Diabetes Mellitus, Type 2NCT03404700
Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method
A study testing Egg breakfast, Egg breakfast with high saturated fat and Cereal breakfast in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Texas Tech University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Insulin Resistance
- What is being tested?
- Egg breakfast, Egg breakfast with high saturated fat and Cereal breakfast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 3 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes
- On antidiabetes medication
- Pregnant or lactating females
- Having a history of gestational diabetes
- Having an unstable cardiac condition
- Having a major systemic illness
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Being tested
- Egg breakfast, Egg breakfast with high saturated fat, Cereal breakfast, Cereal breakfast with high saturated fat
- Keywords
- Eggs, saturated fat, insulin resistance,
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg breakfastBehavioural
Also called Breakfast A
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 fatBehavioural
Also called Breakfast B
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 breakfastBehavioural
Also called Breakfast C
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 fatBehavioural
Also called Breakfast D
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Behavioral: Cereal breakfast; Behavioral: Cereal breakfast with high saturated fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
This will be measured on visit 1 and 2 after providing test breakfasts.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1-7 of the ecological momentary assessment part (Part I) of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start22 May 2018
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center, American Egg Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404700
- Sponsor's protocol ID
- IRB2017-215
- Status last verified
- Jan 2019
- First submitted
- 22 Dec 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10217054Shin 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.
PubMed 23676423Djousse 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.
PubMed 19017774Wallin 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.
PubMed 26993632Martin 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.
PubMed 22134199Dhanasekara 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.
PubMed 33486223
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method
- ClinicalTrials.gov ID
- NCT03404700
- Acronym / sponsor ID
- IRB2017-215
- Conditions
- Diabetes Mellitus, Type 2, Insulin Resistance
- Keywords
- Eggs, saturated fat, insulin resistance,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center, American Egg Board
- Study start
- 22 May 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1:Test breakfast A and B | Experimental | Behavioral: Egg breakfast, Behavioral: Egg breakfast with high saturated fat*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. |
| Group 2:Test breakfast A and C | Experimental | Behavioral: Egg breakfast, Behavioral: Cereal breakfastSubjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order. |
| Group 3:Test breakfast A and D | Experimental | Behavioral: Egg breakfast, Behavioral: Cereal breakfast with high saturated fatSubjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order. |
| Group 4:Test breakfast B and C | Experimental | Behavioral: Egg breakfast with high saturated fat, Behavioral: Cereal breakfastSubjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast (test breakfast C) in any order. |
| Group 5:Test breakfast B and D | Experimental | Behavioral: Egg breakfast with high saturated fat, Behavioral: Cereal breakfast with high saturated fatSubjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast with high saturated fat (test breakfast D) in any order. |
| Group 6:Test breakfast C and D | Experimental | Behavioral: Cereal breakfast, Behavioral: Cereal breakfast with high saturated fatSubjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Diabetes
- On antidiabetes medication
- Pregnant or lactating females
- Having a history of gestational diabetes
- Having an unstable cardiac condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg breakfastAlso: Breakfast AContaining: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 | Behavioural | 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 fatAlso: Breakfast BContaining:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam | Behavioural | Group 1:Test breakfast A and B, Group 4:Test breakfast B and C, Group 5:Test breakfast B and D |
| Cereal breakfastAlso: Breakfast CContaining: 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 | Behavioural | 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 fatAlso: Breakfast DContaining: 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 | Behavioural | Group 3:Test breakfast A and D, Group 5:Test breakfast B and D, Group 6:Test breakfast C and D |
Primary outcome
Difference of energy intake (kcal) in meals containing eggs as compared to meals that do not contain eggs
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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.
Difference of energy intake (kcal) in high egg consumers as compared to low egg consumers
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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).
Difference of saturated fat (g) intake in meals containing eggs as compared to meals that do not contain eggs
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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.
Difference of saturated fat (g) intake in high egg consumers as compared to low egg consumers
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
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).
Difference of blood glucose levels compared between different test breakfasts
Time frame: 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)
This will be measured on visit 1 and 2 after providing test breakfasts.
Difference of insulin levels compared between different test breakfasts
Time frame: 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)
This will be measured on visit 1 and 2 after providing test breakfasts.
9 secondary outcomes
Difference of subjective hunger level compared between different test breakfasts
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Background: PubMed 10217054Hu 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.
- Background: PubMed 23676423Shin 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.
- Background: PubMed 19017774Djousse 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.
- Background: PubMed 26993632Wallin 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.
- Background: PubMed 22134199Martin 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.
- Derived from this study: PubMed 33486223Dhanasekara 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg breakfast, Egg breakfast with high saturated fat and Cereal breakfast in people with Diabetes Mellitus, Type 2 and Insulin Resistance, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of energy intake (kcal) in meals containing eggs as compared to meals that do not contain eggs (time frame: Day 1-7 of the ecological momentary assessment part (Part I) of the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404700, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.