- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07692646
The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix (GlycoFast84)
The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix in Healthy Men and Lean and Obese Men and Women
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Four groups of young normal weight men (n=10) and women (n=10) and young obese men (n=10) and women (10) are recruited. After verbal and written information is provided signed consent is obtained.
Prior to the first day of the trial, the participants must complete a four-day dietary and exercise record based on the weighing of all food and beverages consumed and tracking all exercise. This is used to asses the participant's habitual diet and activity level. For female participants, an additional form must be completed regarding their menstrual cycle and form of contraception.
On the two trial days (before and after fasting), participants arrive at the laboratory in the morning, and on the first day, the participant will have fasted since the previous evening. Furthermore, participants have been asked to minimize strenous physical activity for 24 hours leading up to testing. Prior to day 1, participants have been instructed to consume a habitual carbohydrate-rich diet for the 48 hours preceding the first test day.
Initially, the participants' body composition is determined by DXA, after which the participants rest for 15 minutes. Subsequently, blood pressure is measured in the supine position whereafter resting energy expenditure is measured by indirect calorimetry. A venous blood sample is taken from the antecubital vein, as well as a biopsy from the m. vastus lateralis and from the subcutaneous abdominal adipose tissue using the Bergström technique applied with suction. After 30 minutes of rest, a graded exercise test on a cycle ergometer is initiated to determine peak fat oxidation and maximal oxygen uptake. After the test is completed and following a minimum of 10 minutes of rest, handgrip strength and knee extension strength are measured. This concludes the test day.
Thereafter, the 84-hour fast is initiated. During the fasting period, the subjects will communicate by telephone each morning with one of the researchers regarding their well-being and any questions they may have. On day 2 subjects will do 1 hour of submaximal exercise. During the fasting subjects will be provided with electrolyte tablets. Following the 84 hours, the subjects return to the laboratory. Here, the same protocol as described above is carried out. This concludes the test day and the experiment.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jørn W Helge, PhD
- Número de teléfono: +4528757506
- Correo electrónico: jhelge@sund.ku.dk
Ubicaciones de estudio
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Copenhagen, Dinamarca, 2200
- Reclutamiento
- Department of Biomedical Sciences
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Contacto:
- Jørn W Helge, PhD
- Número de teléfono: +4528757506
- Correo electrónico: jhelge@sund.ku.dk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Healthy normal weight men aged [18,40] and BMI [18,25]
- Healthy normal weight women [18,40] and BMI [18,25]
- Healthy obese men [18,40] and BMI [30,40]
- Healthy obese women [18,40] and BMI [30,40]
Exclusion Criteria:
- Present or former cardiovascular disease and chronical inflammatory disease
- Consumption of medications and supplements that influence substrate use at rest and/or during exercise
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Young normal weight men
BMI [18, 25] Age [18, 40]
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Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
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Experimental: Young normal weight women
BMI [18, 25] Age [18, 40]
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Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
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Experimental: Young obese men
BMI [30, 40] Age [18, 40]
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Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
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Experimental: Young obese women
BMI [30, 40] Age [18, 40]
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Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The effect of fasting and obesity on protein glycosylation of the extracellular matrix in adipose tissue
Periodo de tiempo: The fasting will last approximately 84 hours.
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The composition and protein glycosylation of the extracellular matrix will be measured in abdominal subcutaneous adipose tissue samples in 20 healthy normal weight men and women and 20 healthy obese men and women.
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The fasting will last approximately 84 hours.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The effect of fasting and obesity on peak fat oxidation
Periodo de tiempo: The fasting will last approximately 84 hours
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40 participants (20 healthy normal weight men and women and 20 healthy obese men and women) will fast for 84 hours.
Before and after the fast, peak fat oxidation (mg fat/min) is measured in an incremental bike test using indirect calorimetry.
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The fasting will last approximately 84 hours
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The effect of fasting and obesity on adipose tissue lipolytic capacity, muscle ketone oxidative capacity and mitochondrial coupling.
Periodo de tiempo: The fasting will last approximately 84 hours.
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The lipolytic capacity will be measured in abdominal subcutaneous adipose tissue samples and the capacity for ketone oxidation in vastus lateralis muscle in 20 healthy normal weight men and women and 20 healthy obese men and women.and
In addition mitochondrial respiratory capacity will be measured in the muscle and adipose biopsy samples using high-resolution respirometry (Oxygraphs, Oroboros).
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The fasting will last approximately 84 hours.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Comportamiento de alimentación
- Obesidad
- Ayuno
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Fenómenos fisiológicos nutricionales
- Dieta
Otros números de identificación del estudio
- Molecular Memory of Obesity
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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