Clinical trial NCT02052037: Egg Ingestion in Adults With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Egg
Glycemic Control
Insulin sensitivity
Diet quality
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2014-01-31
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic Index
timeFrame: 12-weeks
Secondary outcomes:
measure: Fasting glucose and insulin
timeFrame: 12-weeks
measure: Body Composition
timeFrame: 12- weeks
measure: Body Weight
timeFrame: 12- weeks
measure: Waist Circumference
timeFrame: 12-weeks
measure: Diet Quality
timeFrame: Baseline, 6-weeks, 12-weeks
measure: Physical Activity
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Derby
country: United States
facility: Yale-Griffin Prevention Research Center
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: David L. Katz, MPH,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale-Griffin Prevention Research Center
name: Valentine Y. Njike, MPH,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.