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

Inner Mongolia Yili Industrial Group

Status: Completed

Conditions: Human Influenza; Immunization; Common Cold

Treatments: Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml); Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml); Dietary Supplement: Recombined low protein milk

Study type: Interventional

Funder types: Industry

Identifiers

NCT01677702

YL/CL-002

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 6 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups, including a placebo group

Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)

Active Comparator group

Description:

Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.

Treatment:

Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)

Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)

Active Comparator group

Description:

Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.

Treatment:

Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)

Recombined low-protein milk

Placebo Comparator group

Description:

Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.

Treatment:

Dietary Supplement: Recombined low protein milk