Prebiotics and Immune Function in Middle Aged Humans

NCT00898599 | Completed Phase 1

• 1 other identifier: RHMNUT0055
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune Function

Outcome Measures

Primary Outcomes (1)

• Serum anti-vaccine antibody concentrations

  Weeks 2 and 4 post-vaccination

Secondary Outcomes (7)

• Serum total antibody (IgG, IgA, IgM) concentrations

  Weeks -4, 0, 2 and 4 with respect to vaccination

• Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst

  Weeks -4, 0, 2 and 4 with respect to vaccination

• Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)

  Weeks -4, 0, 2 and 4 with respect to vaccination

• Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)

  Weeks 0, 2 and 4 with respect to vaccination

• Ex vivo natural killer cell activity

  Weeks -4, 0, 2 and 4 with respect to vaccination

Study Arms (2)

Maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Prebiotic

EXPERIMENTAL

Inulin type fructooligosaccharides

Dietary Supplement: Prebiotic

Interventions

Prebiotic DIETARY_SUPPLEMENT

Inulin type fructooligosaccharides

Also known as: Synergy1

Prebiotic

Placebo DIETARY_SUPPLEMENT

Maltodextrin as placebo

Also known as: Maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 45 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator

Study Sites (1)

University of Southampton

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Interventions

Prebiotics; maltodextrin

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Philip C Calder, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: May 12, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: July 1, 2010
• Last Updated: December 2, 2014

Record last verified: 2010-07

Locations

GB (1)