An interventional study of Egg breakfast and Egg breakfast with high saturated fat in Diabetes Mellitus, Type 2 and Insulin Resistance, sponsored by Texas Tech University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Texas Tech University · Not applicable, Interventional, and Other
Recent epidemiological studies show that egg consumption is associated with insulin resistance and altered glycemic control. For this study, the investigators hypothesize that this association is due to dietary patterns associated with egg consumption, such as saturated fat, and not the consumption of eggs per se. This study will be conducted in two parts that will be conducted simultaneously. Part I will utilize an ecological momentary assessment approach in which dietary patterns associated with egg intake will be determined using an objective measurement of food intake called remote food photography method. In Part II, a randomized partial crossover study will be conducted on the same sample of subjects to test the effects of egg consumption, saturated fat consumption, and consumption of the combination of eggs and saturated fat on glucose, insulin, and hunger and satiety hormone levels.
Eggs are nutrient dense, convenient, affordable, and provide key macro and micronutrients in one's diet. Despite having a lot of benefits of consuming eggs in relation to health recent epidemiological studies raise health concerns about egg intake for subgroups of people. For instance, under free-living conditions, higher egg intake is associated with increased cardiovascular disease (CVD) risk in diabetic individuals as well as increased risk of developing type 2 diabetes. However, these studies do not establish that egg consumption "causes" health issues.
It is also possible that the association of egg intake with increased CVD risk in diabetics, or with a greater risk of developing diabetes, is simply due to the other foods that people usually eat with eggs, such as saturated fats, and not due to eggs per se.
For part I, the investigators propose to test this hypothesis by determining the food intake of 48 non-diabetic individuals under free-living conditions using the remote food photography method (RFPM), which uses smartphone technology. The frequency of egg consumption will be obtained using a food frequency questionnaire (FFQ). In addition, participants will record their food intake using food record diary and a 24-hour food recall method. Energy intake information gathered from RFPM will be compared with the 7-day food record and the 24-hour recall.
Next, for part II, the same study participants will be offered four separate test breakfasts of similar calories, containing 1) Eggs; 2) Eggs with a high amount of saturated fat; 3) Cereal breakfast (neither eggs nor saturated fat); or 4) Cereal breakfast with a high amount of saturated fat. Alteration of blood glucose, insulin, hunger, and satiety hormones (ghrelin, PYY, GLP-1), and metabolic rate will be measured before and after each breakfast in part II.
The investigators expect to determine if the purported association of eggs to alterations in glucose control and related metabolic alterations are independent of eggs, but mainly due to saturated fat is eaten along with eggs rather than the egg consumption itself.
Exclusion Criteria:
\*Please note: Part I of the study does not have separate groups. All subjects will undergo RFPM. The description of groups presented below is for part II of the study. Subjects will have egg breakfast(test breakfast A) and egg breakfast with high saturated fat (test breakfast B) in any order.
Behavioral: Egg breakfast · Behavioral: Egg breakfast with high saturated fat
Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order.
Behavioral: Egg breakfast · Behavioral: Cereal breakfast
Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order.
Behavioral: Egg breakfast · Behavioral: Cereal breakfast with high saturated fat
Subjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast (test breakfast C) in any order.
Behavioral: Egg breakfast with high saturated fat · Behavioral: Cereal breakfast
Subjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast with high saturated fat (test breakfast D) in any order.
Behavioral: Egg breakfast with high saturated fat · Behavioral: Cereal breakfast with high saturated fat
Subjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order
Behavioral: Cereal breakfast · Behavioral: Cereal breakfast with high saturated fat
Containing:2 Scrambled Eggs, 120 mL Skim Milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 30g Margarine, 18g Smuckers Strawberry Jam 10 g of Margarine, 18 g of Smuckers® Strawberry Jam
Also known as: Breakfast A
Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam
Also known as: Breakfast B
Containing: 1c Special K ready-to-eat (RTE) High Protein Cereal, 200 mL Silk Original Soy milk, 1 Slice Mrs. Bairds Extra Thin Bread, 35g Margarine, 10 g Smuckers Sugar Free Strawberry Jam
Also known as: Breakfast C
Containing: 1c Special K ready-to-eat (RTE) High Protein Cereal, 200 mL Silk Original Soy milk, 1/2 Slice Arnold Double Protein Whole Grain Bread, 15 g Butter
Also known as: Breakfast D
Difference of energy intake (kcal) in meals containing eggs as compared to meals that do not contain eggs
Energy intake will be determined using Remote Food Photography Method (RFPM) and the meals of all test subjects will be categorized based on the presence or the absence of eggs in the meals.
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
Difference of energy intake (kcal) in high egg consumers as compared to low egg consumers
Comparison of mean daily energy intake as measured by Remote Food Photography Method (RFPM) between high egg consumers and low egg consumers identified by providing a food frequency questionnaire (FFQ).
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
Difference of saturated fat (g) intake in meals containing eggs as compared to meals that do not contain eggs
Saturated fat intake will be determined using Remote Food Photography Method (RFPM) and the meals of all test subjects will be categorized based on the presence or the absence of eggs in the meals.
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
Difference of saturated fat (g) intake in high egg consumers as compared to low egg consumers
Comparison of saturated fat intake as measured by Remote Food Photography Method (RFPM) between high egg consumers and low egg consumers identified by providing a food frequency questionnaire (FFQ).
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
Difference of blood glucose levels compared between different test breakfasts
This will be measured on visit 1 and 2 after providing test breakfasts.
Time frame: Changes in concentration (area under the curve; AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of insulin levels compared between different test breakfasts
This will be measured on visit 1 and 2 after providing test breakfasts.
Time frame: Changes in concentration (area under the curve; AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of subjective hunger level compared between different test breakfasts
This will be measured on visit 1 and 2 after providing test breakfasts.
Time frame: Changes in scores (arbitrary units AU) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of subjective satiety level compared between different test breakfasts
This will be measured on visit 1 and 2 after providing test breakfasts.
Time frame: Changes in scores (arbitrary units AU) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of objective hunger compared between different test breakfasts
This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum ghrelin levels.
Time frame: Changes in concentration (area under the curve AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of objective satiety compared between different test breakfasts using serum Glucagon-like peptide-1 (GLP-1) levels
This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum GLP-1 levels.
Time frame: Changes in concentration (area under the curve AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of objective satiety compared between different test breakfasts using serum Peptide YY (PYY 3-36) levels
This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum PYY 3-36 levels.
Time frame: Changes in concentration (area under the curve AUC) from 30 minutes prior to breakfast to 180 minutes after consumption of test breakfasts (Part II of the study)
Difference of HbA1c levels in high egg consumers as compared to low egg consumers
This will be measured by taking blood on the visit 1.
Time frame: Changes in blood concentration (arbitrary units AU) on visit 1 (Part II of the study)
Difference in Homeostasis Model Assessment-Insulin resistance (HOMA-IR) compared between different test breakfasts
This will be calculated using blood glucose and insulin levels.
Time frame: Changes in HOMA-IR values (arbitrary units AU) on visit 1 and 2 after providing test breakfasts (Part II of the study)
Difference in Resting Metabolic Rate (RMR) compared between different test breakfasts
RMR will be assessed following different test breakfasts on visit 1 and 2.
Time frame: Changes in RMR (kcal/24hrs) on visit 1 and 2 following each test breakfast ( Part II of the study)
Difference in total energy intake (kcal) compared between Remote Food Photography Method (RFPM), 7-day food record and 24-hour recall
Comparison of mean energy intake as determined by RFPM with mean energy intake determined by 7-day food record and a single 24-hour recall.
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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