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Immune Benefits of Consumption of Dairy Yogurt in Elderly

Primary Purpose

Immune Deficiency

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probiotic yogurt
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Immune Deficiency focused on measuring Probiotics, Immune function, Natural killer cell activity, Interleukin-12, Interferon-gamma, Immunoglobulin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Placebo group

Arm Description

Probiotic yogurt supplementation

Placebo supplementation

Outcomes

Primary Outcome Measures

Natural killer cell activity
Natural killer cell activity
Change from baseline natural killer cell activity at 12-week

Secondary Outcome Measures

White blood cell
White blood cell
Change from baseline white blood cell at 12-week
Interleukin-12
Interleukin-12
Change from baseline Interleukin-12 at 12-week
Interferon-gamma
Interferon-gamma
Change from baseline Interferon-gamma at 12-week
Immunoglobulin
Immunoglobulin
Change from baseline immunoglobulin at 12-week

Full Information

First Posted
February 9, 2017
Last Updated
February 9, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03051425
Brief Title
Immune Benefits of Consumption of Dairy Yogurt in Elderly
Official Title
Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 28, 2016 (Actual)
Primary Completion Date
January 10, 2017 (Actual)
Study Completion Date
February 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Deficiency
Keywords
Probiotics, Immune function, Natural killer cell activity, Interleukin-12, Interferon-gamma, Immunoglobulin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
Probiotic yogurt supplementation
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic yogurt
Intervention Description
120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
120 mL of low-fat milk
Primary Outcome Measure Information:
Title
Natural killer cell activity
Time Frame
At baseline
Title
Natural killer cell activity
Time Frame
At 12-week follow-up
Title
Change from baseline natural killer cell activity at 12-week
Time Frame
At baseline and 12-week follow-up
Secondary Outcome Measure Information:
Title
White blood cell
Time Frame
At baseline
Title
White blood cell
Time Frame
At 12-week follow-up
Title
Change from baseline white blood cell at 12-week
Time Frame
At baseline and 12-week follow-up
Title
Interleukin-12
Time Frame
At baseline
Title
Interleukin-12
Time Frame
At 12-week follow-up
Title
Change from baseline Interleukin-12 at 12-week
Time Frame
At baseline and 12-week follow-up
Title
Interferon-gamma
Time Frame
At baseline
Title
Interferon-gamma
Time Frame
At 12-week follow-up
Title
Change from baseline Interferon-gamma at 12-week
Time Frame
At baseline and 12-week follow-up
Title
Immunoglobulin
Time Frame
At baseline
Title
Immunoglobulin
Time Frame
At 12-week follow-up
Title
Change from baseline immunoglobulin at 12-week
Time Frame
At baseline and 12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28561762
Citation
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.
Results Reference
derived

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Immune Benefits of Consumption of Dairy Yogurt in Elderly

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