Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method

Conditions
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Diabetes Mellitus, Type 2, Insulin Resistance

Intervention / Treatment
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* Behavioral: Egg breakfast
* Behavioral: Egg breakfast with high saturated fat
* Behavioral: Cereal breakfast
* Behavioral: Cereal breakfast with high saturated fat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The proposed study will comprise of two parts: Part I: an observational study based on ecological momentary assessment, and Part II: a randomized partial crossover clinical trial. Same subjects will participate in both parts of the study. In the observational study, the dietary intake of the subjects will be evaluated using an ecological momentary assessment approach for 7 days. In the randomized partial crossover clinical trial, four test breakfasts will be administered so that each subject will get exposed to only two out of the four diets (thus, partial crossover). Therefore, there will be six possible combinations of diets (i.e. 4! / 2! [4-2]!) and 12 possible ordered combinations (i.e. permutations; 4! / [4-2]!) of diets. Four subjects will be randomly assigned to each of these 12 possible ordered combinations of diets. Thus, the total sample size will be 48 (i.e. n = 4x12).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1:Test breakfast A and B<br>*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<br>* 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<br>* Other names: Breakfast A;Behavioral: Egg breakfast with high saturated fat<br>* Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam<br>* Other names: Breakfast B;|
| Experimental: Group 2:Test breakfast A and C<br>Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order. | Behavioral: Egg breakfast<br>* 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<br>* Other names: Breakfast A;Behavioral: Cereal breakfast<br>* 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<br>* Other names: Breakfast C;|
| Experimental: Group 3:Test breakfast A and D<br>Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order. | Behavioral: Egg breakfast<br>* 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<br>* Other names: Breakfast A;Behavioral: Cereal breakfast with high saturated fat<br>* 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<br>* Other names: Breakfast D;|
| Experimental: Group 4:Test breakfast B and C<br>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<br>* Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam<br>* Other names: Breakfast B;Behavioral: Cereal breakfast<br>* 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<br>* Other names: Breakfast C;|
| Experimental: Group 5:Test breakfast B and D<br>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<br>* Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam<br>* Other names: Breakfast B;Behavioral: Cereal breakfast with high saturated fat<br>* 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<br>* Other names: Breakfast D;|
| Experimental: Group 6:Test breakfast C and D<br>Subjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order | Behavioral: Cereal breakfast<br>* 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<br>* Other names: Breakfast C;Behavioral: Cereal breakfast with high saturated fat<br>* 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<br>* Other names: Breakfast D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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). | 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. | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of subjective hunger level compared between different test breakfasts | This will be measured on visit 1 and 2 after providing 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) | 
| Difference of subjective satiety level compared between different test breakfasts | This will be measured on visit 1 and 2 after providing 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) | 
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 1-7 of the ecological momentary assessment part (Part I) of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eggs, saturated fat, insulin resistance,