Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments egg inclusion, egg exclusion
Sponsor Griffin Hospital
Collaborator American Egg Board
Start date January 2014
End date July 2015
Trial size 40 participants
Trial identifier NCT02052037, 2013-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Experimental)
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.
(Experimental)
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.

Primary Outcomes

Measure
Glycemic Index
time frame: 12-weeks

Secondary Outcomes

Measure
Fasting glucose and insulin
time frame: 12-weeks
Body Composition
time frame: 12- weeks
Body Weight
time frame: 12- weeks
Waist Circumference
time frame: 12-weeks
Diet Quality
time frame: Baseline, 6-weeks, 12-weeks
Physical Activity
time frame: 12-weeks

Eligibility Criteria

Male or female participants at least 35 years old.

Inclusion Criteria: - 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; - 6.5% ≤ HbA1c ≤8.0% (5) BMI between 25 and 40 kg/m². Exclusion Criteria: - failure to meet inclusion criteria; - 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.

Additional Information

Official title Egg Ingestion in Adults With Type 2 Diabetes: Effects on Glycemic Control, Anthropometry, Diet Quality and Cardiometabolic Status A Randomized, Controlled, Crossover Trial
Principal investigator David L. Katz, MPH,MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Griffin Hospital.