- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02215603
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fabiana Benatti
- Número de teléfono: +45 35450898
- Correo electrónico: fabiana.braga.benatti@regionh.dk
Ubicaciones de estudio
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Copenhagen, Dinamarca, 2100
- Reclutamiento
- Centre of Inflammation and Metabolism
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Contacto:
- Inge Holm
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Investigador principal:
- Bente Pedersen, PhD
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Sub-Investigador:
- Fabiana Benatti, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Males,
- age 25-55 y,
- BMI >18 and <35 kg/m2
Exclusion Criteria:
- Clinically diagnosed diabetes,
- dyslipidaemia,
- hypertension,
- use of glucose- and/or lipid-lowering medication,
- smoking,
- evidence of thyroid, liver, lung, heart or kidney disease,
- non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,
- VO2max levels above the considered average fitness according to age,
- contraindication to increased levels of physical activity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Prolonged sitting
9 h of prolonged sitting
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Experimental: Prolonged sitting + interval standing bouts
Stand bout for 15-min every 30 minutes during the 9 hours of sitting
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Experimental: Moderate exercise bout + Prolonged sitting
30-min moderate-intensity exercise bout followed by 8 h of sitting
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Experimental: Moderate exercise bout + Prolonged sitting +Standing bouts
30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Area under the curve of glucose and insulin postprandial responses
Periodo de tiempo: 27 h
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Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Glucose levels
Periodo de tiempo: 27 hours
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Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours.
Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).
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27 hours
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Area under the curve of lipid postprandial responses
Periodo de tiempo: 27 h
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Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Area under the curve of cytokine postprandial responses
Periodo de tiempo: 27 h
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Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal.
These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
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27 h
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- ProlongedSitting
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