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The Effect of Eggs on Postprandial Metabolism

This study has been completed.
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01351207
First received: April 27, 2011
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Healthy
 Other: Eggs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Eggs on Postprandial Metabolism: A Randomized, Controlled Crossover Pilot Study in Older, Overweight Adults

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Postprandial change in blood glucose concentration compared to placebo [ Time Frame: 0-4 h ] [ Designated as safety issue: No ]
    Biomarkers of glucoregulation and insulin sensitivity, inflammation, lipid peroxidation, antioxidant activity, and satiety hormone production will be assessed in blood and urine


Enrollment: 7
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01351207     History of Changes
Other Study ID Numbers: IRB9795
Study First Received: April 27, 2011
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013