completed at baseline and the end of each treatment period for evaluation of insulin sensitivity. Blood will be collected for a fasting lipid profile (at all visits), glucose and insulin, high-sensitivity C-reactive protein (hs-CRP), vertical auto profile (VAP) for cholesterol carried by lipoprotein fractions (at baseline and end of each treatment period), with additional blood samples collected for storage and archived for possible future analysis of non-genetic indicators of metabolism. Assessments of vital signs and body weight, review of concomitant medication/supplement use and inclusion and exclusion criteria for relevant changes, and evaluation of adverse effects will be performed throughout the study.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. BMI of ≥25.0 kg/m2 (≥23.0 kg/m2 in Asian Americans) to 39.99 kg/m2.
  2. Metabolic syndrome [exhibiting at least 3 out of 5 of these criteria]: waist circumference ≥102 cm (40 inches) in men or ≥88 cm (35 inches) in women, TG level ≥150 mg/dL, HDL-C level <40 mg/dL in men or <50 mg/dL in women, hypertension: ≥130 systolic and/or /≥85 diastolic or on drug therapy for elevated BP, fasting hyperglycemia: 100-125 mg/dL.
  3. Prediabetes [exhibiting any of the criteria below at screening]: glycated hemoglobin 5.7-6.4% (inclusive), or fasting capillary glucose of 100-125 mg/dL (inclusive), or a 2-h postprandial glucose of 140-199 mg/dL.

Exclusion Criteria:

  1. Atherosclerotic cardiovascular disease including any of the following:

    clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound] or other forms of clinical atherosclerotic disease (e.g., renal artery disease).

  2. History or presence of clinically important pulmonary (including uncontrolled asthma), endocrine (including type 1 or 2 diabetes mellitus), chronic inflammatory disease (including irritable bowel disease, lupus, rheumatoid arthritis), hepatic, renal, hematologic, immunologic, neurologic, or biliary disorders.
  3. Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
  4. Uncontrolled hypertension
  5. Recent history of cancer in the prior 5 years, except for non-melanoma skin cancer.
  6. Recent change in body weight of ±4.5 kg.
  7. Unstable use of any antihypertensive medication.
  8. Recent use of any medications intended to alter the lipid profile [e.g. bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin (drug form), omega-3-ethyl ester drugs, and/or proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors], weight-loss drugs, systemic corticosteroid drugs, medications known to influence carbohydrate (CHO) metabolism [e.g. adrenergic receptor blockers, thiazide diuretics, hypoglycemic medications], and/or anti-psychotics.
  9. Recent use of foods or dietary supplements that might influence lipid metabolism [e.g. omega-3 fatty acid supplements (e.g., fish or algal oils) or fortified foods, sterol/stanol products; dietary supplements (red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d], inconsistent use of Metamucil® or viscous fiber-containing supplements
  10. Use of antibiotics within 5 days of screening.
  11. Pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  12. Extreme dietary habits (e.g., vegan or very low carbohydrate diet).
  13. Current or recent history or strong potential, for drug or alcohol abuse.
  14. History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
  15. Recent exposure to any non-registered drug product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egg based breakfast foods
Study products delivering two eggs/day, 6 days per week, will be administered for the 4-week treatment period.
Two eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet.
Active Comparator: Non-egg based breakfast foods
Study products delivering non-egg based control breakfast foods will be administered 6 days per week for the 4-week treatment period.
Non-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity index (IV-SI) from short (40 min) IVGTT.
Time Frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Percent change or change from baseline to end of each treatment condition
Up to 40 minutes - measured at baseline and end of each treatment period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]
Time Frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Percent change (or change) from baseline to the end of each treatment period.
Up to 40 minutes - measured at baseline and end of each treatment period.
Glucose fractional disappearance rate from t = 10-40 min (Kg)
Time Frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Percent change (or change) from baseline to the end of each treatment period.
Up to 40 minutes - measured at baseline and end of each treatment period.
Homeostasis model assessments of insulin sensitivity (HOMA%S)
Time Frame: Up to 29 days for each treatment period
Percent change (or change) from baseline to the end of each treatment period.
Up to 29 days for each treatment period
Beta-cell function (HOMA%B)
Time Frame: Up to 29 days for each treatment period
Percent change (or change) from baseline to the end of each treatment period.
Up to 29 days for each treatment period
Percent change in Total cholesterol (TC)
Time Frame: Up to 29 days for each treatment period
Percent change in TC from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Percent change in low-density lipoprotein cholesterol (LDL-C)
Time Frame: Up to 29 days for each treatment period
Percent change in LDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Percent change in high-density lipoprotein cholesterol (HDL-C)
Time Frame: Up to 29 days for each treatment period
Percent change in HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Percent change in non-HDL-C
Time Frame: Up to 29 days for each treatment period
Percent change in non-HDL-C from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Percent change in TC/HDL-C ratio
Time Frame: Up to 29 days for each treatment period
Percent change in TC/HDL-C ratio from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Percent change in Triglycerides (TG)
Time Frame: Up to 29 days for each treatment period
Percent change in TG from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Seated, resting systolic and diastolic blood pressure (BP)
Time Frame: Up to 29 days for each treatment period
Percent change in seated, resting systolic and diastolic BP (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period
Vertical Auto-Profile (VAP) analysis of cholesterol carried by lipoproteins and lipoprotein subfractions.
Time Frame: Up to 29 days for each treatment period
Percent change in VAP analysed cholesterol in lipoproteins and lipoprotein subfractions from baseline (average of the values from one screening visit and the baseline visit) to the end of each test condition (average of the values at 3-week and 4-week visits of each test period)
Up to 29 days for each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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