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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
39
Two eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet.
Non-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses.
Great Lakes Clinical Trials
Chicago, Illinois, United States
Insulin sensitivity index (IV-SI) from short (40 min) IVGTT.
Percent change or change from baseline to end of each treatment condition
Time frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]
Percent change (or change) from baseline to the end of each treatment period.
Time frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Glucose fractional disappearance rate from t = 10-40 min (Kg)
Percent change (or change) from baseline to the end of each treatment period.
Time frame: Up to 40 minutes - measured at baseline and end of each treatment period.
Homeostasis model assessments of insulin sensitivity (HOMA%S)
Percent change (or change) from baseline to the end of each treatment period.
Time frame: Up to 29 days for each treatment period
Beta-cell function (HOMA%B)
Percent change (or change) from baseline to the end of each treatment period.
Time frame: Up to 29 days for each treatment period
Percent change in Total cholesterol (TC)
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)
Time frame: Up to 29 days for each treatment period
Percent change in low-density lipoprotein cholesterol (LDL-C)
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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)
Time frame: Up to 29 days for each treatment period
Percent change in high-density lipoprotein cholesterol (HDL-C)
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)
Time frame: Up to 29 days for each treatment period
Percent change in non-HDL-C
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)
Time frame: Up to 29 days for each treatment period
Percent change in TC/HDL-C ratio
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)
Time frame: Up to 29 days for each treatment period
Percent change in Triglycerides (TG)
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)
Time frame: Up to 29 days for each treatment period
Seated, resting systolic and diastolic blood pressure (BP)
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)
Time frame: Up to 29 days for each treatment period
Vertical Auto-Profile (VAP) analysis of cholesterol carried by lipoproteins and lipoprotein subfractions.
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)
Time frame: Up to 29 days for each treatment period