Immune Benefits of Consumption of Dairy Yogurt in Elderly
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2017
CompletedFirst Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedFebruary 13, 2017
February 1, 2017
10 months
February 9, 2017
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Test group
EXPERIMENTALProbiotic yogurt supplementation
Placebo group
PLACEBO COMPARATORPlacebo supplementation
Interventions
120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University
Seoul, 03722, South Korea
Related Publications (1)
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.
PMID: 28561762DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Ho Lee
Yonsei University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 13, 2017
Study Start
March 28, 2016
Primary Completion
January 10, 2017
Study Completion
February 8, 2017
Last Updated
February 13, 2017
Record last verified: 2017-02