- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07610759
Inter-Individual Variability in Early Diet-Induced Thermogenesis After a Standardized Meal
Inter-Individual Variability in Early Postprandial Thermogenesis Following a Standardized Liquid Meal
This study aims to characterize how individuals differ in their metabolic response to food intake, specifically focusing on early diet-induced thermogenesis (DIT). DIT refers to the increase in energy expenditure that occurs after eating and reflects the body's metabolic response to processing nutrients.
Healthy adult participants will complete a single laboratory visit under standardized conditions. Resting metabolic rate will first be measured, followed by consumption of a standardized liquid meal (550 kcal). Energy expenditure will then be continuously monitored for 3 hours using indirect calorimetry.
The primary objective is to quantify inter-individual variability in early postprandial thermogenesis. Rather than estimating total daily energy expenditure, this study focuses on the early metabolic response following meal ingestion. Findings will improve understanding of differences in metabolic efficiency between individuals and support future research in metabolism and personalized nutrition.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diet-induced thermogenesis (DIT) represents the increase in energy expenditure above resting levels following food intake and reflects the energetic costs of digestion, absorption, transport, and metabolism of nutrients. Although DIT typically accounts for a relatively small proportion of total daily energy expenditure, it plays an important role in postprandial metabolism and may contribute to inter-individual differences in energy balance and body weight regulation.
Most prior research has focused on estimating total DIT over prolonged postprandial periods (e.g., 4-6 hours or longer). However, these approaches may obscure meaningful variability in the early phase of the thermogenic response, which is characterized by rapid and dynamic metabolic changes. The most pronounced increase in energy expenditure typically occurs within the first 1-3 hours following meal ingestion, driven by early physiological processes including gastrointestinal activity and neuroendocrine responses.
Emerging evidence suggests that individuals vary substantially in their metabolic response to a standardized meal, even under controlled conditions. However, this variability is often averaged out in group-level analyses or diluted by long measurement windows. The present study is specifically designed to characterize observed inter-individual variability in early DIT, rather than to estimate total thermogenesis or test intervention effects.
This study is a controlled, cross-sectional physiological study in healthy adults. Each participant will complete a single study visit under standardized laboratory conditions. After an initial resting period, resting metabolic rate will be measured using indirect calorimetry. Participants will then consume a standardized liquid meal providing 550 kcal, after which energy expenditure will be continuously monitored for 180 minutes.
Strict pre-test standardization procedures (including fasting, avoidance of exercise, caffeine, and alcohol) will be implemented to minimize non-biological variability. Body composition will also be assessed to support interpretation of metabolic responses.
The primary outcome is early DIT, quantified as the increase in energy expenditure above baseline over the postprandial period. Secondary analyses will describe the distribution, magnitude, and temporal characteristics of the thermogenic response, including peak response and time to peak.
By focusing on the early postprandial phase, this study aims to provide detailed characterization of variability in metabolic responses under tightly controlled conditions. These findings will contribute to a better understanding of human metabolic heterogeneity and may inform future research in metabolic physiology, obesity, and personalized nutrition.
Although a standardized liquid meal is administered as part of the protocol, the study is designed to characterize physiological variability in metabolic response rather than to evaluate the effect of an intervention.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yftach Prof. Gepner
- Número de teléfono: 0506828501
- Correo electrónico: gepner@tauex.tau.ac.il
Copia de seguridad de contactos de estudio
- Nombre: Lien Bruck
- Número de teléfono: 0587487431
- Correo electrónico: lienbruck@tauex.tau.ac.il
Ubicaciones de estudio
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Tel Aviv, Israel, 6428607
- Sylvan Adams Sport Science Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged ≥18 years
- Stable body weight (±2 kg over the previous 3 months)
- Generally healthy individuals
- Ability to comply with study procedures, including fasting and remaining at rest - during measurements
Exclusion Criteria:
- Use of medications known to affect metabolism (e.g., GLP-1 receptor agonists, systemic corticosteroids, uncontrolled thyroid disease)
- Insulin-treated diabetes
- Pregnancy or lactation
- Acute illness at the time of testing
- Inability to comply with pre-test requirements (e.g., fasting, avoiding caffeine, alcohol, or physical activity)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Healthy Adult Participants
Healthy adults (≥18 years) participating in a single laboratory visit.
All participants undergo resting metabolic rate assessment, consume a standardized liquid meal (550 kcal), and complete continuous postprandial energy expenditure measurement using indirect calorimetry under controlled conditions.
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Consumption of a standardized liquid meal (~550 kcal) under controlled laboratory conditions, followed by continuous measurement of energy expenditure using indirect calorimetry for assessment of postprandial thermogenesis.
The procedure is used for measurement purposes only and is not intended as a therapeutic intervention.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Early Diet-Induced Thermogenesis Area Under the Curve
Periodo de tiempo: From meal completion to 180 minutes post-meal
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Area under the curve for diet-induced thermogenesis over 180 minutes after consumption of the standardized liquid meal.
DIT will be calculated as postprandial energy expenditure minus baseline resting energy expenditure and expressed as kcal/180 min.
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From meal completion to 180 minutes post-meal
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Diet-Induced Thermogenesis
Periodo de tiempo: From meal completion to 180 minutes post-meal
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Mean increase in energy expenditure above baseline resting energy expenditure during the 180-minute postprandial measurement period, expressed as kcal/min or kcal/180 min.
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From meal completion to 180 minutes post-meal
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Peak Diet-Induced Thermogenesis
Periodo de tiempo: From meal completion to 180 minutes post-meal
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Maximum increase in energy expenditure above baseline resting energy expenditure observed during the 180-minute postprandial measurement period, expressed as kcal/min.
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From meal completion to 180 minutes post-meal
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Time to Peak Diet-Induced Thermogenesis
Periodo de tiempo: Time from completion of the standardized liquid meal to the maximum observed increase in energy expenditure, expressed in minutes.
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From meal completion to 180 minutes post-meal
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Time from completion of the standardized liquid meal to the maximum observed increase in energy expenditure, expressed in minutes.
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Percent Increase in Energy Expenditure Above Baseline
Periodo de tiempo: From meal completion to 180 minutes post-meal
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Percentage increase in postprandial energy expenditure above baseline resting energy expenditure during the 180-minute measurement period.
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From meal completion to 180 minutes post-meal
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Fat-Free Mass-Normalized Diet-Induced Thermogenesis
Periodo de tiempo: From meal completion to 180 minutes post-meal
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Diet-induced thermogenesis area under the curve normalized to fat-free mass, expressed as kcal/180 min/kg fat-free mass.
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From meal completion to 180 minutes post-meal
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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
Otros números de identificación del estudio
- 0012144-1
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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