Effect of Immune X on Common Cold Incidence in Healthy Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGivaudan France Naturals
About this trial
The goal of this clinical trial is to learn if Immune X can help prevent common cold events in healthy adults who have a history of upper respiratory tract infections. The main questions it aims to answer are:
* Does Immune X reduce the proportion of participants who experience at least one clinically confirmed common cold event during the study period? * Does Immune X affect the number, duration, and severity of common cold events?
Researchers will compare Immune X to a placebo (a look-alike capsule containing inactive ingredients) to see if Immune X helps prevent common cold events.
Participants will:
* Take Immune X or placebo daily for 16 weeks during the winter season. * Attend study visits at the beginning and end of the study and complete questionnaires and symptom assessments throughout the study. * Record cold symptoms, medications, and other study information using a smartphone application. * Provide blood and stool samples during the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women aged 18 to 65 years.
History of at least two upper respiratory tract infections during the previous winter season.
Body mass index between 18 and 30 kg/m².
Generally healthy, as determined by the investigator.
Disqualifiers
Current or recent upper respiratory tract infection or COVID-19 infection within 2 weeks before enrollment.
Acute gastrointestinal infection, including gastroenteritis, within 2 weeks before enrollment.
Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before enrollment.
Use of systemic antibiotics within 3 months before enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
Immune X
Dietary supplement500 mg Immune X daily as capsules for 16 weeks.
Placebo
Other interventionMatching placebo capsules daily for 16 weeks.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Immune XExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Participants With at Least One Clinically Confirmed Cold Event
Proportion of participants with at least one clinically confirmed cold event.
Time frame
Week 2 to Week 16Secondary outcomes
1
Number of Clinically Confirmed Cold Events
Mean number of clinically confirmed cold events per participant.
Time frame
Week 2 to Week 162
Duration of Clinically Confirmed Cold Events
Duration of clinically confirmed cold events measured in days.
Time frame
Week 2 to Week 163
Upper Respiratory Symptoms of Clinically Confirmed Cold Events
Wisconsin Upper Respiratory Symptom Survey (WURSS-24): Zero is equivalent to no symptoms and 7 indicates severe.
Time frame
Week 2 to Week 164
Cold Symptoms of Clinically Confirmed Cold Events
Jackson Cold Scale: 0 is equivalent to absent symptoms and 3 indicates severe symptoms
Time frame
Week 2 to Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Givaudan France Naturals
Lead sponsor
CEN Expérimental
Collaborator
Source ClinicalTrials.gov