Obesity Clinical Trial
— Egg_breakfastOfficial title:
Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
Verified date | May 2019 |
Source | Texas Tech University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 17, 2019 |
Est. primary completion date | May 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University - Department of Nutritional Sciences | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University | American Egg Board |
United States,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14 | |
Primary | 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 in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14 | |
Primary | 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 in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. | |
Primary | 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. | Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. | |
Primary | 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. | Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. | |
Primary | 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. | Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. | |
Primary | Energy intake (kcal) during ad libitum lunch | Energy intake will be compared between 2 test days in experiment 1 | Test day 7 and day 14 | |
Primary | Energy intake (kcal) during ad libitum dinner | Energy intake will be compared between 2 test days in experiment 1 | Test day 7 and day 14 | |
Primary | 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 | Test day 7 and day 14 | |
Secondary | Change in body weight (kg) | Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared | Day 0, day 7 and day 14 | |
Secondary | 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 | Day 0, day 7 and day 14 | |
Secondary | Change in blood pressure (mm Hg) | BP change from baseline to day 7, and change from day 7 to day 14 will be compared | Day 0, day 7 and day 14 | |
Secondary | 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 | Day 0, day 7 and day 14 | |
Secondary | Self report bias in weight, height and body fat percentage | Difference of measurements between self report survey and objective results | Day 0 | |
Secondary | Self report of desire to lose weight and ideal weight | Day 0 |
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