Effect of Egg Consumption on Cardiometabolic Health in Prediabetic Subjects.

NCT03332927 | Completed

• 1 other identifier: MB-1704
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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 metabolic health, including fasting lipoprotein lipid levels and resting blood pressure.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity index (IV-SI) from short (40 min) IVGTT.

  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 Outcomes (12)

• Disposition index [acute insulin response to intravenous glucose (AIRg) x IV-SI]

  Up to 40 minutes - measured at baseline and end of each treatment period.

• Glucose fractional disappearance rate from t = 10-40 min (Kg)

  Up to 40 minutes - measured at baseline and end of each treatment period.

• Homeostasis model assessments of insulin sensitivity (HOMA%S)

  Up to 29 days for each treatment period

• Beta-cell function (HOMA%B)

  Up to 29 days for each treatment period

• Percent change in Total cholesterol (TC)

  Up to 29 days for each treatment period

Study Arms (2)

Egg based breakfast foods

EXPERIMENTAL

Study products delivering two eggs/day, 6 days per week, will be administered for the 4-week treatment period.

Other: Egg based breakfast foods

Non-egg based breakfast foods

ACTIVE COMPARATOR

Study products delivering non-egg based control breakfast foods will be administered 6 days per week for the 4-week treatment period.

Other: Non-egg based breakfast foods

Interventions

Egg based breakfast foods OTHER

Two eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet.

Egg based breakfast foods

Non-egg based breakfast foods OTHER

Non-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses.

Non-egg based breakfast foods

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead

Study Sites (1)

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: October 25, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (1)