High Quality Protein for Assisting With Weight Loss
- Conditions
- Obesity
- Interventions
- Behavioral: Egg breakfast (EB)Behavioral: Weight Loss CounselingBehavioral: Weight Loss DietBehavioral: Cereal Breakfast (CB)
- Registration Number
- NCT03085511
- Lead Sponsor
- Texas Tech University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- Overweight and class I-II obese (BMI 25.0-39.9)
- Sedentary (<3 hours/week of moderate intensity physical activity)
- Otherwise healthy
- ≥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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Egg Breakfast (EB) 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. Egg Breakfast (EB) Weight Loss Counseling 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. Egg Breakfast (EB) Weight Loss Diet 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. Cereal Breakfast (CB) Weight Loss Diet 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. Cereal Breakfast (CB) 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. Cereal Breakfast (CB) Weight Loss Counseling 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.
- Primary Outcome Measures
Name Time Method Change of subjective satiety Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14 This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1\&2
Energy intake (kcal) during ad libitum dinner Test day 7 and day 14 Energy intake will be compared between 2 test days in experiment 1
Energy intake (kcal) during ad libitum lunch Test day 7 and day 14 Chocolate brownies will be added to the test lunch. Energy intake will be compared between 2 test days in experiment 2
Change of objective satiety Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. It is measured by ghrelin. This will be tested in experiment 1 and changes will be compared between 2 test days.
Other change of hormone level Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14. It is measured insulin levels. This will be tested in experiment 1 and changes will be compared between 2 test days.
- Secondary Outcome Measures
Name Time Method Change in body weight (kg) Day 0, day 7 and day 14 Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared
Change in waist and hip circumference (cm) Day 0, day 7 and day 14 Waist and hip circumference change from baseline to day 7, and change from day 7 to day 14 will be compared
Change in fat mass and lean body mass percentage Day 0, day 7 and day 14 Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared
Change in blood pressure (mm Hg) Day 0, day 7 and day 14 BP change from baseline to day 7, and change from day 7 to day 14 will be compared
Self report bias in weight, height and body fat percentage Day 0 Difference of measurements between self report survey and objective results
Self report of desire to lose weight and ideal weight Day 0
Trial Locations
- Locations (1)
Texas Tech University - Department of Nutritional Sciences
🇺🇸Lubbock, Texas, United States