Prebiotics and Immune Function in Middle Aged Humans

NCT ID: NCT00898599

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-07-31

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.

Detailed Description

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).

Conditions

Immune Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin as placebo

Prebiotic

Inulin type fructooligosaccharides

Group Type: EXPERIMENTAL

Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

Inulin type fructooligosaccharides

Interventions

Prebiotic

Inulin type fructooligosaccharides

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin as placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Synergy1; Maltodextrin

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southampton

OTHER

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip C Calder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

University of Southampton

Southampton, , United Kingdom

Countries

United Kingdom

Other Identifiers

RHMNUT0055

Identifier Type: -

Identifier Source: org_study_id