Upper respiratory tract infections Respiratory Upper respiratory tract infections
Conditions
Interventions
Randomised dose allocation of trial or placebo tablets of same size and shape with their identities concealed from supervisors, investigators and participants until outcome data collected and entered
Sponsors
University of Wolverhampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18-30 years 2. Male or female 3. Occupation: student 4. Health status: healthy
Exclusion criteria
Exclusion criteria: 1. Gastro-intestinal (i.e., gut) ailments at the time of the study 2. Previous anaphylactic shock 3. Proneness to food allergies (specifically including sunflower seeds) 4. Severe eczema 5. Autoimmune disorders such as lupus or rheumatoid arthritis 6. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of illness and number of days of illness in each week - frequency of symptoms of infectious illness related to immunity (e.g., flu, cold, mouth ulcers) measured using appropriate scoring methods, and investigators monitor subjects' compliance and collect information regarding incidence/symptoms of infection weekly by pre-arranged telephone contact | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Personal information of volunteer trial subjects (home living arrangements, sleeping habits, medications, supplement usage [including antioxidants], number of URTIs in preceding 12 months, stress, smoking, alcohol intake, exercise frequency), assessed using form completed by volunteer trial subject prior to start of dose-period (trial intervention) 2. Feelings of illness defined from list of URTI symptoms, recorded using weekly diary forms completed by SI for each of their 12 volunteer trial subjects by recording in daily tick-boxes (i.e., record of URTI incidence and days ill) weekly throughout the trial intervention 3. Missed doses, recorded using weekly diary forms completed by SI for each of their 12 volunteer trial subjects by recording in daily tick-boxes weekly throughout the trial intervention 4. Ill effects of the dose and where applicable symptoms, recorded using weekly diary forms completed by SI for each of their 12 volunteer trial subjects weekly throughout the trial intervention 5. Exercise frequency (minimum time-period per iteration 20 mins), recorded using weekly diary forms completed by SI for each of their 12 volunteer trial subjects by recording in daily tick-boxes weekly throughout the trial intervention 6. Doses taken, recorded using form with tick-boxes for each (dated) day of the trial completed by each of the 12 volunteer trial subjects daily throughout the trial intervention 7. Dietary intakes, recorded using diet diary of all the food and drink consumed completed by volunteer trial subjects over two 4-day periods in the 2nd and 7th weeks during the trial intervention 8. Subjective perceptions of subjects, recorded using follow-up questionnaire completed by each of the 12 volunteer trial subjects (including dose identity, benefit, side-effects) following the trial intervention | — |
Countries
United Kingdom
Outcome results
None listed