Immune Benefits of Consumption of Dairy Yogurt in Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Immune Deficiency
• Intervention / Treatment: Dietary supplement: Probiotic yogurt; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jong Ho Lee, Yonsei University

Publications and helpful links

General Publications

• Lee A, Lee YJ, Yoo HJ, Kim M, Chang Y, Lee DS, Lee JH. Consumption of Dairy Yogurt Containing Lactobacillus paracasei ssp. paracasei, Bifidobacterium animalis ssp. lactis and Heat-Treated Lactobacillus plantarum Improves Immune Function Including Natural Killer Cell Activity. Nutrients. 2017 May 31;9(6):558. doi: 10.3390/nu9060558.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2016
• Primary Completion (Actual): January 10, 2017
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Probiotics; Immunoglobulin; Interleukin-12; Immune function; Interferon-gamma; Natural killer cell activity
• Additional Relevant MeSH Terms: Immune System Diseases; Immunologic Deficiency Syndromes
• Other Study ID Numbers: CI_immune

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No