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High Quality Protein for Assisting With Weight Loss (Egg_breakfast)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Egg breakfast (EB)
Weight Loss Counseling
Weight Loss Diet
Cereal Breakfast (CB)
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Egg breakfast, Weight loss, Satiety, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose, Protein quality

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight and class I-II obese (BMI 25.0-39.9)
  • Sedentary (<3 hours/week of moderate intensity physical activity)
  • Otherwise healthy

Exclusion Criteria:

  • ≥5% body weight loss or gain in the three months preceding the study
  • Post-menopausal (has not had period for 12 months)
  • Plans to begin an exercise program or change current exercise routines between initiation of study and final study
  • Anyone following a medical diet prescription
  • Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type
  • Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet: Unstable cardiac condition; Polycystic ovary syndrome; Prader-Willi syndrome; Major systemic illness; History of recreational drug abuse or eating disorder (Binge Eating Disorder); Familial hyperlipidemia; Major endocrine diseases (Cushing's syndrome, Grave's disease, Hashimoto's thyroiditis); Gastrointestinal disorder
  • Anyone who is currently pregnant, or lactating
  • Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling
  • Plans to begin taking any supplements that may influence weight loss
  • Report of medical condition or surgical intervention that affects swallowing or chewing ability
  • Anyone with a pacemaker or other internal medical device
  • Any practicing vegans or vegetarians
  • Any practicing gluten-free diet
  • Allergy, aversion, or dislike to any of the foods offered for meals

Sites / Locations

  • Texas Tech University - Department of Nutritional Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Egg Breakfast (EB)

Cereal Breakfast (CB)

Arm Description

The EB will receive the following breakfast: 2 scrambled eggs, 120 mL skim milk, 2 slices of Mrs. Bairds® Extra Thin White Bread, 5 g of butter, and 18 g of Smuckers® Strawberry Jam.

The CB will receive the following breakfast: 1.5 cups of Special K® Ready-to-Eat Original Cereal, 200 ml Silk® Original Soymilk, 1 slice of Nature's Own® Double Fiber Wheat Bread, 13 g of butter, and 10 g of Smuckers® Sugar-Free Strawberry Jam.

Outcomes

Primary Outcome Measures

Change of subjective satiety
This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1&2
Change of objective satiety
It is measured by GLP-1. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change of objective satiety
It is measured by PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.
Change of objective satiety
It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.
Other change of hormone level
It is measured by serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.
Other change of hormone level
It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.
Energy intake (kcal) during ad libitum lunch
Energy intake will be compared between 2 test days in experiment 1
Energy intake (kcal) during ad libitum dinner
Energy intake will be compared between 2 test days in experiment 1
Energy intake (kcal) during ad libitum lunch
Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2

Secondary Outcome Measures

Change in body weight (kg)
Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared
Change in waist and hip circumference (cm)
Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared
Change in blood pressure (mm Hg)
BP change from baseline to day 7, and change from day 7 to day 14 will be compared
Change in fat mass and lean body mass percentage
Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared
Self report bias in weight, height and body fat percentage
Difference of measurements between self report survey and objective results
Self report of desire to lose weight and ideal weight

Full Information

First Posted
March 15, 2017
Last Updated
May 28, 2019
Sponsor
Texas Tech University
Collaborators
American Egg Board
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1. Study Identification

Unique Protocol Identification Number
NCT03085511
Brief Title
High Quality Protein for Assisting With Weight Loss
Acronym
Egg_breakfast
Official Title
Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
Collaborators
American Egg Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if, in presence of a reduced calorie diet, a breakfast containing high quality protein source (eggs) would be more effective in reducing hunger and increasing feeling of fullness compared to a breakfast containing a lower quality of protein, but equal energy density. A previous pilot study with the same endpoints yielded borderline significant results; this study has been powered based on that pilot to interrogate our hypotheses.
Detailed Description
This will be a crossover study with 2 experiments. Subjects will follow a reduced energy weight loss diet of 1,200-1,500 kcal adjusted to each individual's body weight for totally 2 weeks in each experiment. They will come to the clinic from day 1 to day 7 and consume egg breakfast (EB) for 5 days under our supervision. Then on weekends during this period they will continue this breakfast at home based on our advice. The next week they will have cereal breakfast (CB) and the process is similar to that in the first week. The 1st experiment will test the satiety from egg breakfast (EB) and following energy intake in both lunch and dinner, compared with CB (cereal breakfast). Lunch and dinner will be offered on 2 test days during each week. Anthropometric and body composition measurements, blood pressure, blood draw, satiety questionnaire, as well as energy intake will also be collected in the 2 test days and compared between 2 breakfast groups. The 2nd one is to test whether EB will help in resisting the intake of foods considered tempting, but detrimental to weight loss efforts, compared with CB. The process is similar to experiment 1 except no blood draw, no dinner offered. Instead, a tempting food after lunch will be offered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Egg breakfast, Weight loss, Satiety, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose, Protein quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Within subjects comparison will be performed. Subjects will be assigned to either group A (EB first then CB) or group B (CB first then EB) for a week and then reverse to the opposite breakfast the next week
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg Breakfast (EB)
Arm Type
Experimental
Arm Description
The EB will receive the following breakfast: 2 scrambled eggs, 120 mL skim milk, 2 slices of Mrs. Bairds® Extra Thin White Bread, 5 g of butter, and 18 g of Smuckers® Strawberry Jam.
Arm Title
Cereal Breakfast (CB)
Arm Type
Active Comparator
Arm Description
The CB will receive the following breakfast: 1.5 cups of Special K® Ready-to-Eat Original Cereal, 200 ml Silk® Original Soymilk, 1 slice of Nature's Own® Double Fiber Wheat Bread, 13 g of butter, and 10 g of Smuckers® Sugar-Free Strawberry Jam.
Intervention Type
Behavioral
Intervention Name(s)
Egg breakfast (EB)
Intervention Description
Breakfast is considered as high quality protein diet, but has similar weight, energy, and macronutrients as the active comparator. The details are as follows: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.6%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Counseling
Intervention Description
Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics will include portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, as well as behavioral strategies including self-monitoring, motivational interviewing, goal setting, and problem solving.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Diet
Intervention Description
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
Intervention Type
Behavioral
Intervention Name(s)
Cereal Breakfast (CB)
Intervention Description
Breakfast is considered as low quality protein diet, but has similar weight, energy, and macronutrients as that in experimental group. The details are as follows: weight 293 g, energy 398 kcal, energy density 1.36 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.
Primary Outcome Measure Information:
Title
Change of subjective satiety
Description
This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1&2
Time Frame
Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
Title
Change of objective satiety
Description
It is measured by GLP-1. This will be tested in experiment 1 and changes will be compared between 2 test days.
Time Frame
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
Title
Change of objective satiety
Description
It is measured by PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.
Time Frame
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Title
Change of objective satiety
Description
It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.
Time Frame
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Title
Other change of hormone level
Description
It is measured by serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.
Time Frame
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Title
Other change of hormone level
Description
It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.
Time Frame
Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
Title
Energy intake (kcal) during ad libitum lunch
Description
Energy intake will be compared between 2 test days in experiment 1
Time Frame
Test day 7 and day 14
Title
Energy intake (kcal) during ad libitum dinner
Description
Energy intake will be compared between 2 test days in experiment 1
Time Frame
Test day 7 and day 14
Title
Energy intake (kcal) during ad libitum lunch
Description
Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2
Time Frame
Test day 7 and day 14
Secondary Outcome Measure Information:
Title
Change in body weight (kg)
Description
Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared
Time Frame
Day 0, day 7 and day 14
Title
Change in waist and hip circumference (cm)
Description
Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared
Time Frame
Day 0, day 7 and day 14
Title
Change in blood pressure (mm Hg)
Description
BP change from baseline to day 7, and change from day 7 to day 14 will be compared
Time Frame
Day 0, day 7 and day 14
Title
Change in fat mass and lean body mass percentage
Description
Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared
Time Frame
Day 0, day 7 and day 14
Title
Self report bias in weight, height and body fat percentage
Description
Difference of measurements between self report survey and objective results
Time Frame
Day 0
Title
Self report of desire to lose weight and ideal weight
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Overweight and class I-II obese (BMI 25.0-39.9) Sedentary (<3 hours/week of moderate intensity physical activity) Otherwise healthy Exclusion Criteria: ≥5% body weight loss or gain in the three months preceding the study Post-menopausal (has not had period for 12 months) Plans to begin an exercise program or change current exercise routines between initiation of study and final study Anyone following a medical diet prescription Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet: Unstable cardiac condition; Polycystic ovary syndrome; Prader-Willi syndrome; Major systemic illness; History of recreational drug abuse or eating disorder (Binge Eating Disorder); Familial hyperlipidemia; Major endocrine diseases (Cushing's syndrome, Grave's disease, Hashimoto's thyroiditis); Gastrointestinal disorder Anyone who is currently pregnant, or lactating Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling Plans to begin taking any supplements that may influence weight loss Report of medical condition or surgical intervention that affects swallowing or chewing ability Anyone with a pacemaker or other internal medical device Any practicing vegans or vegetarians Any practicing gluten-free diet Allergy, aversion, or dislike to any of the foods offered for meals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Dhurandhar
Organizational Affiliation
Chair of the Nutritional Sciences Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University - Department of Nutritional Sciences
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24703415
Citation
Bayham BE, Greenway FL, Johnson WD, Dhurandhar NV. A randomized trial to manipulate the quality instead of quantity of dietary proteins to influence the markers of satiety. J Diabetes Complications. 2014 Jul-Aug;28(4):547-52. doi: 10.1016/j.jdiacomp.2014.02.002. Epub 2014 Feb 13.
Results Reference
background
PubMed Identifier
18679412
Citation
Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.
Results Reference
background
PubMed Identifier
16373948
Citation
Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
Results Reference
background

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High Quality Protein for Assisting With Weight Loss

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