- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02497859
Breakfast Intake and Satiety Hormones
Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Lubbock, Texas, United States, 79409
- Texas Tech University - Department of Nutritional Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Calculated BMI of 25.0-39.9 kg/m2
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / 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. |
The EB will receive a breakfast of higher quality protein, but similar in macronutrient and energy density than the active comparator.
The EB will have the following energy density, macronutrient composition, and protein score: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.5%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
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 including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed.
Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling.
Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.
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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. |
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 including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed.
Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling.
Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.
The CB will receive a breakfast of lower quality protein, but similar in macronutrient and energy density than the experimental treatment.
The CB will have the following energy density, macronutrient composition, and protein score: weight 293 g, energy 398 kcal, energy density 1.3 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subjective hunger questionnaire (Visual Analog Scale)
Time Frame: Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
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Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
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Change in serum satiety and hunger hormones
Time Frame: Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
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Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined.
This is only for experiment 1.
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Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
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Energy intake (kcal) during ad libitum lunch
Time Frame: Test day 7 (30 minutes for buffet).
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This is for experiment 1.
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Test day 7 (30 minutes for buffet).
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Energy intake (kcal) during ad libitum lunch
Time Frame: Test day 14 (30 minutes for buffet).
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This is for experiment 1.
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Test day 14 (30 minutes for buffet).
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Energy intake (kcal) during ad libitum dinner
Time Frame: Test day 7 (30 minutes for buffet).
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This is for experiment 1.
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Test day 7 (30 minutes for buffet).
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Energy intake (kcal) during ad libitum dinner
Time Frame: Test day 14 (30 minutes for buffet).
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This is for experiment 1.
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Test day 14 (30 minutes for buffet).
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Energy intake (kcal) during ad libitum lunch
Time Frame: Test day 7 (30 minutes for buffet).
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This is for experiment 2. Chocolate brownies will be added to the test lunch.
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Test day 7 (30 minutes for buffet).
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Energy intake (kcal) during ad libitum lunch
Time Frame: Test day 14 (30 minutes for buffet).
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This is for experiment 2. Chocolate brownies will be added to the test lunch.
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Test day 14 (30 minutes for buffet).
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body weight in kilograms
Time Frame: Change in kilograms from baseline to test day 7.
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Change in kilograms from baseline to test day 7.
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Change in body weight in kilograms
Time Frame: Change in kilograms from test day 7 to test day 14.
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Change in kilograms from test day 7 to test day 14.
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Change in waist and hip circumference in centimeters
Time Frame: Change in centimeters from baseline to test day 7.
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Change in centimeters from baseline to test day 7.
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Change in waist and hip circumference in centimeters
Time Frame: Change in centimeters from test day 7 to test day 14.
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Change in centimeters from test day 7 to test day 14.
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Change in blood pressure (mm Hg)
Time Frame: Change in mm Hg from baseline to test day 7.
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Change in mm Hg from baseline to test day 7.
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Change in blood pressure (mm Hg)
Time Frame: Change in mm Hg from test day 7 to test day 14.
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Change in mm Hg from test day 7 to test day 14.
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Change in fat mass and lean body mass percentage
Time Frame: Change in percentage from test day 0 to test day 14.
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Change in percentage from test day 0 to test day 14.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nikhil Dhurandhar, PhD, Chair of the Nutritional Sciences Department
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 505159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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