Egg Ingestion in Adults With Type 2 Diabetes
1 other identifier
interventional
32
1 country
1
Brief Summary
We propose a prospective, randomized, single-blind controlled crossover study to assess the effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric measures, and overall diet quality in adults with Type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Jan 2014
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
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 6, 2017
November 1, 2017
1.8 years
January 29, 2014
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic Index
Glycated hemoglobin A1c (HbA1c) will be used to measure the average plasma glucose concentration.
12-weeks
Secondary Outcomes (6)
Fasting glucose and insulin
12-weeks
Body Composition
12- weeks
Body Weight
12- weeks
Waist Circumference
12-weeks
Diet Quality
Baseline, 6-weeks, 12-weeks
- +1 more secondary outcomes
Study Arms (2)
Egg inclusion
EXPERIMENTALParticipants will meet with a registered dietitian and receive instructions for including 2 eggs per day (10 to 14 eggs/week) in their meal plan, while preserving an isocaloric condition relative to the egg exclusion phase. The study dietitian will provide individualized guidance to participants on how to make room for eggs in their diet, while giving them latitude in determining how to adjust for the extra calories from the eggs, to better approximate real-world conditions.
Egg exclusion
EXPERIMENTALParticipants will meet with the dietitian and receive relevant meal planning guidance and instructions to avoid eggs and specific egg-containing products. During both intervention phases, study participants will be advised to eat to their usual state of fullness, and dietary monitoring and weighing will be conducted to ensure that an isocaloric condition is maintained.
Interventions
Participants will meet with a registered dietitian and receive instructions for including 2 eggs per day (10 to 14 eggs/week)in their meal plan, while preserving an isocaloric condition relative to the egg exclusion phase. The study dietitian will provide individualized guidance to participants on how to make room for eggs in their diet, while giving them latitude in determining how to adjust for the extra calories from the eggs, to better approximate real-world conditions. Treatment phase will last for 12 weeks.
Participants will meet with the dietitian and receive relevant meal planning guidance and instructions to avoid eggs and specific egg-containing products. During both intervention phases, study participants will be advised to eat to their usual state of fullness, and dietary monitoring and weighing will be conducted to ensure that an isocaloric condition is maintained. Treatment phase will last for 12 weeks.
Eligibility Criteria
You may qualify if:
- males age greater than 35 years;
- post-menopausal females not currently on hormone replacement therapy;
- non-smokers;
- clinical diagnosis of Type 2 diabetes mellitus for at least 1 year but no more than 5 years;
- % ≤ HbA1c ≤8.0% (5) BMI between 25 and 40 kg/m².
You may not qualify if:
- anticipated inability to complete study protocol for any reason;
- current eating disorder;
- use of antihyperglycemic, lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months;
- use of glucocorticoids, antineoplastic agents, psychoactive agents, or nutraceuticals;
- regular use of fiber supplements;
- restricted diets (i.e., vegetarian, vegan, gluten free);
- known allergy to eggs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Griffin Hospitallead
- American Egg Boardcollaborator
Study Sites (1)
Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418, United States
Related Publications (2)
Njike VY, Annam R, Costales VC, Yarandi N, Katz DL. Which foods are displaced in the diets of adults with type 2 diabetes with the inclusion of eggs in their diets? A randomized, controlled, crossover trial. BMJ Open Diabetes Res Care. 2017 Jul 13;5(1):e000411. doi: 10.1136/bmjdrc-2017-000411. eCollection 2017.
PMID: 28761662DERIVEDNjike VY, Ayettey RG, Rajebi H, Treu JA, Katz DL. Egg ingestion in adults with type 2 diabetes: effects on glycemic control, anthropometry, and diet quality-a randomized, controlled, crossover trial. BMJ Open Diabetes Res Care. 2016 Dec 22;4(1):e000281. doi: 10.1136/bmjdrc-2016-000281. eCollection 2016.
PMID: 28074139DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David L. Katz, MPH,MD
Yale-Griffin Prevention Research Center
- PRINCIPAL INVESTIGATOR
Valentine Y. Njike, MPH,MD
Yale-Griffin Prevention Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
January 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
November 6, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share