Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method

NCT03404700 | Completed

• 1 other identifier: IRB2017-215
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Keywords

Eggs, saturated fat, insulin resistance,

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (6)

Group 1:Test breakfast A and B

EXPERIMENTAL

\*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; Behavioral: Egg breakfast with high saturated fat

Group 2:Test breakfast A and C

EXPERIMENTAL

Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order.

Behavioral: Egg breakfast; Behavioral: Cereal breakfast

Group 3:Test breakfast A and D

EXPERIMENTAL

Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order.

Behavioral: Egg breakfast; Behavioral: Cereal breakfast with high saturated fat

Group 4:Test breakfast B and C

EXPERIMENTAL

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; Behavioral: Cereal breakfast

Group 5:Test breakfast B and D

EXPERIMENTAL

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; Behavioral: Cereal breakfast with high saturated fat

Group 6:Test breakfast C and D

EXPERIMENTAL

Subjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order

Behavioral: Cereal breakfast; Behavioral: Cereal breakfast with high saturated fat

Interventions

Egg breakfast BEHAVIORAL

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

Also known as: Breakfast A

Group 1:Test breakfast A and B; Group 2:Test breakfast A and C; Group 3:Test breakfast A and D

Egg breakfast with high saturated fat BEHAVIORAL

Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam

Also known as: Breakfast B

Group 1:Test breakfast A and B; Group 4:Test breakfast B and C; Group 5:Test breakfast B and D

Cereal breakfast BEHAVIORAL

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

Also known as: Breakfast C

Group 2:Test breakfast A and C; Group 4:Test breakfast B and C; Group 6:Test breakfast C and D

Cereal breakfast with high saturated fat BEHAVIORAL

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

Also known as: Breakfast D

Group 3:Test breakfast A and D; Group 5:Test breakfast B and D; Group 6:Test breakfast C and D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead
• Pennington Biomedical Research Center: collaborator
• American Egg Board: collaborator

Study Sites (1)

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Location

Related Publications (6)

• 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. doi: 10.1001/jama.281.15.1387.

  PMID: 10217054 BACKGROUND

• 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.

  PMID: 23676423 BACKGROUND

• Djousse 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.

  PMID: 19017774 BACKGROUND

• 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.

  PMID: 26993632 BACKGROUND

• 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.

  PMID: 22134199 BACKGROUND

• Dhanasekara CS, Dawson JA, Martin CK, Dhurandhar NV. No association between consumption of eggs with energy or macronutrient intake: Objective evidence from the remote food photography method. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):313-318. doi: 10.1016/j.dsx.2021.01.010. Epub 2021 Jan 15.

  PMID: 33486223 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 19, 2018
• Study Start: May 22, 2018
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)