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

NCT01677702 — Not applicable, Completed, 240 participants, Inner Mongolia Yili Industrial Group Co., Ltd

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

RegistryNCT01677702
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment240 (Actual)
SponsorInner Mongolia Yili Industrial Group Co., Ltd (Industry)
ConditionsImmunization, Human Influenza, Common Cold
InterventionsYili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml), Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml), Recombined low protein milk (Dietary supplement)
Datesstart 2011-03-01, primary completion 2011-07-01, completion 2011-10-01, first posted 2012-09-03, last updated 2012-10-25
Locations2 sites in China

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Yili Lactoferrin ShuHua Milk (lactoferrin 5mg/100ml)Active comparatorDietary Supplement: 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)Active comparatorDietary Supplement: 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 milkPlacebo comparatorDietary Supplement: Recombined low protein milkTotal 250mL placebo milk will be taken once per day at 10am daily during the 84 days intervention.
  • Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml) (Dietary supplement): 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) (Dietary supplement): 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 (Dietary supplement): Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.

+Outcome measures

Primary outcomes

  • Assess occurrence of flu symptoms during intervention [3 months]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 6 Years to 75 Years, 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

+Locations (2)

FacilityCityCountryStatus
NanMoFang Community Health Service CenterChao Yang District, Beijing MunicipalityChina
JuQuan Community Health Service CenterGuCun, Baoshan District,, Shanghai MunicipalityChina

+Investigators

  • Ying An, Ph.D, Study director, Inner Mongolia Hilo Industrial Group Co., Ltd
  • Donglian Cai, Principal investigator, Changhai Hospital of Shanghai, Nutriology Dept.
  • Yeqing Shi, Principal investigator, Changhai Hospital of Shanghai, Rheumatology Dept.

My Notes