Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
NCT ID: NCT01677702
Last Updated: 2012-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2011-03-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
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.
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.
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
Total 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.
Recombined low protein milk
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
Interventions
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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.
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
Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
75 Years
ALL
Yes
Sponsors
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Inner Mongolia Yili Industrial Group Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ying An, Ph.D
Role: STUDY_DIRECTOR
Inner Mongolia Hilo Industrial Group Co., Ltd
Donglian Cai
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital of Shanghai, Nutriology Dept.
Yeqing Shi
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital of Shanghai, Rheumatology Dept.
Locations
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NanMoFang Community Health Service Center
Chao Yang District, Beijing Municipality, China
JuQuan Community Health Service Center
GuCun, Baoshan District,, Shanghai Municipality, China
Countries
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Other Identifiers
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YL/CL-002
Identifier Type: -
Identifier Source: org_study_id