Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
30 de mayo de 2017 actualizado por: William Rumpler, USDA Beltsville Human Nutrition Research Center
The objective is to develop a new metabolic flexibility biomarker, which has application in the study of changes diet and exercise on fuel management in humans.
The new biomarker involves the characterization of an individual's metabolic flexibility utilizing room calorimeters rather than the current method, which is based on glucose clamp data.
It is hypothesized that this new metabolic flexibility method will be a useful and noninvasive biomarker for measuring adaptation to exercise and diet challenges.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
16
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
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Maryland
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Beltsville, Maryland, Estados Unidos, 20705
- USDA Beltsville Human Nutrition Center
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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
22 años a 35 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males and Females
- Age 22 to 35 years at beginning of study
Exclusion Criteria:
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- History or presence of diabetes, kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes.
- History of bariatric or certain other surgeries related to weight control
- Smokers or other tobacco users (for at least 6 months prior to the start of the study)
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
- 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 acute treatment or rehabilitation program 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
- Inclusion and exclusion criteria have been established to recruit a population of individuals across a wide age-range that has typical digestive process
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High Intensity Exercise, High Carbohydrate Beverage
Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.
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While in the calorimeter, each subject will complete four bouts of exercise.
Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously.
Subjects then sit quietly until either the next meal or the next exercise bout.
Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.
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Experimental: High Intensity Exercise, High Fat Beverage
Study participant consumes a high fat beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.
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While in the calorimeter, each subject will complete four bouts of exercise.
Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously.
Subjects then sit quietly until either the next meal or the next exercise bout.
Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
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Experimental: Low Intensity Exercise, High Carbohydrate Beverage
Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.
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Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.
While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max.
Subjects then sit quietly until the next meal.
|
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Experimental: Low Intensity Exercise, High Fat Beverage
Study participant consumes a high fat beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.
|
Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max.
Subjects then sit quietly until the next meal.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Metabolic Flexibility by Room Calorimetry
Periodo de tiempo: 24 hours
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Participants will stay in a room calorimeter for 24 hours where oxygen consumed and carbon dioxide produced will be measured.
Mathematical approaches will use continuous calorimetry data to generate consistent estimates of the gas exchange rates, and hence accurate "instantaneous" respiratory exchange ratios.
This novel approach allows evaluating the instantaneous dynamics of respiratory quotient noninvasively and for many different conditions (e.g., exercise and various nutrient ratios).
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Continuous Glucose Monitoring
Periodo de tiempo: 24 hours
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Whole-day interstitial glucose profiles will be collected during each calorimeter measurement.
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24 hours
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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
1 de diciembre de 2012
Finalización primaria (Actual)
1 de septiembre de 2013
Finalización del estudio (Actual)
1 de septiembre de 2013
Fechas de registro del estudio
Enviado por primera vez
12 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
12 de noviembre de 2013
Publicado por primera vez (Estimar)
19 de noviembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
30 de mayo de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HS42
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. .