Acute Effects of MCT Formulations on Beta-Hydroxybutyrate Response, Lipid Profile, and Glucose Levels in Healthy Adults
Acute Effects of Different Medium-Chain Triglyceride (MCT) Formulations on Ketone Body Production, Plasma Lipid Profile, and Glucose Levels in Healthy Adults: a Randomized Crossover Study
The goal of this clinical trial is to evaluate the effects of medium-chain triglycerides (MCTs), delivered in different formulations, on beta-hydroxybutyrate response (as a marker of ketone body production), lipid metabolism, and glucose responses in healthy adults.
The main questions it aims to answer are:
Do MCTs influence beta-hydroxybutyrate responses, lipid metabolism, and glucose responses differently compared to long-chain triglycerides (LCTs)?
Do different types of MCTs (natural sources containing C8 to C12 versus synthetic formulations containing only C8 and C10) lead to different beta-hydroxybutyrate, lipid, and glucose responses?
Does the form in which MCTs are consumed (e.g., powders or incorporated into foods) influence beta-hydroxybutyrate production, lipid metabolism, and glucose responses?
Researchers will compare five different lipid formulations to evaluate their effects on postprandial beta-hydroxybutyrate concentrations, blood lipid levels, and glucose.
Participants will:
Consume five different test products on separate study visits. Provide blood samples for up to five hours after each intake for metabolic measurements.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This randomized crossover study is designed to evaluate the metabolic effects of five different lipid-based formulations in healthy adults. Medium-chain triglycerides (MCTs) are known to be rapidly absorbed and metabolized, promoting the production of ketone bodies, which can serve as an alternative energy source. However, metabolic responses to MCTs may vary depending on their fatty acid composition and the form in which they are consumed.
The study compares different lipid formulations, including long-chain triglycerides (LCTs), synthetic MCTs composed of C8 and C10 fatty acids, and MCTs derived from natural sources such as coconut oil (containing C8 to C12 fatty acids). In addition, the study evaluates the impact of the food matrix by comparing similar lipid compositions provided in different forms, including reconstituted powders and a solid food product.
Participants attend multiple study visits after an overnight fast and consume each test product in a randomized order. The amount of each product is adjusted to provide a standardized lipid dose of 0.5 g/kg of body weight, and a washout period of at least 7 days is applied between visits.
During each visit, blood samples are collected over a period of up to 5 hours after product consumption. Primary metabolic outcomes include postprandial beta-hydroxybutyrate concentrations (as a marker of ketone body production), glucose response, and triglyceride response. Secondary outcomes include circulating fatty acid profiles, ghrelin concentrations, and subjective appetite ratings assessed using visual analogue scales.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alessandro Leone
- Número de teléfono: 00390250316652
- Correo electrónico: alessandro.leone1@unimi.it
Ubicaciones de estudio
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Milan, Italia, 20133
- Reclutamiento
- International Center for the Assessment of Nutritional Status and the development of Dietary Intervention Strategies (ICANS-DIS), Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan
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Contacto:
- Alessandro Leone, Prof
- Número de teléfono: 00390250316652
- Correo electrónico: alessandro.leone1@unimi.it
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Sub-Investigador:
- Alessandro Leone, Prof
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Investigador principal:
- Simona Bertoli, Prof
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Healthy adult participants
- Age between 18 and 40 years
- Ability to understand the study procedures and provide informed consent
Exclusion Criteria:
- Alterations in glucose or lipid metabolism
- Diseases requiring the use of medications that affect glucose or lipid metabolism
- Reported or diagnosed malabsorption conditions
- Pregnancy or breastfeeding
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: All Interventions (Crossover)
Participants receive all five test products in a randomized crossover design.
The order of administration is randomized, and each product is provided in an amount adjusted to deliver a standardized lipid dose of 0.5 g/kg of body weight.
A washout period of at least 7 days is applied between interventions.
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Beverage containing medium-chain triglycerides (MCTs).
Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
Beverage containing long-chain triglycerides (LCTs).
Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
Powder formulation containing synthetic medium-chain triglycerides (MCTs) composed of C8 and C10 fatty acids, reconstituted in water before consumption.
Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
Powder formulation containing medium-chain triglycerides (MCTs) derived from coconut oil (containing fatty acids from C8 to C12), reconstituted in water before consumption.
Administered to provide a lipid dose of 0.5 g/kg of body weight
Biscuit containing medium-chain triglycerides (MCTs) derived from coconut oil.
Administered in a quantity adjusted to provide a lipid dose of 0.5 g/kg of body weight.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Beta-hydroxybutyrate postprandial response
Periodo de tiempo: Up to 300 minutes post-ingestion
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Beta-hydroxybutyrate concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time
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Up to 300 minutes post-ingestion
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Glucose postprandial response
Periodo de tiempo: Up to 300 minutes post-ingestion
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Serum glucose concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time.
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Up to 300 minutes post-ingestion
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Triglyceride postprandial response
Periodo de tiempo: Up to 300 minutes post-ingestion
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Serum triglyceride concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product to assess the metabolic response over time.
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Up to 300 minutes post-ingestion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fatty Acid Postprandial Response
Periodo de tiempo: Up to 300 minutes post-ingestion
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Serum fatty acid concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product.
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Up to 300 minutes post-ingestion
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Ghrelin postprandial response
Periodo de tiempo: Up to 300 minutes post-ingestion
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Blood ghrelin concentrations measured at baseline and at 30, 60, 90, 120, 180, 240, and 300 minutes after consumption of each test product.
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Up to 300 minutes post-ingestion
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Subjective appetite ratings (VAS)
Periodo de tiempo: Up to 300 minutes post-ingestion
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Subjective appetite assessed using visual analogue scales (VAS) at baseline, immediately after product consumption, and at 30, 60, 90, 120, 180, 240, and 300 minutes post-ingestion.
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Up to 300 minutes post-ingestion
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
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
Otros números de identificación del estudio
- 101/25
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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