The Effect of Eggs on Postprandial Metabolism

This study is currently recruiting participants.
Verified September 2013 by Tufts University
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT01351207
First received: April 27, 2011
Last updated: September 23, 2013
Last verified: September 2013
  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


Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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

Contacts
Contact: Diane L McKay, PhD 781-608-7183 diane.mckay@tufts.edu
Contact: Jeffrey B Blumberg, PhD 617-556-3334 jeffrey.blumberg@tufts.edu

Locations
United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Diane L. McKay, PhD         
Sub-Investigator: Jeffrey B. Blumberg, PhD         
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: September 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 22, 2014