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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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

49

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 66 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Maltodextrin
Maltodextrin som placebo
Andre navne:
  • Maltodextrin
Eksperimentel: Prebiotic
Inulin type fructooligosaccharides
Inulin type fructooligosaccharides
Andre navne:
  • Synergi 1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Serum anti-vaccine antibody concentrations
Tidsramme: Weeks 2 and 4 post-vaccination
Weeks 2 and 4 post-vaccination

Sekundære resultatmål

Resultatmål
Tidsramme
Serum total antibody (IgG, IgA, IgM) concentrations
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Weeks 0, 2 and 4 with respect to vaccination
Weeks 0, 2 and 4 with respect to vaccination
Ex vivo natural killer cell activity
Tidsramme: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Faecal microflora
Tidsramme: Weeks -4 and 0 with respect to vaccination
Weeks -4 and 0 with respect to vaccination
Salivary IgA concentration
Tidsramme: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Philip C Calder, PhD, University of Southampton

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. oktober 2009

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

20. april 2009

Først indsendt, der opfyldte QC-kriterier

11. maj 2009

Først opslået (Skøn)

12. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. november 2014

Sidst verificeret

1. juli 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RHMNUT0055

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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