The Effect of Eggs on Postprandial Metabolism

Study Overview
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Brief Summary
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The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism when included with other cooked breakfast foods typically selected by older Americans.

Official Title
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The Effect of Eggs on Postprandial Metabolism: A Randomized, Controlled Crossover Pilot Study in Older, Overweight Adults

Conditions
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Healthy

Intervention / Treatment
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* Other: Eggs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men & postmenopausal women, aged 50-70 years BMI 28-34 kg/m2 Exclusion Criteria: Cigarette smoking and/or nicotine replacement use Individuals taking estrogen Use of cholesterol-lowering medications Use of blood pressure-lowering medications Regular use of any stomach acid-lowering medications or laxatives (including fiber supplements) Cardiovascular (heart) disease Gastrointestinal disease Kidney disease Endocrine disease: including diabetes, untreated thyroid disease Rheumatoid arthritis Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg Regular use of oral steroids Regular daily intake of ≥ 2 alcoholic drinks Vegetarians Allergy to eggs Avoidance and/or intolerance of pork products No dietary supplements, including those containing any vitamins, minerals,herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pork sausages and hash brown potatoes plus eggs<br> | Other: Eggs<br>* Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding<br>|
| Placebo Comparator: pork sausages and hash brown potatoes plus egg-free pudding<br> | Other: Eggs<br>* Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding<br>|
| Placebo Comparator: pork sausages and hash brown potatoes<br> | Other: Eggs<br>* Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial change in blood glucose concentration compared to placebo | Biomarkers of glucoregulation and insulin sensitivity, inflammation, lipid peroxidation, antioxidant activity, and satiety hormone production will be assessed in blood and urine | 0-4 h |