Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of subjective satiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Overweight and class I-II obese (BMI 25.0-39.9)
- •Sedentary (<3 hours/week of moderate intensity physical activity)
- •Otherwise healthy
排除标准
- •≥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
研究组 & 干预措施
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.
干预措施: Egg breakfast (EB) (Behavioral)
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.
干预措施: Weight Loss Counseling (Behavioral)
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.
干预措施: Weight Loss Diet (Behavioral)
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.
干预措施: Weight Loss Counseling (Behavioral)
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.
干预措施: Weight Loss Diet (Behavioral)
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.
干预措施: Cereal Breakfast (CB) (Behavioral)
结局指标
主要结局
Change of subjective satiety
时间窗: 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
时间窗: Test day 7 and day 14
Energy intake will be compared between 2 test days in experiment 1
Change of objective satiety
时间窗: 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 PYY 3-36. This will be tested in experiment 1 and changes will be compared between 2 test days.
Other change of hormone level
时间窗: 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 serum glucose. This will be tested in experiment 1 and changes will be compared between 2 test days.
Energy intake (kcal) during ad libitum lunch
时间窗: Test day 7 and day 14
Energy intake will be compared between 2 test days in experiment 1
次要结局
- Change in body weight (kg)(Day 0, day 7 and day 14)
- Change in waist and hip circumference (cm)(Day 0, day 7 and day 14)
- Change in fat mass and lean body mass percentage(Day 0, day 7 and day 14)
- Change in blood pressure (mm Hg)(Day 0, day 7 and day 14)
- Self report bias in weight, height and body fat percentage(Day 0)
- Self report of desire to lose weight and ideal weight(Day 0)