The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)
The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Berks
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Reading, Berks, Reino Unido, RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age: 20 - 49 years
- BMI 18.5 - 30 kg/m2
- Plasma glucose <7 mmol/l (Not diagnosed with diabetes)
- Plasma cholesterol <7 mmol/l
- Plasma TAG <2.3 mmol/l
- Normal liver and kidney function
- Haemoglobin (>110 g/l women; 140g/dl men)
Exclusion Criteria:
- Having suffered a myocardial infarction/stroke in the past 12 months
- diabetic (diagnosed or fasting glucose > 7 mmol/l)
- Smoking
- On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- Excessive alcohol consumption
- History of alcohol abuse
- Following a reducing diet or vegan diet
- Taking any fish oil, fatty acid or vitamin and mineral supplements
- Participating in intensive aerobic activity for > 20 minutes 3 times per week
- Food allergies
- Anti-inflammatory usage
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Reformulated products
Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks.
Subjects were provided with reformulated beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
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Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks.
Subjects were provided with reformulated beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
Otros nombres:
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Experimental: Conventional products
Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks.
Subjects were provided with conventional beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
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Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks.
Subjects were provided with conventional beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Changes in body weight and body composition
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in energy and nutrient intake
Periodo de tiempo: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in appetite and mood ratings
Periodo de tiempo: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Subjective sensations of appetite and mood by visual analogue scale
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in physical activity levels
Periodo de tiempo: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Measured by accelerometry
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in fasting plasma lipid, insulin and glucose concentrations
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Prof Julie A Lovegrove, BSc, PhD, RNutr, University of Reading
Publicaciones y enlaces útiles
Publicaciones Generales
- Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.
- Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 12/03
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