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

Not Applicable

Completed

• Conditions: Immunization; Human Influenza; Common Cold
• Interventions: Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml); Dietary Supplement: Recombined low protein milk; Dietary Supplement: Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)

• Registration Number: NCT01677702
• Lead Sponsor: Inner Mongolia Yili Industrial Group Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yili Lactoferrin ShuHua Milk (lactoferrin 10mg/100ml)	Yili 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.
Recombined low-protein milk	Recombined low protein milk	Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.
Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)	Yili 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.

Primary Outcome Measures

Name	Time	Method
Assess occurrence of flu symptoms during intervention	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

NanMoFang Community Health Service Center; 🇨🇳 Chao Yang District, Beijing, China

JuQuan Community Health Service Center; 🇨🇳 GuCun, Baoshan District,, Shanghai, China