The aim of the trial is to examine the impact of high protein intake (from eggs) with calorie restriction on weight loss and insulin resistance in patients with prediabetes. The main outcomes to be measured will be weight loss and blood glucose and insulin levels. This study is being conducted in the United States, North Carolina.
The details
Insulin is a hormone in the body that controls blood glucose. Diabetes is when the body either produces too little insulin or when the body’s cells cannot use insulin effectively (insulin resistance). This results in high levels of sugar in the blood. People with prediabetes have some insulin resistance. When this insulin resistance reaches a certain point, it becomes type 2 diabetes. A healthy diet, exercise and weight loss can prevent patients with prediabetes from developing type 2 diabetes.
The purpose of this study is to see if combining high protein intake (from eggs) with a low-calorie diet can improve weight loss and insulin resistance in patients with prediabetes. Weight loss will be measured by a scales and insulin resistance will be measured by blood glucose and blood insulin levels.
Who are they looking for?
This study will include 40 patients with obesity. Patients must have a high fasting blood sugar (at least 95 mg/dL and lower than 126 mg/dL) and must have a normal kidney function for their age (at least 45 mL/min/1.73 m2). They must also be able to understand spoken and written English.
Patients will be excluded if their body weight is greater than 224 kg or if they have had any weight loss or gain of greater than 10-pounds in the past 6 months. Patients must not have a prior diagnosis of diabetes or an unstable, currently symptomatic or life-limiting illness. Patients must not have any neurological condition that affects reasoning. Patients must not have an allergy or intolerance to eggs and must not be taking monoamine oxidase inhibitors, anti-diabetic or prescription weight loss medications. Patients may not participate if their Primary Care Physician advises against it.
How will it work
Patients will be randomly assigned to either a high protein weight loss intervention group or a regular weight-loss intervention group. The weight loss intervention group will follow a calorie-reduced diet. The high protein weight loss group will follow a calorie-reduced diet with a high proportion of protein from eggs (3 hard boiled eggs per day and egg white protein powder).
The main outcomes to be measured at 4 months will be weight loss with the help of trial scales and insulin resistance through blood glucose and blood insulin levels.
