- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03531398
Postprandial Responses to Typical UK Meal Nutrient Profiles (Pre-PREDICT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Dietary fat consumption is one of the major modifiable risk factors implicated in the causation of cardiovascular disease (CVD). Postprandial lipaemia (PPL); the increase in circulating blood triacylglycerol (TAG) concentrations after a fat containing meal, is an independent risk factor for cardiovascular disease. However, little is known about how different doses of fats as found in typical UK meals will influence the level of PPL.
The majority of research into PPL, including work by our own group and others has largely focused on the postprandial effect following high fat meals, with the primary goal of assessing mechanisms underlying fat metabolism. However, these findings are not relevant from a public health perspective; in reality the average fat content of a meal is much lower than this (~20- 30 g fat, (NDNS, 2013/4)); therefore it is important to assess the impact of doses of fat in this range on PPL to be relevant to public health. The few dose response studies that have been performed assessing fat load and PPL have used liquid test meals that are not relevant to every day meals.
PPL is usually measured by taking a series of blood samples from a cannula, however this is an invasive procedure. There has been an increase in the development of less invasive biochemical assessment, e.g. urine or saliva analysis or dried blood spot (DBS) analysis. DBS analysis is particularly advantageous as samples can be easily collected by the individual under assessment with minimal equipment and transferred easily for analysis via the post, providing simple home-testing. Frequently, postprandial research studies will draw blood from the cannula for multiple related outcomes and therefore, performing multiple assays from one DBS sample would be advantageous in minimizing participant discomfort.
Aim: The primary aim of the current study is to investigate the postprandial response following typical UK meal nutrient profiles containing 20-30g fat. Secondary aims will be to test the feasibility for measuring PPL, insulin, c-peptide and performing metabolomic analysis from DBS versus serum blood analysis. Further, it will assess the best practice for collection (venous versus finger prick) and storage (ambient versus freezer) of the DBS samples.
Hypothesis: Typical UK meal nutrient profiles will elicit detectable PPL. Further, DBS will be an effective method for measuring postprandial outcomes.
Expected value: The study will provide novel information on the effect of fat doses from typical UK meals on PPL. It will also provide feasibility for using DBS for measuring postprandial responses.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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UK
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London, UK, Reino Unido, SE1 9NH
- King's College London
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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:
- Males and females aged 18-65 years.
- Free of diagnosed diseases listed in exclusion criteria.
- Able to understand the information sheet and willing to comply with study protocol.
- Able to give informed consent.
Exclusion Criteria:
Refuse or are unable to give informed consent to participate in the study
- BMI >32 kg/m2
- BP >170/100 mm Hg
- Have had long term inflammatory disease or cancer in the last three years.
- Have had long term gastrointestinal disorders including inflammatory bowel disease (IBD) or Coeliac disease (gluten allergy).
- Are taking the following daily medications: immunosuppressants, antibiotics in the last three months
- Are long-term users of PPIs, unless they are able to stop two weeks before the start of the study.
- Have type I diabetes mellitus or type II diabetes mellitus.
- Are currently suffering from acute clinically diagnosed depression.
- Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
- Are pregnant
- Are vegan, suffering from an eating disorder or unwilling to take foods that are part of the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: High fat meal
Muffin containing 30g fat
|
Metabolic test meal challenge
|
|
Experimental: Medium fat meal
Muffin containing 20g fat
|
Metabolic test meal challenge
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postprandial lipaemia
Periodo de tiempo: 0-4 hours postprandially
|
Change in serum triglycerides
|
0-4 hours postprandially
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postprandial glycaemia
Periodo de tiempo: 0-4 hours postprandially
|
Change in plasma glucose
|
0-4 hours postprandially
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postprandial plasma insulin
Periodo de tiempo: 0-4 hours postprandially
|
Change in plasma insulin
|
0-4 hours postprandially
|
|
Postprandial plasma c-peptide
Periodo de tiempo: 0-4 hours postprandially
|
Change in plasma C-peptide
|
0-4 hours postprandially
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- HR-17/18-5652
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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