Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404700
• Other study ID #: IRB2017-215
• Status: Completed
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: October 3, 2018

Study information

• Verified date: January 2019
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 3, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Behavioral:
• Egg breakfast
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
• Egg breakfast with high saturated fat
Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam
• Cereal breakfast
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
• Cereal breakfast with high saturated fat
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

Locations

Country	Name	City	State
United States	Texas Tech University - Department of Nutritional Sciences	Lubbock	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Tech University	American Egg Board, Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Djoussé L, Gaziano JM, Buring JE, Lee IM. Egg consumption and risk of type 2 diabetes in men and women. Diabetes Care. 2009 Feb;32(2):295-300. doi: 10.2337/dc08-1271. Epub 2008 Nov 18. — View Citation

Hu FB, Stampfer MJ, Rimm EB, Manson JE, Ascherio A, Colditz GA, Rosner BA, Spiegelman D, Speizer FE, Sacks FM, Hennekens CH, Willett WC. A prospective study of egg consumption and risk of cardiovascular disease in men and women. JAMA. 1999 Apr 21;281(15):1387-94. — View Citation

Martin CK, Correa JB, Han H, Allen HR, Rood JC, Champagne CM, Gunturk BK, Bray GA. Validity of the Remote Food Photography Method (RFPM) for estimating energy and nutrient intake in near real-time. Obesity (Silver Spring). 2012 Apr;20(4):891-9. doi: 10.1038/oby.2011.344. Epub 2011 Dec 1. — View Citation

Shin JY, Xun P, Nakamura Y, He K. Egg consumption in relation to risk of cardiovascular disease and diabetes: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Jul;98(1):146-59. doi: 10.3945/ajcn.112.051318. Epub 2013 May 15. Review. — View Citation

Wallin A, Forouhi NG, Wolk A, Larsson SC. Egg consumption and risk of type 2 diabetes: a prospective study and dose-response meta-analysis. Diabetologia. 2016 Jun;59(6):1204-13. doi: 10.1007/s00125-016-3923-6. Epub 2016 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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