Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective in reducing the occurrence of flu symptoms.

Official Title
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The Clinical Research on the Efficiency of Yili Lactoferrin Shuhua Milk in the Improvement of Human Immunization

Conditions
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Common Cold, Immunization, Human Influenza

Intervention / Treatment
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* Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)
* Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)
* Dietary Supplement: Recombined low protein milk


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)<br>Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention. | Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)<br>* Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.<br>|
| Active Comparator: Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)<br>Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention. | Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)<br>* Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.<br>|
| Placebo Comparator: Recombined low-protein milk<br>Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention. | Dietary Supplement: Recombined low protein milk<br>* Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess occurrence of flu symptoms during intervention |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |