Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

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.
    

Intervention name(s): Egg breakfast; Egg breakfast with high saturated fat; Cereal breakfast; Cereal breakfast with high saturated fat
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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; Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam; 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; 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 intervention name(s): Breakfast A; Breakfast B; Breakfast C; Breakfast D
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Other
Keywords: Eggs, saturated fat, insulin resistance,