- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02169661
Burger and Beetroot Study - Lipid Oxidation Study (BABS)
Lipid Oxidation of Ready Meals: Reformulation With Antioxidant Phytochemicals
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Many of these lipid oxidation products such as malondialdehyde are known to be genotoxic and potentially detrimental to health. Consequently the aim of this study is to assess whether consumption of "ready meals" rich in certain fats leads to a post-prandial increase in lipid oxidation products in plasma and whether this can be ameliorated by reformulating the meals with natural extracts rich in phytochemicals with potential antioxidant activity in the stomach.
Diet design requirements:
The basic "ready meal" is a turkey burger consisting of
- 50% fat
- 20% protein
- 30% carbohydrate.
However, there are four experimental forms of the burger.
- The fat is unsaturated (stripped corn oil)
- The fat is saturated (lard)
- The fat is unsaturated and the diet also contains a beetroot extract at a concentration of 10g/100g.
- The fat is saturated and the diet also contains a beetroot extract at a concentration of 10g/100g.
Beetroot (http://www.kanegrade.com/powders.htm) has been selected for the burger reformulation as it is a Scottish product rich in phytochemicals with potential antioxidant efficacy. An additional benefit may a blood pressure lowering effect. Initial taste tests indicate acceptable palatability.
All other components of the burger are formulated to be as similar as possible.
Fatty acid profiles and the "basic eight" used on food labels will be determined on the diets. Susceptibility of the diets to oxidise will be assessed using RANCIMAT.
Ready Meal Intervention:
This will be a latin square format whereby each volunteer consumes 4 treatments on separate occasions. This is a powerful design to assess whether incorporation of phytochemicals from Scottish products improves the health benefits of processed food as each volunteer acts as his/her own control. Volunteers will be randomly allocated to four groups
- Treatment A High polyunsaturated (PUFA) ready meal (ie. burger)
- Treatment B High saturated (SFA) fat ready meal
- Treatment C High PUFA ready meal incorporating food extract
- Treatment D High SFA ready meal incorporating food extract
There will be a washout period of at least 7 days between each treatment.
Volunteers:
Healthy volunteers aged 21 to 60 years will be recruited and attend HNU having fasted from 22.00h the previous evening on four test days. On arrival, they will be asked to provide a urine sample. The volunteers will then have a cannula inserted by a trained nurse and an initial baseline blood sample will be taken (volume 10 ml). The subjects will then be asked to consume the assigned breakfast within a 15 minute period. Water will be provided. Volunteers will then be requested to provide 10ml blood samples at 1h, 2h, 4h and 6h and 24 hrs. A 24 hr urine sample also will be obtained, starting the day of the test day. Blood pressure will be recorded at each time point.
Volunteers will not be included if they
- Are taking any medicines prescribed by their GP
- Have a known allergy to beetroot
- Are vegetarian or vegan
- Regularly take nutritional supplements
- Have given a large blood donation in last three months
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Scotland
-
Aberdeen, Scotland, Reino Unido, AB21 9SB
- Human Nutrition Unit, Rowett Institute of Nutrition and Health
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- No diagnosed clinical condition
Exclusion Criteria:
Are taking any medicines prescribed by their GP Have a known allergy to beetroot Are vegan Regularly take nutritional supplements Have given a large blood donation in last three months
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Burger and Beetroot Study
|
50% fat, 10% beetroot extract
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Lipid peroxides
Periodo de tiempo: up to 24 hours
|
Indices of oxidised lipids in plasma
|
up to 24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Blood pressure
Periodo de tiempo: up to 24 hours
|
Systolic and diastolic blood pressure
|
up to 24 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Garry G Duthie, PhD, University of Aberdeen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- HNU 2000
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