Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects. (NCT03332927) | Clinical Trial Compass
CompletedNot Applicable
Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.
United States39 participantsStarted 2017-10-25
Plain-language 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 metabolic health, including fasting lipoprotein lipid levels and resting blood pressure.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Atherosclerotic cardiovascular disease including any of the following:
✕. 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.
What they're measuring
1
Insulin sensitivity index (IV-SI) from short (40 min) IVGTT.
Timeframe: Up to 40 minutes - measured at baseline and end of each treatment period.
Trial details
NCT IDNCT03332927
SponsorMidwest Center for Metabolic and Cardiovascular Research