- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00898599
Prebiotics and Immune Function in Middle Aged Humans
Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving the immune response. Inulin-type fructans (oligofructose and inulin) are classified as prebiotics. Inulin is found naturally in significant amounts in a variety of plants foods, such as bananas, leeks, onions, artichokes, wheat and chicory. Synergy1 is a prebiotic preparation produced by Beneo-Orafti, and containing a mixture of oligofructose and inulin derived from chicory. Fructooligosaccharides including Synergy1 are widely used by the food industry and are commonly found as a source of insoluble fibre in many biscuit, bakery, cereal and dairy products.
There is increasing evidence that the changes in the intestinal microflora that occur with the consumption of fructooligosaccharides can modulate immune parameters, not only in the gut-associated lymphoid tissue, but also secondary lymphoid tissues and the peripheral circulation. Much of the evidence for beneficial effects of fructooligosaccharides on immune function comes from animal models e.g. rats, mice, dogs and pigs. Results from these studies show that the innate and adaptive immune systems of both the gut associated lymphoid tissue and the systemic immune system can be modified by fructooligosaccharides. However, there are few human studies so far which have investigated the effects of prebiotics on immune function, and these studies mostly rely on systemic markers of immunity. The results show little effect of fructooligosaccharides on innate immune function, but mixed results are reported regarding the adaptive immune system, suggesting that there may by improvement on this aspect of immunity with increased intake of fructooligosaccharides. The small number of published human studies led Watzl et al. (2005) to suggest that more human studies are needed to find out whether inulin and/or oligofructose have the potential to modulate systemic immunity in well-nourished individuals.
There are numerous methods available for assessing the human immune response. These have been evaluated by a panel of European experts (Albers et al. 2005). Based on its biological relevance, sensitivity and practical feasibility, response to vaccination was identified by this panel as the gold standard for measuring the functioning of the immune system in vivo (Albers et al. 2005). A small number of studies have studied the effect of fructooligosaccharides on the human immune response using vaccination response as the outcome, but only four of these examined fructooligosaccharides in the absence of other additional nutrients and of these two studies were in infants. Thus, the number of studies examining the immunologic impact of fructooligosaccharides in adult humans and using the gold standard outcome is very limited. From a public health perspective, it would be of importance, if fructooligosaccharides can improve immune function especially in older adults who are at risk of age-related immune decline. Thus, we propose to use a commercially available influenza vaccine (Imuvac®) to stimulate the immune response in healthy human adults, and to use this to assess the effect of a well defined prebiotic preparation commonly used in the food industry (Synergy1).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Southampton, Reino Unido, SO16 6YD
- University of Southampton
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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:
- Aged 45-65 years
- Body mass index 20 to 32 kg/m2.
- Not consuming probiotic supplements, yoghurts, drinks or other foods
- Not consuming prebiotic supplemented drinks or foods
- In general good health
- No antibiotic use in the 2 months prior to entering the study or during the study
- Not been vaccinated with the current season's influenza vaccine
- Being able to provide written informed consent
Exclusion Criteria:
- Aged < 45 or > 66 years
- Body mass index < 20 or > 32 kg/m2.
- Being diabetic (type 1 or type 2)
- Displaying manifestations of allergy - asthma, hay-fever, dermatitis - or being treated for these
- Being egg allergic
- Use of any prescribed medicine (unless deemed to be acceptable by the PI)
- Suffering from any infectious illness
- Chronic gastrointestinal problems (e.g. IBD, IBS, cancer)
- Recent blood donation
- Participation in another clinical trial
- Use of prebiotic or probiotic supplements, foods or drinks
- Consuming vitamin, mineral or oil supplements
- Previously vaccinated with the influenza vaccine being used.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Maltodextrina
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Maltodextrina como placebo
Otros nombres:
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Experimental: Prebiotic
Inulin type fructooligosaccharides
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Inulin type fructooligosaccharides
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Serum anti-vaccine antibody concentrations
Periodo de tiempo: Weeks 2 and 4 post-vaccination
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Weeks 2 and 4 post-vaccination
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Serum total antibody (IgG, IgA, IgM) concentrations
Periodo de tiempo: Weeks -4, 0, 2 and 4 with respect to vaccination
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Weeks -4, 0, 2 and 4 with respect to vaccination
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Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst
Periodo de tiempo: Weeks -4, 0, 2 and 4 with respect to vaccination
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Weeks -4, 0, 2 and 4 with respect to vaccination
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Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)
Periodo de tiempo: Weeks -4, 0, 2 and 4 with respect to vaccination
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Weeks -4, 0, 2 and 4 with respect to vaccination
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Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)
Periodo de tiempo: Weeks 0, 2 and 4 with respect to vaccination
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Weeks 0, 2 and 4 with respect to vaccination
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Ex vivo natural killer cell activity
Periodo de tiempo: Weeks -4, 0, 2 and 4 with respect to vaccination
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Weeks -4, 0, 2 and 4 with respect to vaccination
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Faecal microflora
Periodo de tiempo: Weeks -4 and 0 with respect to vaccination
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Weeks -4 and 0 with respect to vaccination
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Salivary IgA concentration
Periodo de tiempo: Weeks -4, 0, 2 and 4 with respect to vaccination
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Weeks -4, 0, 2 and 4 with respect to vaccination
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Philip C Calder, PhD, University of Southampton
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
Otros números de identificación del estudio
- RHMNUT0055
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