- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00898599
Prebiotics and Immune Function in Middle Aged Humans
Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
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
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
-
Southampton, Regno Unito, SO16 6YD
- University of Southampton
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
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:
|
|
Sperimentale: Prebiotic
Inulin type fructooligosaccharides
|
Inulin type fructooligosaccharides
Altri nomi:
|
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
Collaboratori
Investigatori
- Investigatore principale: Philip C Calder, PhD, University of Southampton
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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 .
Prove cliniche su Funzione immunitaria
-
Paul SzabolcsReclutamentoMalattia granulomatosa cronica | Sindrome di DiGeorge | Disregolazione immunitaria | Immunodeficienza variabile comune (CVID) | Sindrome di Omen | Carenza di ligando CD40 | Suscettibilità mendeliana alla malattia micobatterica | Disturbo primario della regolazione immunitaria | STAT 1 Gain of Function | STAT... e altre condizioniStati Uniti