The Effect of Eggs on Postprandial Metabolism
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Apr 2011
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 19, 2014
November 1, 2014
3.3 years
April 27, 2011
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
pork sausages and hash brown potatoes plus eggs
ACTIVE COMPARATORpork sausages and hash brown potatoes plus egg-free pudding
PLACEBO COMPARATORpork sausages and hash brown potatoes
PLACEBO COMPARATORInterventions
Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding
Eligibility Criteria
You may qualify if:
- Men \& postmenopausal women, aged 50-70 years
- BMI 28-34 kg/m2
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- American Egg Boardcollaborator
Study Sites (1)
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diane L. McKay, PhD
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
May 10, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 19, 2014
Record last verified: 2014-11