Wellmune for the prevention of URTI in a 50 to 70 year old population

• Research type

  Research Study

• Full title

  A Randomised Controlled Trial to assess a food supplement (baker’s yeast extract) to support immune function and prevent cold and flu symptoms in a 50 to 70 year old population

• IRAS ID

  42102

• Contact name

  Richard Fuller

• Eudract number

  2011-004910-41

• ISRCTN Number

  n/a

• Research summary

  Upper respiratory tract infection (URTI), often termed the "common cold", is the most frequent infectious disease in humans. It is a leading cause of sickness-related absence and a frequent reason for medical review. Strategies to prevent or treat URTI remain limited. New approaches could provide significant health and socioeconomic benefits. This trial aims to assess a food supplement derived from bakeris yeast (called 1/3-1/6 glucopolysaccharide) to support immune function and increase resistance to cold and flu symptoms in community-dwelling people aged 50 to 70 years. It has previously shown ability to improve immune cell function and is available over the counter in UK. This is the first time the supplement would be tested in this population at risk of age-related immune decline and complications from URTI. Invitations will be sent, aiming to recruit 100 Participants from a GP surgery population, where assessments will take place. They will be asked to have a blood and saliva test at the start, mid-point and end of the study, comparing immune function (LPS-stimulated cytokine levels) and salivary defences to infection (immunoglobulin levels). Over 90 days they will take either the supplement or identical rice-flour placebo capsule once daily during peak URTI months. Neither Participants norestudy team will know who is taking which capsule. Participants will complete a daily diary recording prisence or absence of URTI symptoms and if a cold develops will complete a questionnaire (WUris-21) highlighting the duration and severity of symptoms. General health (SF8), missed pills and any side effects will be monitored every 45 days. This trial, funded by the supplement manufacturer, Biothera, aims to further knowledge of 1/3-1/6 gluocpolysaccharide Effectiveness to improve markers of immune function and reduce the burden of URTI. It may lead to larger trials and development of preventative strategies by improving frontline immune response.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  11/SC/0520

• Date of REC Opinion

  30 Dec 2011

• REC opinion

  Further Information Favourable Opinion