ClinicalTrials.Veeva

Menu

Determining Dietary Pattern Accompanying Egg Intake Using Remote Food Photography Method

T

Texas Tech University

Status

Completed

Conditions

Insulin Resistance
Diabetes Mellitus, Type 2

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03404700
IRB2017-215

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

48 participants in 6 patient groups

Group 1:Test breakfast A and B
Experimental group
Description:
\*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.
Treatment:
Behavioral: Egg breakfast with high saturated fat
Behavioral: Egg breakfast
Group 2:Test breakfast A and C
Experimental group
Description:
Subjects will have egg breakfast and (test breakfast A) and cereal breakfast (test breakfast C) in any order.
Treatment:
Behavioral: Cereal breakfast
Behavioral: Egg breakfast
Group 3:Test breakfast A and D
Experimental group
Description:
Subjects will have egg breakfast (test breakfast A) and cereal breakfast (test breakfast C) in any order.
Treatment:
Behavioral: Cereal breakfast with high saturated fat
Behavioral: Egg breakfast
Group 4:Test breakfast B and C
Experimental group
Description:
Subjects will have egg breakfast with high saturated fat (test breakfast B) and cereal breakfast (test breakfast C) in any order.
Treatment:
Behavioral: Egg breakfast with high saturated fat
Behavioral: Cereal breakfast
Group 5:Test breakfast B and D
Experimental group
Description:
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.
Treatment:
Behavioral: Egg breakfast with high saturated fat
Behavioral: Cereal breakfast with high saturated fat
Group 6:Test breakfast C and D
Experimental group
Description:
Subjects will have cereal breakfast (test breakfast C) and cereal breakfast with high saturated fat (test breakfast D) in any order
Treatment:
Behavioral: Cereal breakfast
Behavioral: Cereal breakfast with high saturated fat

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems