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Trial record 3 of 6 for:    Recruiting, Not yet recruiting, Available Studies | "Diet, Reducing"

High Quality Protein for Assisting With Weight Loss (Egg_breakfast)

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ClinicalTrials.gov Identifier: NCT03085511
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Texas Tech University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Egg breakfast (EB) Behavioral: Weight Loss Counseling Behavioral: Weight Loss Diet Behavioral: Cereal Breakfast (CB) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egg Breakfast (EB)

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.

Behavioral: Egg breakfast (EB)
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.

Behavioral: Weight Loss Counseling
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.

Behavioral: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.

Active Comparator: Cereal Breakfast (CB)

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.

Behavioral: Weight Loss Counseling
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.

Behavioral: Weight Loss Diet
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.

Behavioral: Cereal Breakfast (CB)
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 Measures :
  1. Change of subjective satiety [ 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 ]
    This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1&2

  2. Change of objective satiety [ Time Frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14 ]
    It is measured by GLP-1. This will be tested in experiment 1 and changes will be compared between 2 test days.

  3. Change of objective satiety [ Time Frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. ]
    It is measured by PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.

  4. Change of objective satiety [ Time Frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. ]
    It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.

  5. Other change of hormone level [ Time Frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. ]
    It is measured by serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.

  6. Other change of hormone level [ Time Frame: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. ]
    It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.

  7. Energy intake (kcal) during ad libitum lunch [ Time Frame: Test day 7 and day 14 ]
    Energy intake will be compared between 2 test days in experiment 1

  8. Energy intake (kcal) during ad libitum dinner [ Time Frame: Test day 7 and day 14 ]
    Energy intake will be compared between 2 test days in experiment 1

  9. Energy intake (kcal) during ad libitum lunch [ Time Frame: Test day 7 and day 14 ]
    Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2


Secondary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: Day 0, day 7 and day 14 ]
    Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared

  2. Change in waist and hip circumference (cm) [ Time Frame: Day 0, day 7 and day 14 ]
    Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared

  3. Change in blood pressure (mm Hg) [ Time Frame: Day 0, day 7 and day 14 ]
    BP change from baseline to day 7, and change from day 7 to day 14 will be compared

  4. Change in fat mass and lean body mass percentage [ Time Frame: Day 0, day 7 and day 14 ]
    Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared

  5. Self report bias in weight, height and body fat percentage [ Time Frame: Day 0 ]
    Difference of measurements between self report survey and objective results

  6. Self report of desire to lose weight and ideal weight [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085511


Contacts
Contact: Nikhil Dhurandhar, PhD 8068346446 nikhil.dhurandhar@ttu.edu

Locations
United States, Texas
Texas Tech University - Department of Nutritional Sciences Recruiting
Lubbock, Texas, United States, 79409
Contact: Nikhil Dhurandhar, Ph.D.    806-834-6446    nikhil.dhurandhar@ttu.edu   
Sponsors and Collaborators
Texas Tech University
American Egg Board
Investigators
Principal Investigator: Nikhil Dhurandhar Chair of the Nutritional Sciences Department

Publications:
Responsible Party: Texas Tech University
ClinicalTrials.gov Identifier: NCT03085511     History of Changes
Other Study ID Numbers: TTU IRB2016-1137
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Texas Tech University:
Egg breakfast
Weight loss
Satiety
Insulin
Glucagon-Like Peptide 1
PYY (3-36) peptide
Ghrelin
Glucose
Protein quality

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms