Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03404700
Study type Interventional
Source Texas Tech University
Contact
Status Completed
Phase N/A
Start date May 22, 2018
Completion date October 3, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2