- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07229963
Intensidad del Ejercicio y Efectos Postprandiales de Romper el Comportamiento Sedentario en Adultos con Sobrepeso
Efectos Cardiometabólicos Postprandiales de Interrumpir el Comportamiento Sedentario con Ejercicio de Diferente Intensidad en Adultos Sanos con Sobrepeso
The purpose of this study is twofold: (1) to determine whether breaking up prolonged sitting with aerobic or sprint cycling breaks reduces postprandial blood glucose, insulin, CRP, and blood pressure, which are established risk markers for cardiometabolic diseases; and (2) to assess substrate oxidation during this period in order to identify which exercise condition promotes the greatest increase in fat oxidation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sedentary behavior (SED) refers to activities such as sitting, lying down, or reclining that require energy expenditure of ≤1.5 MET during the time spent awake. Prolonged and continuous sedentary behavior leads to adverse effects such as abnormal postprandial metabolic responses, insulin resistance, vascular dysfunction, high blood pressure, increased carbohydrate oxidation, and inflammation. Epidemiological data also show that SED increases the risk of mortality, cardiovascular disease, type 2 diabetes, and certain types of cancer. Experimental studies have shown that 2-5 minutes of low- or moderate-intensity aerobic exercise performed every 20-30 minutes during the postprandial period improves cardiometabolic health by reducing glucose, insulin, and blood pressure during the postprandial period. On the other hand, it is known that short-term sprint interval exercise (SIE) increases insulin sensitivity by rapidly depleting muscle glycogen, improves glucose control, lowers blood pressure, and increases fat oxidation. With these effects, SIE may be a time-efficient method for interrupting SED. Although the cardiometabolic benefits of SIE and aerobic exercise interruptions (AEI) are known, there is a lack of studies comparing the effects of interrupting SED with these two exercise types of different intensities in preventing postprandial cardiometabolic dysfunction. In this context, the aim of the study is to compare the postprandial cardiometabolic effects of interrupting sedentary behavior with AIE and sprint exercise interruptions (SEI) in overweight but otherwise healthy women and men aged 30-45. In this randomized crossover trial, volunteers will participate in three trials: 1) AEI, 2) SEI, and 3) SED. There will be a minimum 4-day washout period between trials. In the SEI and AEI trials, exercise interruptions will be implemented every 30 minutes during the 7-hour sitting period, whereas in the SED trial, participants will remain seated continuously for the entire duration. In all conditions, two meals (breakfast and lunch) will be served 3 hours apart, and the trials will begin, after the breakfast meal is consumed. Venous blood samples for every 30 minutes of the first two hours following meals to measure glucose and to be taken hourly during the rest experiment will be used to analyze insulin, glucose, and C-reactive protein (CRP) levels. In addition, blood pressure will be measured hourly, and fat oxidation will be assessed at the baseline, 2nd, 5th, and 7th hours. The effects of the conditions on glucose and insulin will be evaluated using linear mixed models. A Two-Way (Trial x Number of Repeats) Analysis of Variance for Repeated Measures will be used to detect differences between conditions.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hikmet Sercan Toprakoğlu
- Número de teléfono: +905369792652
- Correo electrónico: sercantprkgl@gmail.com
Ubicaciones de estudio
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Beytepe
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Ankara, Beytepe, Turquía (Türkiye)
- Reclutamiento
- Hacettepe Sports Science Faculty, Hacettepe Beytepe Clinic
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Contacto:
- Şükran Nazan Koşar, Professor
- Número de teléfono: 0538 861 29 24
- Correo electrónico: nazankosar@gmail.com
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Investigador principal:
- Hikmet Sercan Toprakoğlu
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Sub-Investigador:
- Seda Hanife Oğuz Baykal, Associate Professor
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Sub-Investigador:
- Muhammed Mustafa Atakan, Associate Professor
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Sub-Investigador:
- Yasemin Güzel, Doctoral faculty member
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Sub-Investigador:
- Yiğitcan Karanfil, Doctoral faculty member
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Sub-Investigador:
- İbrahim Türkel, Doctoral faculty member
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Sub-Investigador:
- Şükran Nazan Koşar, Professor
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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
- Being physically inactive (not doing at least 150 minutes/week of structured exercise).
- Being sedentary (having a daily sedentary time/day for >7 hours).
- Having a BMI between 25 and 29.9 kg/m2.
- Having a history of regular menstrual cycles for female participants.
- Having medical examination approval.
Exclusion Criteria
- Taking any acute or chronic medication or supplement that may affect metabolism.
- Having an acute or chronic illness that limits exercise (musculoskeletal problems, cardiovascular disorders, respiratory problems, etc.).
- Consuming tobacco products.
- Meeting 3 or more of the metabolic syndrome criteria (waist circumference of 102 cm or more in men, 88 cm or more in women, triglyceride level of 150 mg/dL or higher, HDL cholesterol level below 40 mg/dL in men and 50 mg/dL in women, blood pressure of 130/85 mmHg or higher, fasting blood glucose level of 100 mg/dL (5.6 mg/L) or higher).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Sedentary: Participants will remain seated for 7 h.
The sedentary condition will take place in a seated position. During the seated condition, volunteers will be seated at a typical desk chair at an appropriate height with hip and knee angles of ~90° and feet flat on the floor. The seating area will include a standard desk chair, a work desk, and the volunteers' personal laptops. Volunteers will be instructed prior to the visit to avoid behaviors such as fidgeting, excessive leg movements, and crossing their legs to minimize potential extraneous effects. |
Participants will remain seated for a total duration of 7 hours. During this period, they will be instructed to minimize excessive movement and will only be permitted to rise from the chair for voiding purposes. |
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Experimental: Breaking up sitting with aerobic exercise interruptions
The protocol that will interrupt sitting with AEI will involve cycle exercises performed at 50% of Wattmax for 2 minutes. The W and rpm levels corresponding to 50% of Wattmax will be determined using the values recorded during the determination of Wattmax. |
In the aerobic exercise condition, participants will perform 2 minutes of moderate-intensity (%50 Wattmax) continuous cycling. |
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Experimental: Breaking up sitting with sprint exercise interruptions
The protocol that will interrupt sitting with SEI will involve cycle exercises performed at the maximum revolutions per minute achievable within 10 seconds. Immediately (2-3 seconds) before each SEI, volunteers will increase their pedal cadence to the maximum speed they can achieve, after which a pedal load will be applied to the bicycle ergometer and a sprint will be performed against the applied load for 10 seconds. During each sprint, the pedal load will be applied at %200 Wattmax level. |
In the sprint condition, participants will complete a 10-second sprint at %200 Wattmax level, as determined during the preliminary test. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Insulin
Periodo de tiempo: 7 hour for each experimental condition
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Postprandial insulin. Net incremental area under the curve and total area under the curve for each 7 h condition will be calculated for insulin. |
7 hour for each experimental condition
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Glucose
Periodo de tiempo: 7 hour for each experimental condition
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Postprandial glucose. Net incremental area under the curve and total area under the curve for each 7 hour condition will be calculated for glucose. |
7 hour for each experimental condition
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CRP
Periodo de tiempo: 7 hour
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Postprandial CRP. Net incremental area under the curve and total area under the curve for each 7 h condition will be calculated for CRP. |
7 hour
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Substrate oxidation
Periodo de tiempo: 0, 2th, 5th, 7th hours
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Postprandial substrate oxidation. During each experimental visit, for 7 hours, volunteers' respiratory data will be collected using a direct calorimeter with canopy hood in lying position for 10 minutes at 0, 2th, 5th, and 7th hours. The volunteers' resting fat and carbohydrate oxidations will be determined from the obtained data. |
0, 2th, 5th, 7th hours
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Blood pressure
Periodo de tiempo: 7 hour
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Postprandial arterial blood pressure will be measured hourly for 7 h using an automatic blood pressure monitor with a cuff of appropriate size. The systolic and diastolic BP values measured will be recorded, and the mean arterial pressure will be calculated. |
7 hour
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Şükran Nazan Koşar, Professor, Hacettepe University
Publicaciones y enlaces útiles
Publicaciones Generales
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Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SBA 25/679
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
We do not plan to share IPD with other researchers due to privacy concerns and ethical restrictions outlined in the study's informed consent procedure.
Información sobre medicamentos y dispositivos, documentos del estudio
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