Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method
- Conditions
- Diabetes Mellitus, Type 2Insulin Resistance
- Interventions
- Behavioral: Egg breakfastBehavioral: Egg breakfast with high saturated fatBehavioral: Cereal breakfast with high saturated fatBehavioral: Cereal breakfast
- Registration Number
- NCT03404700
- Lead Sponsor
- Texas Tech University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 48 non-diabetic individuals (fasting glucose < 126 mg/dL)
- Male or female
- BMI from greater or equal to 20 to lesser or equal 60 kg/m2
- Age: 18 - 65 years
- Diabetes
- On antidiabetes medication
- Pregnant or lactating females
- Having a history of gestational diabetes
- Having an unstable cardiac condition
- Having a major systemic illness
- Having a history of drug abuse
- Having a history of eating disorders
- Having uncontrolled hypothyroidism
- Having familial hyperlipidemias
- Having allergies sensitivity to or dislike of eggs
- Consumption of < 1 egg per week
- Attempting to lose weight
- On medications that may influence or inhibit appetite, sensory functioning, or hormone signaling- e.g. antibiotics, anti-depressants, obesity medications. Weight loss > 5% in the past 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 2:Test breakfast A and C Egg breakfast Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order. Group 1:Test breakfast A and B Egg breakfast with high saturated fat \*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. Group 5:Test breakfast B and D Egg breakfast with high saturated fat 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. Group 6:Test breakfast C and D 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 Group 1:Test breakfast A and B Egg breakfast \*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. Group 2:Test breakfast A and C Cereal breakfast Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order. Group 4:Test breakfast B and C Egg 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. Group 3:Test breakfast A and D Egg breakfast Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order. Group 3:Test breakfast A and D Cereal breakfast with high saturated fat Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order. Group 6:Test breakfast C and D Cereal breakfast Subjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order Group 4:Test breakfast B and C Cereal breakfast Subjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast (test breakfast C) in any order. Group 5:Test breakfast B and D Cereal breakfast with high saturated fat 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.
- Primary Outcome Measures
Name Time Method Difference of saturated fat (g) intake in meals containing eggs as compared to meals that do not contain eggs 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.
Difference of energy intake (kcal) in high egg consumers as compared to low egg consumers 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).
Difference of energy intake (kcal) in meals containing eggs as compared to meals that do not contain eggs 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.
Difference of saturated fat (g) intake in high egg consumers as compared to low egg consumers 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).
Difference of blood glucose levels compared between different test breakfasts 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.
Difference of insulin levels compared between different test breakfasts 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.
- Secondary Outcome Measures
Name Time Method Difference of subjective hunger level compared between different test breakfasts 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.
Difference of HbA1c levels in high egg consumers as compared to low egg consumers 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.
Difference of subjective satiety level compared between different test breakfasts 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.
Difference of objective hunger compared between different test breakfasts 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.
Difference of objective satiety compared between different test breakfasts using serum Glucagon-like peptide-1 (GLP-1) levels 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.
Difference in Resting Metabolic Rate (RMR) compared between different test breakfasts 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.
Difference in total energy intake (kcal) compared between Remote Food Photography Method (RFPM), 7-day food record and 24-hour recall 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.
Difference of objective satiety compared between different test breakfasts using serum Peptide YY (PYY 3-36) levels 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.
Difference in Homeostasis Model Assessment-Insulin resistance (HOMA-IR) compared between different test breakfasts 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.
Trial Locations
- Locations (1)
Texas Tech University - Department of Nutritional Sciences
🇺🇸Lubbock, Texas, United States