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| Name | Class |
|---|---|
| American Egg Board | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egg Breakfast (EB) | Experimental | 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. |
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| Cereal Breakfast (CB) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egg breakfast (EB) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikhil Dhurandhar | Chair of the Nutritional Sciences Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Tech University - Department of Nutritional Sciences | Lubbock | Texas | 79409 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24703415 | Background | 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. | |
| 18679412 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004038 | Diet, Reducing |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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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
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| Weight Loss Counseling | Behavioral | 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. |
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| Weight Loss Diet | Behavioral | Participants will have a 1200-1500kcals diet based on each individual's body weight during the study. |
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| Cereal Breakfast (CB) | Behavioral | 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. |
|
| Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. |
| 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 |
| 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 |
| 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 |
| Day 0, day 7 and day 14 |
| 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 |
| 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 |
| Self report bias in weight, height and body fat percentage | Difference of measurements between self report survey and objective results | Day 0 |
| Self report of desire to lose weight and ideal weight | Day 0 |
| 16373948 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |