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The Effect of Eggs on Postprandial Metabolism

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ClinicalTrials.gov Identifier: NCT01351207
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Tufts University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Eggs Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Eggs on Postprandial Metabolism: A Randomized, Controlled Crossover Pilot Study in Older, Overweight Adults
Study Start Date : April 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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



Primary Outcome Measures :
  1. Postprandial change in blood glucose concentration compared to placebo [ Time Frame: 0-4 h ]
    Biomarkers of glucoregulation and insulin sensitivity, inflammation, lipid peroxidation, antioxidant activity, and satiety hormone production will be assessed in blood and urine



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351207


Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
American Egg Board
Investigators
Principal Investigator: Diane L. McKay, PhD Tufts Medical Center

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01351207     History of Changes
Other Study ID Numbers: IRB9795
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014