Measuring Single-Serving Grain Intake
3 de julio de 2019 actualizado por: Janet Novotny, USDA Beltsville Human Nutrition Research Center
The primary objective of this study is to identify markers of a single meal of whole grain oat and whole grain wheat intake in humans.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of this study is to identify compounds that are found in blood and urine and are derived from a single meal of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Maryland
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Beltsville, Maryland, Estados Unidos, 20705
- USDA-ARS Beltsville Human Nutrition Research Center
-
-
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
21 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 21 to 75 years of age
- Voluntarily agree to participate and sign an informed consent form
Exclusion Criteria:
- Body weight less than 110 lbs.
- Have a body mass index below 19 or above 38 kg/m2
- Known (self-reported) allergy or adverse reaction to study foods
- Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
- History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
- History of certain cancer diagnosis or treatment in the last 3 years
- Smoking or use of tobacco products in the past 6 months
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Whole Grain Oat
Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet.
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A meal containing whole grain oats
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Otro: Whole Grain Wheat
Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet.
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A meal containing whole grain wheat
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Identification of unknown biomarkers of grain intake immediately after grain consumption
Periodo de tiempo: Day 8
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 8
|
|
Identification of unknown biomarkers of grain intake a day after grain consumption
Periodo de tiempo: Day 9
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 9
|
|
Identification of unknown biomarkers of grain intake 2 days after grain consumption
Periodo de tiempo: Day 10
|
Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 10
|
|
Identification of unknown biomarkers of grain intake immediately after grain consumption
Periodo de tiempo: Day 34
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 34
|
|
Identification of unknown biomarkers of grain intake a day after grain consumption
Periodo de tiempo: Day 35
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 35
|
|
Identification of unknown biomarkers of grain intake 2 days after grain consumption
Periodo de tiempo: Day 36
|
Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 36
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood glucose
Periodo de tiempo: Days 8 and 34
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Blood glucose will be measured.
Blood glucose is reported in mmol/L.
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Days 8 and 34
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Serum insulin
Periodo de tiempo: Days 8 and 34
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Serum insulin will be measured.
Serum insulin is reported in mIU/L.
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Days 8 and 34
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Serum c-peptide
Periodo de tiempo: Days 8 and 34
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Serum c-peptide will be measured.
Serum c-peptide is reported in ng/ml.
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Days 8 and 34
|
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Non-esterified fatty acids in blood
Periodo de tiempo: Days 8 and 34
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Non-esterified fatty acids will be measured in blood.
Non-esterified fatty acids are reported as mEQ/L.
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Days 8 and 34
|
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Triglycerides in blood
Periodo de tiempo: Days 8 and 34
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Triglycerides will be measured.
Triglycerides are reported as mmol/L.
|
Days 8 and 34
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
13 de mayo de 2019
Finalización primaria (Actual)
19 de junio de 2019
Finalización del estudio (Actual)
19 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
11 de diciembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
18 de diciembre de 2018
Publicado por primera vez (Actual)
21 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
3 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HS62 - Single Grain
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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