- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898599
Prebiotics and Immune Function in Middle Aged Humans
Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Southampton, United Kingdom, SO16 6YD
- University of Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Maltodextrin
|
Maltodextrin as placebo
Other Names:
|
Experimental: Prebiotic
Inulin type fructooligosaccharides
|
Inulin type fructooligosaccharides
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum anti-vaccine antibody concentrations
Time Frame: Weeks 2 and 4 post-vaccination
|
Weeks 2 and 4 post-vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum total antibody (IgG, IgA, IgM) concentrations
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: Weeks 0, 2 and 4 with respect to vaccination
|
Weeks 0, 2 and 4 with respect to vaccination
|
Ex vivo natural killer cell activity
Time Frame: Weeks -4, 0, 2 and 4 with respect to vaccination
|
Weeks -4, 0, 2 and 4 with respect to vaccination
|
Faecal microflora
Time Frame: Weeks -4 and 0 with respect to vaccination
|
Weeks -4 and 0 with respect to vaccination
|
Salivary IgA concentration
Time Frame: Weeks -4, 0, 2 and 4 with respect to vaccination
|
Weeks -4, 0, 2 and 4 with respect to vaccination
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Philip C Calder, PhD, University of Southampton
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RHMNUT0055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immune Function
-
International Centre for Diarrhoeal Disease Research...University of Chicago; Marquette University; Mailman School of Public HealthRecruitingAir Pollution | Cardiopulmonary Function | Immune Function | mHealth InterventionBangladesh
-
University of ReadingDaniscoCompletedGut Microbiota | Immune Function | Bowel Function | Plasma LipidsUnited Kingdom
-
Green Cross WellbeingNot yet recruitingImmune FunctionKorea, Republic of
-
Chonbuk National University HospitalCompleted
-
Shanghai Cell Therapy Group Co.,LtdShanghai Mengchao Cancer HospitalNot yet recruiting
-
University of MemphisMannatechCompletedMicrobiome | Immune FunctionUnited States
-
Martin AngstCompletedNormal Immune Cell FunctionUnited States
-
University of ReadingDaniscoCompletedGut Microbiota | Immune FunctionUnited Kingdom
-
University of California, DavisCalifornia Walnut CommissionCompletedImmune Function | Cardiovascular HealthUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States