Immune Benefits of Consumption of Dairy Yogurt in Elderly

Not Applicable

Completed

• Conditions: Immune Deficiency
• Interventions: Dietary Supplement: Probiotic yogurt; Dietary Supplement: Placebo

• Registration Number: NCT03051425
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-28
• Primary Completion: 2017-01-10
• Status Verified: 2017-02
• Study Completion: 2017-02-08
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Study First Posted: 2017-02-13
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Probiotic yogurt	Probiotic yogurt supplementation
Placebo group	Placebo	Placebo supplementation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Interleukin-12	At 12-week follow-up
Change from baseline immunoglobulin at 12-week	At baseline and 12-week follow-up
Interferon-gamma	At 12-week follow-up
White blood cell	At 12-week follow-up
Change from baseline Interferon-gamma at 12-week	At baseline and 12-week follow-up
Change from baseline white blood cell at 12-week	At baseline and 12-week follow-up
Change from baseline Interleukin-12 at 12-week	At baseline and 12-week follow-up
Immunoglobulin	At 12-week follow-up

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of