We aim to assess the number and severity of Upper Respiratory Tract Infection(URTI)Symptoms reported by participants over a 90 day period commencing in January 2012 in 100 healthy 50-70 year olds pre-screened to exclude symptomatic chronic respiratory or cardiac disease. We will also assess between group difference in immune function measuring LPS-stimulated cytokine and chemokine data and salivary immunoglobulins.
Conditions
Interventions
Product Name: Wellmune WGP (1/3 1/6 glucopolysaccharide)
Pharmaceutical Form: Capsule
INN or Proposed INN: 1,3/1,6 glucopolysaccharide
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age 50-70 years •general good health •BMI 18-40 •consent to all study visits and procedures •community-dwelling •at least 1 self-reported cold in the last 12 months Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • current symptomatic respiratory illness • current oral steroids use • current antibiotic or immunosuppressant medication • known immune or auto-immune disorders (including HIV, ankylosing spondylitis, Crohn’s Disease, Ulcerative Colitis) • low BMI/ eating disorders • severe renal or liver disease • symptomatic heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research objective is to assess the ability of a daily 1-3 1-6 glucopolysaccharide food supplement to prevent or reduce the number of cold and flu symptoms compared to a placebo capsule in a group of 50-70 year olds over a 90 day period. It also aims to assess the severity of any reported symptoms in those taking the supplement compared to placebo. We aim to measure this via daily completion by the participants of a brief health diary stating 1 (=no cold/flu symptoms), 2 (= cold symptoms - from a defined list) or 3 (=flu symptoms - from a defined list). If a participant reports two or more symptoms for two consecutive days then they contact the study team and start to complete a Wisconsin Score (WURSS-21) form which measures the total number and severity of all cold or flu symptoms and the impact this is having on ability to perform everyday tasks.;Secondary Objective: The secondary objective is to assess the effect of the supplement on immune function compared to the placebo treatment. It is proposed this is measured by comparing a blood and saliva sample at the start (Day 0), mid-point (Day 45) and end of the study period (Day 90). This will measure blood markers of immune function (cytokines and chemokines) at resting baseline and again after the blood sample has been tested with a substance mimicking an immune challenge (called LPS). This objective therefore aims to provide information to better understand the supplement's potential for improving immune function and increasing resistance to infection. A further secondary objective is to assess for any difference in the perception of general health and quality of life between those taking the active supplement and placebo treatment. This will be measured using a validated questionnaire called SF-8.;Primary end point(s): The total number of days with URTI symptoms measured using a daily health log. A co-primary outcome is the severity of URTI symptoms as measured by daily WURSS-21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Analysis of bio-markers of immune function. Blood samples - will be analysed by Professor Calder's team for a range of plasma cytokines and chemokines (measured by flow cytometry based upon eBiosciences kits) and culture supernatant chemokines and cytokines (flow cytometry based upon eBiosciences kits), measured pre and post addition of LPS. Chemokines to be measured will be IL-8, MIP-1a, MIP-1b, MCP-1, MIG, G-CSF. Cytokines to be measured will be IL-1b, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-17A, IL-22, TNF-a, IFN-g. Saliva samples - will be analysed for immunoglobulins using immunoassay. It is intended that these tests will provide information on the baseline effects of the supplement on immuen function - both at rest, and after potential immune challenge as stimulated by LPS. This therefore provides new data on the mechanism of the supplement in the study population of 50-70 year olds. this will help to prpovide information on whether immune function may be modified in its resting state using the supplement or only when the body's immune system faces an infectious challenge as modelled by adding LPS to the samples. This could allow a much broader understanding of the potential role of the supplement in infection control. Comparison of response to placebo would also highlight if there is potential to improve the usual pattern of immunosenescence (age-related immune decline) which occurs over the age of 50 years approximately. It is not felt that this data risks causing any harm to the participant. On an individual level these biomarkers are not predictive of specific disease risks and would not affect insurance or medical status. A further secondary outcome relates to genberal health perception as measured by a validated questionnaire - SF-8.;Timepoint(s) of evaluation of this end point: A blood and saliva test will be taken to monitor immune function at the start of the study (pre-treatment), again at Day 45 (mid-point) | — |
Countries
United Kingdom
Outcome results
None listed