The Effect of Eggs on Postprandial Metabolism

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Eggs

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: American Egg Board
• Investigators: Principal Investigator: Diane L. McKay, PhD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimate): May 10, 2011

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: IRB9795