High Quality Protein for Assisting With Weight Loss (Egg_breakfast)
28 мая 2019 г. обновлено: Texas Tech University
Does Higher Protein Quality Reduce Energy Intake When Following a Weight Loss Diet Plan? -- Nonpilot, Powered Crossover
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.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
40
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Texas
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Lubbock, Texas, Соединенные Штаты, 79409
- Texas Tech University - Department of Nutritional Sciences
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 44 года (Взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Женский
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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. |
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.
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.
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
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Активный компаратор: 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. |
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.
Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change of subjective satiety
Временное ограничение: Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
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This will be measured by questionnaire (VAS) and compared the changes between 2 test days (day 7 and day 14) in experiment 1&2
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Change in scores (arbitrary units AUC) from 30 minutes before breakfast consumption to 240 minutes after the consumption on day 7 and day 14
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Change of objective satiety
Временное ограничение: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
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It is measured by GLP-1.
This will be tested in experiment 1 and changes will be compared between 2 test days.
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Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14
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Change of objective satiety
Временное ограничение: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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It is measured by PYY 3-36.
This will be tested in experiment 1 and changes will be compared between 2 test days.
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Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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Change of objective satiety
Временное ограничение: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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It is measured by ghrelin.
This will be tested in experiment 1 and changes will be compared between 2 test days.
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Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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Other change of hormone level
Временное ограничение: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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It is measured by serum glucose.
This will be tested in experiment 1 and changes will be compared between 2 test days.
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Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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Other change of hormone level
Временное ограничение: Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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It is measured insulin levels.
This will be tested in experiment 1 and changes will be compared between 2 test days.
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Change in concentration (AUC) from 30 minutes before breakfast consumption to 180 minutes after the consumption on day 7 and day 14.
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Energy intake (kcal) during ad libitum lunch
Временное ограничение: Test day 7 and day 14
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Energy intake will be compared between 2 test days in experiment 1
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Test day 7 and day 14
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Energy intake (kcal) during ad libitum dinner
Временное ограничение: Test day 7 and day 14
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Energy intake will be compared between 2 test days in experiment 1
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Test day 7 and day 14
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Energy intake (kcal) during ad libitum lunch
Временное ограничение: Test day 7 and day 14
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Chocolate brownies will be added to the test lunch.
Energy intake will be compared between 2 test days in experiment 2
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Test day 7 and day 14
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in body weight (kg)
Временное ограничение: Day 0, day 7 and day 14
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Body weight change from baseline to day 7, and change from day 7 to day 14 will be compared
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Day 0, day 7 and day 14
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Change in waist and hip circumference (cm)
Временное ограничение: Day 0, day 7 and day 14
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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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Day 0, day 7 and day 14
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Change in blood pressure (mm Hg)
Временное ограничение: Day 0, day 7 and day 14
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BP change from baseline to day 7, and change from day 7 to day 14 will be compared
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Day 0, day 7 and day 14
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Change in fat mass and lean body mass percentage
Временное ограничение: Day 0, day 7 and day 14
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Body fat change from baseline to day 7, and change from day 7 to day 14 will be compared
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Day 0, day 7 and day 14
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Self report bias in weight, height and body fat percentage
Временное ограничение: Day 0
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Difference of measurements between self report survey and objective results
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Day 0
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Self report of desire to lose weight and ideal weight
Временное ограничение: Day 0
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Day 0
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Nikhil Dhurandhar, Chair of the Nutritional Sciences Department
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
- 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.
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
20 августа 2017 г.
Первичное завершение (Действительный)
17 мая 2019 г.
Завершение исследования (Действительный)
17 мая 2019 г.
Даты регистрации исследования
Первый отправленный
15 марта 2017 г.
Впервые представлено, что соответствует критериям контроля качества
15 марта 2017 г.
Первый опубликованный (Действительный)
21 марта 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
30 мая 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 мая 2019 г.
Последняя проверка
1 мая 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- TTU IRB2016-1137
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .