NCT02052037

Egg Ingestion in Adults With Type 2 Diabetes

Egg Ingestion in Adults With Type 2 Diabetes: Effects on Glycemic Control, Anthropometry, Diet Quality and Cardiometabolic Status A Randomized, Controlled, Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Griffin Hospital · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesis Inclusion of eggs in the diets of individuals with Type 2 diabetes mellitus will improve glycemic control, anthropometric measures and overall diet quality. 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

• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-01-31
• Last updated: 2017-11-06

Locations

1 site across 1 country: United States