Clinical trial NCT02497859: Breakfast Intake and Satiety Hormones
Official title: Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Reduction
Weight Loss Diet
Satiety Response
Insulin
Glucagon-Like Peptide 1
PYY (3-36) peptide
Ghrelin
Glucose
Eggs
Protein
Energy Intake
Breakfast
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2015-07-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.

Eligibility criteria: 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

Primary outcomes:
measure: Change in subjective hunger questionnaire (Visual Analog Scale)
timeFrame: Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
measure: Change in serum satiety and hunger hormones
timeFrame: Change (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
measure: Energy intake (kcal) during ad libitum lunch
timeFrame: Test day 7 (30 minutes for buffet).
measure: Energy intake (kcal) during ad libitum lunch
timeFrame: Test day 14 (30 minutes for buffet).
measure: Energy intake (kcal) during ad libitum dinner
timeFrame: Test day 7 (30 minutes for buffet).
measure: Energy intake (kcal) during ad libitum dinner
timeFrame: Test day 14 (30 minutes for buffet).
measure: Energy intake (kcal) during ad libitum lunch
timeFrame: Test day 7 (30 minutes for buffet).
measure: Energy intake (kcal) during ad libitum lunch
timeFrame: Test day 14 (30 minutes for buffet).
Secondary outcomes:
measure: Change in body weight in kilograms
timeFrame: Change in kilograms from baseline to test day 7.
measure: Change in body weight in kilograms
timeFrame: Change in kilograms from test day 7 to test day 14.
measure: Change in waist and hip circumference in centimeters
timeFrame: Change in centimeters from baseline to test day 7.
measure: Change in waist and hip circumference in centimeters
timeFrame: Change in centimeters from test day 7 to test day 14.
measure: Change in blood pressure (mm Hg)
timeFrame: Change in mm Hg from baseline to test day 7.
measure: Change in blood pressure (mm Hg)
timeFrame: Change in mm Hg from test day 7 to test day 14.
measure: Change in fat mass and lean body mass percentage
timeFrame: Change in percentage from test day 0 to test day 14.
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University - Department of Nutritional Sciences
state: Texas
Study officials:
affiliation: Chair of the Nutritional Sciences Department
name: Nikhil Dhurandhar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.