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Prebiotics and Immune Function in Middle Aged Humans

Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults

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 immune function. There are numerous methods available for assessing the human immune response. Response to vaccination is thought to be a good method for this. Not many studies have examined the effect of prebiotics on the human immune response to vaccination. Thus the investigators propose to test the effect of a prebiotic on the immune response in healthy volunteers including their response to the current flu vaccine. The investigators hypothesise that the prebiotic will enhance the immune response including the response to the vaccine.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

49

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Southampton, Regno Unito, SO16 6YD
        • University of Southampton

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 45 anni a 66 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Aged 45-65 years
  2. Body mass index 20 to 32 kg/m2.
  3. Not consuming probiotic supplements, yoghurts, drinks or other foods
  4. Not consuming prebiotic supplemented drinks or foods
  5. In general good health
  6. No antibiotic use in the 2 months prior to entering the study or during the study
  7. Not been vaccinated with the current season's influenza vaccine
  8. Being able to provide written informed consent

Exclusion Criteria:

  1. Aged < 45 or > 66 years
  2. Body mass index < 20 or > 32 kg/m2.
  3. Being diabetic (type 1 or type 2)
  4. Displaying manifestations of allergy - asthma, hay-fever, dermatitis - or being treated for these
  5. Being egg allergic
  6. Use of any prescribed medicine (unless deemed to be acceptable by the PI)
  7. Suffering from any infectious illness
  8. Chronic gastrointestinal problems (e.g. IBD, IBS, cancer)
  9. Recent blood donation
  10. Participation in another clinical trial
  11. Use of prebiotic or probiotic supplements, foods or drinks
  12. Consuming vitamin, mineral or oil supplements
  13. Previously vaccinated with the influenza vaccine being used.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Maltodestrina
Maltodestrina come placebo
Altri nomi:
  • Maltodestrina
Sperimentale: Prebiotic
Inulin type fructooligosaccharides
Inulin type fructooligosaccharides
Altri nomi:
  • Sinergia1

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Serum anti-vaccine antibody concentrations
Lasso di tempo: Weeks 2 and 4 post-vaccination
Weeks 2 and 4 post-vaccination

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Serum total antibody (IgG, IgA, IgM) concentrations
Lasso di tempo: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst
Lasso di tempo: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)
Lasso di tempo: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)
Lasso di tempo: Weeks 0, 2 and 4 with respect to vaccination
Weeks 0, 2 and 4 with respect to vaccination
Ex vivo natural killer cell activity
Lasso di tempo: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Faecal microflora
Lasso di tempo: Weeks -4 and 0 with respect to vaccination
Weeks -4 and 0 with respect to vaccination
Salivary IgA concentration
Lasso di tempo: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Philip C Calder, PhD, University of Southampton

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2009

Completamento primario (Effettivo)

1 ottobre 2009

Completamento dello studio (Effettivo)

1 luglio 2010

Date di iscrizione allo studio

Primo inviato

20 aprile 2009

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2009

Primo Inserito (Stima)

12 maggio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 dicembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 novembre 2014

Ultimo verificato

1 luglio 2010

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • RHMNUT0055

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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