Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409, United States
NCT Number: NCT03404700
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lubbock, Texas, 79409, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 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
Other names: 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
Other names: 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
Other names: Breakfast D
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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
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
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
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: 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)
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)
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)
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)
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)
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)
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)
This will be measured on visit 1 and 2 after providing test breakfasts by measuring serum PYY 3-36 levels.
Time frame: Changes in blood concentration (arbitrary units AU) on visit 1 (Part II of the study)
This will be measured by taking blood on the visit 1.
Time frame: Changes in HOMA-IR values (arbitrary units AU) on visit 1 and 2 after providing test breakfasts (Part II of the study)
This will be calculated using blood glucose and insulin levels.
Time frame: Changes in RMR (kcal/24hrs) on visit 1 and 2 following each test breakfast ( Part II of the study)
RMR will be assessed following different test breakfasts on visit 1 and 2.
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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.
Texas Tech University
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