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Biomarkers of Meats and Potatoes Intake. (MEPO)

9 de octubre de 2017 actualizado por: Professor Lars Ove Dragsted, University of Copenhagen

Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.

The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. The test meals contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled potatoes, chips and a control for the potato meals. A standardized diet was provided during sample collection. Blood and urine samples were collected up to 48h primarily for untargeted metabolomic profiling. Blood was further collected to study the effect of the meals on insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum lunch following the test meals.

Descripción general del estudio

Descripción detallada

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:

  1. To identify acute biomarkers of general meat intake by untargeted metabolomics
  2. 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
  3. To identify biomarkers of acute potato intake by untargeted metabolomics
  4. To identify biomarkers that can differentiate between three types of cooking methods
  5. 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:

  1. To validate already known biomarkers of meat intake by targeted metabolomics
  2. To investigate the effect of the interaction between meat and potatoes on satiety, assessed by visual analogue scales
  3. To investigate the effect of the interaction between meat and potatoes on glucose and insulin responses

Tipo de estudio

Intervencionista

Inscripción (Actual)

12

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Urinary meat metabolites (metabolic profiling with mass spectrometry)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Hours 0-7
Measured by the weight of an ad libitum meal
Hours 0-7

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Urine biomarkers of meat intake
Periodo de tiempo: Hours 0-48
Targeted approach with mass spectrometry on already proposed meat biomarkers
Hours 0-48
Subjective assessment of satiety
Periodo de tiempo: Hours 0-6
Assessed by visual analogue scale (VAS)
Hours 0-6
Area under the curve for glucose
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de febrero de 2015

Finalización primaria (Actual)

30 de mayo de 2015

Finalización del estudio (Actual)

30 de mayo de 2015

Fechas de registro del estudio

Enviado por primera vez

4 de octubre de 2017

Primero enviado que cumplió con los criterios de control de calidad

9 de octubre de 2017

Publicado por primera vez (Actual)

10 de octubre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de octubre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

9 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H-15020401

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Meal sequence: 3C1A2B4D

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