The Effect of Eggs on Postprandial Metabolism

This study is currently recruiting participants. (see Contacts and Locations)
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

April 27, 2011
September 23, 2013
April 2011
April 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01351207 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
Other: Eggs
Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding
  • Active Comparator: pork sausages and hash brown potatoes plus eggs
    Intervention: Other: Eggs
  • Placebo Comparator: pork sausages and hash brown potatoes plus egg-free pudding
    Intervention: Other: Eggs
  • Placebo Comparator: pork sausages and hash brown potatoes
    Intervention: Other: Eggs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
Yes
Contact: Diane L McKay, PhD 781-608-7183 diane.mckay@tufts.edu
Contact: Jeffrey B Blumberg, PhD 617-556-3334 jeffrey.blumberg@tufts.edu
United States
 
NCT01351207
IRB9795
Not Provided
Tufts University
Tufts University
American Egg Board
Principal Investigator: Diane L. McKay, PhD Tufts Medical Center
Tufts University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP