Common Cold, Human Influenza, Immunization
Conditions
Brief summary
The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.
Interventions
DIETARY_SUPPLEMENTYili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)
Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
DIETARY_SUPPLEMENTYili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)
Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
DIETARY_SUPPLEMENTRecombined low protein milk
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
Sponsors
Inner Mongolia Yili Industrial Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 6 to 12 years, catch cold for 4 to 6 times in last year; * Age 35 to 45 years, catch cold for 4 to 6 times in recent 3 month; * Age 60 to 75 years, catch cold for 4 to 6 times in last year; * BMI 18.5to 29.9kg/m2; * Able to understand the nature and purpose of the study including potential risks and side effects
Exclusion criteria
* Recent (within 6 months of screening) been vaccinated influenza vaccine, or recent (within 15 days of screening) been vaccinated ther vaccines; * Suffering from rhinitis chronic, laryngitis, labored breathing that similar to flu symptoms. Such as chronic allergic rhinitis, asthma, COPD; * Long-term use of any prescription or OTC medication that inhibit or prevent flu symptoms, including but not limited to, antihistamine, pectoral, high doses of vitamin C; * Recent use (within 3 months of screening) of any prescription or OTC medication that significantly affects immune response, such as antibiotic; * Known allergies to dairy and any substance in the study product; * History of alcohol, drug, or medication abuse * Pregnant or breastfeeding women * Recent daily use (within 3 months of screening) of any probiotics, clabber or yogurt; * Any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess occurrence of flu symptoms during intervention | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Assess severity of flu symptoms | 3 months |
| Proportion of subjects which require treatment with flu medication | 3 months |
| Change in immune markers such as antibodies and interleukins | Baseline & 3 months |
| Record subject sick leave due to flu | 3 months |
Countries
China
Outcome results
None listed