Breakfast Intake and Satiety Hormones
Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?
1 other identifier
interventional
20
1 country
1
Brief Summary
The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2015
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 16, 2016
September 1, 2016
8 months
July 8, 2015
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Change in subjective hunger questionnaire (Visual Analog Scale)
Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Change in serum satiety and hunger hormones
Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined. This is only for experiment 1.
Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Energy intake (kcal) during ad libitum lunch
This is for experiment 1.
Test day 7 (30 minutes for buffet).
Energy intake (kcal) during ad libitum lunch
This is for experiment 1.
Test day 14 (30 minutes for buffet).
Energy intake (kcal) during ad libitum dinner
This is for experiment 1.
Test day 7 (30 minutes for buffet).
Energy intake (kcal) during ad libitum dinner
This is for experiment 1.
Test day 14 (30 minutes for buffet).
Energy intake (kcal) during ad libitum lunch
This is for experiment 2. Chocolate brownies will be added to the test lunch.
Test day 7 (30 minutes for buffet).
Energy intake (kcal) during ad libitum lunch
This is for experiment 2. Chocolate brownies will be added to the test lunch.
Test day 14 (30 minutes for buffet).
Secondary Outcomes (7)
Change in body weight in kilograms
Change in kilograms from baseline to test day 7.
Change in body weight in kilograms
Change in kilograms from test day 7 to test day 14.
Change in waist and hip circumference in centimeters
Change in centimeters from baseline to test day 7.
Change in waist and hip circumference in centimeters
Change in centimeters from test day 7 to test day 14.
Change in blood pressure (mm Hg)
Change in mm Hg from baseline to test day 7.
- +2 more secondary outcomes
Study Arms (2)
Egg Breakfast (EB)
EXPERIMENTALThe 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.
Cereal Breakfast (CB)
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Calculated BMI of 25.0-39.9 kg/m2
- Sedentary (\< 3 hours/week of moderate intensity physical activity)
- Otherwise healthy
You may not qualify if:
- ≥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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Texas Tech Universitylead
- American Egg Boardcollaborator
Study Sites (1)
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409, United States
Related Publications (3)
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.
PMID: 24703415BACKGROUNDVander 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.
PMID: 18679412BACKGROUNDVander 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.
PMID: 16373948BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikhil Dhurandhar, PhD
Chair of the Nutritional Sciences Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 8, 2015
First Posted
July 15, 2015
Study Start
September 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
September 16, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share