Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2014-01-31
2015-11-30
Brief Summary
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Detailed Description
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Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients at increased risk for CVD, including those with diabetes. However, the relative importance of dietary cholesterol to serum lipids and the role of egg ingestion in cardiovascular risk are increasingly suspect. Further, the exclusion of eggs from the diet may lead to increased consumption of high-glycemic carbohydrate foods of particular potential harm to individuals with diabetes. The examination of how food-specific recommendations translate into effects on other food choices and overall diet quality, and in turn health effects, is a neglected area of research.
Eggs provide a complete profile of amino acids and an array of micronutrients, and are low in total fat. Although epidemiological and clinical studies largely suggest a lack of association between egg intake and harmful effects, the evidence is somewhat more ambiguous with regard to glycemic control for diabetes, or the risk for CVD among individuals with diabetes. Our own prior work shows no adverse effects of egg ingestion in healthy adults, hyperlipidemic adults, or adults with established coronary artery disease. As a satiating and protein-rich food, eggs have potential to foster calorie and weight control, and to reduce the dietary glycemic load, offering potential advantages in Type 2 diabetes.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Egg inclusion
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.
Egg inclusion
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.
Egg exclusion
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.
Egg exclusion
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.
Interventions
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Egg inclusion
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.
Egg exclusion
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
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Inclusion Criteria
* 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;
* 6.5% ≤ HbA1c ≤8.0% (5) BMI between 25 and 40 kg/m².
* 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.
35 Years
ALL
No
Sponsors
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American Egg Board
OTHER
Griffin Hospital
OTHER
Responsible Party
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Principal Investigators
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David L. Katz, MPH,MD
Role: PRINCIPAL_INVESTIGATOR
Yale-Griffin Prevention Research Center
Valentine Y. Njike, MPH,MD
Role: PRINCIPAL_INVESTIGATOR
Yale-Griffin Prevention Research Center
Locations
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Yale-Griffin Prevention Research Center
Derby, Connecticut, United States
Countries
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References
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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.
Njike 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.
Other Identifiers
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2013-05
Identifier Type: -
Identifier Source: org_study_id