Immune Benefits of Consumption of Dairy Yogurt in Elderly

Study Overview
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Brief Summary
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To investigate the impact of consuming dairy yogurt on immun function including natural killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in elderly.

Detailed Description
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A randomized, open-labelled, placebo-controlled study was conducted on 200 nondiabetic, nonobese and elderly (≥60 years) subjects. Over a twelve-week period, the test group consumed one bottle (120 mL) of dairy yogurt each day, whereas the placebo group consumed same volume of low fat milk daily. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, 1.25:1 or 0.625:1. In addition, cytokines and immunoglobulin levels measured using commercial kits as manufacturer's instruction.

Official Title
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Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old

Conditions
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Immune Deficiency

Intervention / Treatment
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* Dietary Supplement: Probiotic yogurt
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent Over 60 years old without any health problems The levels of white blood cells within range 4x10^3/μL 10x10^3/μL Exclusion Criteria: Individuals who get a cold Diabetes Hypersensitivity or disease history for milk protein Epilepsy, neurological, or psychological disease Alcoholism or drug addiction Liver disease or severe kidney failure disease Inflammation-related disease Consumption of other test products or drugs within 1 month prior to screening Regular consumption of immune-related functional foods including yogurt or milk within 1 month prior to screening History of inflammation-related disease or taking medication to treat inflammation-related disease within 1 month prior to screening History of cancer within 5 years Any inappropriate condition

Ages Eligible for Study
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Minimum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Probiotic yogurt supplementation | Dietary Supplement: Probiotic yogurt<br>* 120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum<br>|
| Placebo Comparator: Placebo group<br>Placebo supplementation | Dietary Supplement: Placebo<br>* 120 mL of low-fat milk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural killer cell activity |  | At baseline | 
| Natural killer cell activity |  | At 12-week follow-up | 
| Change from baseline natural killer cell activity at 12-week |  | At baseline and 12-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White blood cell |  | At baseline | 
| White blood cell |  | At 12-week follow-up | 
| Change from baseline white blood cell at 12-week |  | At baseline and 12-week follow-up | 
| Interleukin-12 |  | At baseline | 
| Interleukin-12 |  | At 12-week follow-up | 
| Change from baseline Interleukin-12 at 12-week |  | At baseline and 12-week follow-up | 
| Interferon-gamma |  | At baseline | 
| Interferon-gamma |  | At 12-week follow-up | 
| Change from baseline Interferon-gamma at 12-week |  | At baseline and 12-week follow-up | 
| Immunoglobulin |  | At baseline | 
| Immunoglobulin |  | At 12-week follow-up | 
| Change from baseline immunoglobulin at 12-week |  | At baseline and 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Immune function, Natural killer cell activity, Interleukin-12, Interferon-gamma, Immunoglobulin