Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method
NCT ID: NCT03404700
Last Updated: 2019-01-14
Study Results
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Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2018-05-22
2018-10-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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).
OTHER
NONE
Study Groups
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Group 1:Test breakfast A and B
\*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.
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
Group 2:Test breakfast A and C
Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order.
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
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
Group 3:Test breakfast A and D
Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order.
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
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
Group 4:Test breakfast B and C
Subjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast (test breakfast C) in any order.
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
Group 5:Test breakfast B and D
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.
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 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
Group 6:Test breakfast C and D
Subjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female
* BMI from greater or equal to 20 to lesser or equal 60 kg/m2
* Age: 18 - 65 years
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Pennington Biomedical Research Center
OTHER
American Egg Board
OTHER
Texas Tech University
OTHER
Responsible Party
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Locations
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Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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IRB2017-215
Identifier Type: -
Identifier Source: org_study_id
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