Immune Benefits of Consumption of Dairy Yogurt in Elderly

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03051425

Collaborator

(none)

200

Enrollment

Location

Arms

10.4

Actual Duration (Months)

19.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Deficiency	Dietary Supplement: Probiotic yogurt Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

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 :

Mar 28, 2016

Actual Primary Completion Date :

Jan 10, 2017

Actual Study Completion Date :

Feb 8, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]
Change from baseline Interleukin-12 at 12-week [At baseline and 12-week follow-up]
Interferon-gamma [At baseline]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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~10x103/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