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The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)

3 de diciembre de 2014 actualizado por: Julie Lovegrove, University of Reading

The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations

Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake. Reformulating processed foods (e.g. sugary products) is considered one of the key options for improving population diet. The implications of regular consumption of reformulated products are not fully understood. Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated. In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance. However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population. It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Reino Unido
    • Berks
      • Reading, Berks, Reino Unido, RG6 6AP
        • Department of Food and Nutritional Sciences, University of Reading

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 49 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Suplemento dietético: 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.
Otros nombres:
  • REF
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.
Suplemento dietético: 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.
Otros nombres:
  • ESTAFA

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Changes in body weight and body composition
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
20 weeks. Baseline and week 8 assessments for two dietary intervention arms

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in energy and nutrient intake
Periodo de tiempo: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in appetite and mood ratings
Periodo de tiempo: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Subjective sensations of appetite and mood by visual analogue scale
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in physical activity levels
Periodo de tiempo: 20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Measured by accelerometry
20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
Changes in fasting plasma lipid, insulin and glucose concentrations
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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
20 weeks. Baseline and week 8 assessments for two dietary intervention arms
Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
Periodo de tiempo: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
20 weeks. Baseline and week 8 assessments for two dietary intervention arms

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Reading

Investigadores

  • Investigador principal: Prof Julie A Lovegrove, BSc, PhD, RNutr, University of Reading

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2012

Finalización primaria (Actual)

1 de marzo de 2013

Finalización del estudio (Actual)

1 de marzo de 2013

Fechas de registro del estudio

Enviado por primera vez

18 de julio de 2012

Primero enviado que cumplió con los criterios de control de calidad

18 de julio de 2012

Publicado por primera vez (Estimar)

20 de julio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de diciembre de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

3 de diciembre de 2014

Última verificación

1 de diciembre de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 12/03

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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