Biomarkers of Meats and Potatoes Intake. (MEPO)
Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.
Обзор исследования
Статус
Вмешательство/лечение
- Другой: Meal sequence: 3C1A2B4D
- Другой: Meal sequence: 2A3D4C1B
- Другой: Meal sequence: 2D4B3A1C
- Другой: Meal sequence: 3B2C1D4A
- Другой: Meal sequence: 4C2B1A3D
- Другой: Meal sequence:1B4D3C2A
- Другой: Meal sequence:4A1C2D3B
- Другой: Meal sequence:1D3A4B2C
- Другой: Meal sequence: 4D3B2C1A
- Другой: Meal sequence: 3A4C1B2D
- Другой: Meal sequence: 1C2A3D4B
- Другой: Meal sequence: 2B1D4A3C
Подробное описание
Protein-rich diets improve body weight regulations and are thus believed to play a key role in combating the global obesity epidemic. Protein-rich diets are generally high in meats, some of which have become controverted enough to be considered disease-promoting foods despite their nutritional richness. The degree at which associations with disease differs from causality is however not entirely known.
Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall and dietary records, all of which are self-reporting methods known to be subject to bias and inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the conventional tools as objective measurements of food intake, drawn from biological samples. Several biomarkers of meat consumption have been proposed, however none is currently accepted and used as biomarker(s) of meat intake and none is able to differentiate between the different types of meat.
In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers of potato intake have not been thoroughly reported in the literature. Different cooking methods were shown to potentially influence the content of bioactive constituents of vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking additionally yields the formation of potentially toxic compounds such as advanced glycation endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes. In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between different cooking methods would be of great importance in advancing the understanding of nutritional science.
Primary objectives:
- To identify acute biomarkers of general meat intake by untargeted metabolomics
- To explore the changes in the metabolome as a result of acute exposure to three types of meat and identify meat-specific biomarkers of intake
- To identify biomarkers of acute potato intake by untargeted metabolomics
- To identify biomarkers that can differentiate between three types of cooking methods
- To investigate the effect of the interaction between meat on potatoes on satiety, assessed by registration of intake from an ad libitum meal
Secondary objectives:
- To validate already known biomarkers of meat intake by targeted metabolomics
- To investigate the effect of the interaction between meat and potatoes on satiety, assessed by visual analogue scales
- To investigate the effect of the interaction between meat and potatoes on glucose and insulin responses
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- BMI < 30 kg/m2
- Eating and tolerating meat, egg, pea, rice, and potatoes
- No current chronic or infectious disease
- No medication (oral contraceptive pill and mild antidepressants is allowed)
- No dietary supplements
- Did not use antibiotics in the 6 previous months
Exclusion Criteria:
- Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
- Pregnant or lactating women
- Smoking (12 months of non-smoking is allowed)
- Vegan or vegetarian
- Have or have had a drug addiction
- Blood donations within three months before participating in the current trial or participation in other scientific experiments
- Alcohol consumption higher than the Danish Health Authority recommendation of 7 or 14 drinks/week for women and men, respectively.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Meal sequence: 3C1A2B4D
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D. |
Participants receive test meals in the sequence 3C1A2B4D
|
|
Экспериментальный: Meal sequence: 2A3D4C1B
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B. |
Participants receive test meals in the sequence 2A3D4C1B
|
|
Экспериментальный: Meal sequence: 2D4B3A1C
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C. |
Participants receive test meals in the sequence 2D4B3A1C
|
|
Экспериментальный: Meal sequence: 3B2C1D4A
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A. |
Participants receive test meals in the sequence 3B2C1D4A
|
|
Экспериментальный: Meal sequence: 4C2B1A3D
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D. |
Participants receive test meals in the sequence 4C2B1A3D
|
|
Экспериментальный: Meal sequence:1B4D3C2A
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A. |
Participants receive test meals in the sequence 1B4D3C2A
|
|
Экспериментальный: Meal sequence:4A1C2D3B
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B. |
Participants receive test meals in the sequence 4A1C2D3B
|
|
Экспериментальный: Meal sequence:1D3A4B2C
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C. |
Participants receive test meals in the sequence 1D3A4B2C
|
|
Экспериментальный: Meal sequence: 4D3B2C1A
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A. |
Participants receive test meals in the sequence 4D3B2C1A
|
|
Экспериментальный: Meal sequence: 3A4C1B2D
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D. |
Participants receive test meals in the sequence 3A4C1B2D
|
|
Экспериментальный: Meal sequence: 1C2A3D4B
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B. |
Participants receive test meals in the sequence 1C2A3D4B
|
|
Экспериментальный: Meal sequence: 2B1D4A3C
In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C. |
Participants receive test meals in the sequence 2B1D4A3C
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Urinary meat metabolites (metabolic profiling with mass spectrometry)
Временное ограничение: Hours 0-48
|
Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat
|
Hours 0-48
|
|
Plasma meat metabolites (metabolic profiling with mass spectrometry)
Временное ограничение: Hours 0-48
|
Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat
|
Hours 0-48
|
|
Urinary potato metabolites (metabolic profiling with mass spectrometry)
Временное ограничение: Hours 0-48
|
Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods
|
Hours 0-48
|
|
Plasma potato metabolites (metabolic profiling with mass spectrometry)
Временное ограничение: Hours 0-48
|
Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods
|
Hours 0-48
|
|
Objective assessment of satiety
Временное ограничение: Hours 0-7
|
Measured by the weight of an ad libitum meal
|
Hours 0-7
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Urine biomarkers of meat intake
Временное ограничение: Hours 0-48
|
Targeted approach with mass spectrometry on already proposed meat biomarkers
|
Hours 0-48
|
|
Subjective assessment of satiety
Временное ограничение: Hours 0-6
|
Assessed by visual analogue scale (VAS)
|
Hours 0-6
|
|
Area under the curve for glucose
Временное ограничение: Minutes 0-180
|
Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
|
Minutes 0-180
|
|
Area under the curve for insulin
Временное ограничение: Minutes 0-180
|
Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
|
Minutes 0-180
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- H-15020401
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .
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-
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