Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.

Completed · Not applicable

Conditions studied: PreDiabetes

In brief

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.

Key facts

Study ID

NCT03332927

Run by

Midwest Center for Metabolic and Cardiovascular Research

People needed

39

Starts

2017-10-25

Expected to finish

2018-08-15

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI of ≥25.0 kg/m2 (≥23.0 kg/m2 in Asian Americans) to 39.99 kg/m2.
• 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.
• 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.

You may not qualify if…

• 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).
• 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.
• Known allergy, sensitivity, or intolerance to any ingredients in the study foods.
• Uncontrolled hypertension
• Recent history of cancer in the prior 5 years, except for non-melanoma skin cancer.
• Recent change in body weight of ±4.5 kg.
• Unstable use of any antihypertensive medication.
• 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.
• 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
• Use of antibiotics within 5 days of screening.
• 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.
• Extreme dietary habits (e.g., vegan or very low carbohydrate diet).
• Current or recent history or strong potential, for drug or alcohol abuse.
• History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
• Recent exposure to any non-registered drug product.

Where it is running

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

Full record on ClinicalTrials.gov

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