Status:
COMPLETED
Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.
Lead Sponsor:
Midwest Center for Metabolic and Cardiovascular Research
Conditions:
PreDiabetes
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
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 met...
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 day...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03332927
Start Date
October 25 2017
End Date
August 15 2018
Last Update
July 24 2019
Active Locations (1)
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1
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640