- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03917810
Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured.
Each participant will undergo 3 days of each diet:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Descripción general del estudio
Descripción detallada
Guidelines calling for dietary free sugars to be reduced have been formulated from evidence that diets high in sugar are associated with high energy intake. In theory, by reducing the intake of sugars, calorie surplus will be reduced and energy balance will be maintained. However, when referring to interventions/behaviours that influence energy balance, both sides of the energy balance equation need to be considered. Alterations in nutrients may influence aspects of energy expenditure, not solely energy intake, and this may have implications for the efficacy of guidelines seeking to influence energy intake.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Furthermore, there is increasing interest in restricting overall carbohydrate intake to treat metabolic disease or achieve ketogenesis. Very little is known about nutrition-physical activity interactions with this type of intervention.
This study will prescribe 3 diets to healthy males for 3 days in a randomised crossover design, where each participant will consume each of the diets. All food will be prepared and provided by the study team. The diets are as follows:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Somerset
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Bath, Somerset, Reino Unido, BA2 7AY
- University of Bath
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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:
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Male
- Able and willing to provide informed consent and safely comply with study procedures
- No anticipated changes in physical activity during the study (e.g. holidays)
Exclusion Criteria:
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)•Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (±3%)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: MODSUG
Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat
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Se manipula la composición de macronutrientes (específicamente tipo y/o cantidad de carbohidratos)
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Experimental: LOWSUG
Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
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Se manipula la composición de macronutrientes (específicamente tipo y/o cantidad de carbohidratos)
|
|
Experimental: LOWCHO
Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat
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Se manipula la composición de macronutrientes (específicamente tipo y/o cantidad de carbohidratos)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical activity energy expenditure (kj/day or kcal/day)
Periodo de tiempo: 3 days
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Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)
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3 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time spent in different physical activity intensities (MET categories) (minutes)
Periodo de tiempo: 3 days
|
Time spent in different physical activity intensities (MET categories) (minutes) using individually-calibrated combined heart rate and accelerometry
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3 days
|
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Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
Periodo de tiempo: 3 days
|
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) using individually-calibrated combined heart rate and accelerometry
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3 days
|
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Energy expended in the postprandial period (kJ or kcal)
Periodo de tiempo: 3 days
|
Energy expended in the postprandial period (kJ or kcal) measured using individually-calibrated combined heart rate and accelerometry
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3 days
|
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Fasting blood glucose concentrations
Periodo de tiempo: 3 days
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Measures of blood glucose concentrations pre- and post-intervention.
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3 days
|
|
Fasting blood insulin concentrations
Periodo de tiempo: 3 days
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Measures of blood insulin concentrations pre- and post-intervention.
|
3 days
|
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Fasting blood triglyceride concentrations
Periodo de tiempo: 3 days
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Measures of blood triglyceride concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood non-esterified fatty acid concentrations
Periodo de tiempo: 3 days
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Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.
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3 days
|
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Fasting blood lactate concentrations
Periodo de tiempo: 3 days
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Measures of blood lactate concentrations pre- and post-intervention.
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3 days
|
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Fasting blood beta-hydroxybutyrate concentrations
Periodo de tiempo: 3 days
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Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood leptin concentrations
Periodo de tiempo: 3 days
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Measures of blood leptin concentrations pre- and post-intervention.
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3 days
|
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Fasting blood fibroblast growth factor-21 concentrations
Periodo de tiempo: 3 days
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Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.
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3 days
|
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Fasting blood total cholesterol concentrations
Periodo de tiempo: 3 days
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Measures of blood total cholesterol concentrations pre- and post-intervention.
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3 days
|
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Fasting blood high density lipoprotein concentrations
Periodo de tiempo: 3 days
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Measures of blood high density lipoprotein concentrations pre- and post-intervention.
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3 days
|
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Fasting blood low density lipoprotein concentrations
Periodo de tiempo: 3 days
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Measures of blood low density lipoprotein concentrations pre- and post-intervention.
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3 days
|
|
Food preference ratings
Periodo de tiempo: 3 days
|
Food preference ratings determined by computer task measured pre- and post-intervention
|
3 days
|
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Subjective appetite and mood ratings
Periodo de tiempo: 3 days
|
Measured by 0-100 mm visual analogue scales measured pre- and post-intervention
|
3 days
|
|
Blood pressure
Periodo de tiempo: 3 days
|
Blood pressure using an automated sphygmomanometer pre- and post-intervention
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3 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
- Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- EP 17/18 219
Información sobre medicamentos y dispositivos, documentos del estudio
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