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Immune Benefits of Consumption of Dairy Yogurt in Elderly

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ClinicalTrials.gov Identifier: NCT03051425
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Immune Deficiency Dietary Supplement: Probiotic yogurt Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old
Actual Study Start Date : March 28, 2016
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : February 8, 2017

Arm Intervention/treatment
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

Placebo Comparator: Placebo group
Placebo supplementation
Dietary Supplement: Placebo
120 mL of low-fat milk




Primary Outcome Measures :
  1. Natural killer cell activity [ Time Frame: At baseline ]
  2. Natural killer cell activity [ Time Frame: At 12-week follow-up ]
  3. Change from baseline natural killer cell activity at 12-week [ Time Frame: At baseline and 12-week follow-up ]

Secondary Outcome Measures :
  1. White blood cell [ Time Frame: At baseline ]
  2. White blood cell [ Time Frame: At 12-week follow-up ]
  3. Change from baseline white blood cell at 12-week [ Time Frame: At baseline and 12-week follow-up ]
  4. Interleukin-12 [ Time Frame: At baseline ]
  5. Interleukin-12 [ Time Frame: At 12-week follow-up ]
  6. Change from baseline Interleukin-12 at 12-week [ Time Frame: At baseline and 12-week follow-up ]
  7. Interferon-gamma [ Time Frame: At baseline ]
  8. Interferon-gamma [ Time Frame: At 12-week follow-up ]
  9. Change from baseline Interferon-gamma at 12-week [ Time Frame: At baseline and 12-week follow-up ]
  10. Immunoglobulin [ Time Frame: At baseline ]
  11. Immunoglobulin [ Time Frame: At 12-week follow-up ]
  12. Change from baseline immunoglobulin at 12-week [ Time Frame: At baseline and 12-week follow-up ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051425


Locations
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Korea, Republic of
Yonsei University
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jong Ho Lee Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03051425    
Other Study ID Numbers: CI_immune
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Probiotics
Immune function
Natural killer cell activity
Interleukin-12
Interferon-gamma
Immunoglobulin
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases