Healthy Volunteer, URTI
Conditions
Keywords
LC-Plasma, URTI, Healthy volunteer
Brief summary
The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks.
Interventions
DIETARY_SUPPLEMENTLC-Plasma
1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks
OTHERPlacebo
1 tablet containing 50mg MCC is taken daily for 24 weeks
Sponsors
RDC Clinical Pty Ltd
Kirin Holdings Company, Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18-60 years living in Australia * Individuals with a history of recurrent upper respiratory tract infections * Able to provide informed consent * Generally healthy * Agree to not participate in another clinical trial while enrolled in this trial * Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period * Agree not to travel internationally for over 1 month in a single trip during the intervention period (baseline to study completion). * Females of childbearing potential must a prescribed form of birth control
Exclusion criteria
* Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis. * Unstable illness e.g., changing medication/treatment. * BMI \<18.5, \>30 * Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years. * Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease). * Has current symptoms of an acute sickness. * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients in the active or placebo formula * Pregnant or lactating woman * People medically prescribed medications within the last month that would affect the immune and/or the inflammatory response excluding topical steroid use. * Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month * Participants with cognitive damage * Participants with seasonal allergic rhinitis * Regular use of antihistamines * Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence number of URTIs | Day 1 to 24 weeks | Cumulative incidence number of Upper Respiratory Tract Infections (URTIs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative number of infected participants | Day 1 to week 24 | Cumulative number of infected participants |
| Cumulative number of days that participant recorded symptom positive to WURSS-24 system | Day 1 to week 24 | Cumulative number of days that participant recorded symptom positive to WURSS-24 (Wisconsin Upper Respiratory Symptom Survey) scoring system during intervention period. |
| Cumulative scores of each parameter in WURSS-24 scoring system, as well as the total sum of all parameters for each participant. | Day 1 to week 24 | Cumulative scores of each parameter in WURSS-24 scoring system during the intervention period, as well as the total sum of all parameters for each participant. |
| Length of URTI symptomatic days per one URTI episode. | Day 1 to week 24 | Length of Upper Respiratory Tract Infection (URTI) symptomatic days per one URTI episode. |
Countries
Australia
Contacts
STUDY_DIRECTORYusuke Ushida
Kirin Holdings Company, Limited
STUDY_DIRECTOROsamu Kanauchi
Kirin Holdings Company, Limited
Outcome results
None listed