Immune DeficiencyNCT03051425
Immune Benefits of Consumption of Dairy Yogurt in Elderly
A study testing Probiotic yogurt in people with Immune Deficiency, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency
- What is being tested?
- Probiotic yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2016to 8 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Immune Deficiency
- Being tested
- Probiotic yogurt, Placebo
- Keywords
- Probiotics, Immune function, Natural killer cell activity, Interleukin-12, Interferon-gamma, Immunoglobulin
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic yogurtDietary supplement
120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum
PlaceboDietary supplement
120 mL of low-fat milk
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Probiotic yogurt supplementation Receives: Dietary Supplement: Probiotic yogurt |
| Placebo group | Placebo comparator | Placebo supplementation Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural killer cell activity
Measured: At baseline
Natural killer cell activity
Measured: At 12-week follow-up
Change from baseline natural killer cell activity at 12-week
Measured: At baseline and 12-week follow-up
Secondary outcomes (12)
White blood cell
Measured: At baseline
White blood cell
Measured: At 12-week follow-up
Change from baseline white blood cell at 12-week
Measured: At baseline and 12-week follow-up
Interleukin-12
Measured: At baseline
Interleukin-12
Measured: At 12-week follow-up
Change from baseline Interleukin-12 at 12-week
Measured: At baseline and 12-week follow-up
Interferon-gamma
Measured: At baseline
Interferon-gamma
Measured: At 12-week follow-up
Change from baseline Interferon-gamma at 12-week
Measured: At baseline and 12-week follow-up
Immunoglobulin
Measured: At baseline
Immunoglobulin
Measured: At 12-week follow-up
Change from baseline immunoglobulin at 12-week
Measured: At baseline and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start28 Mar 2016
- Primary completion10 Jan 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Ho Lee, Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051425
- Sponsor's protocol ID
- CI_immune
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 13 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28561762
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Benefits of Consumption of Dairy Yogurt Containing Functional Probiotics Among Individuals Over 60 Years Old
- ClinicalTrials.gov ID
- NCT03051425
- Acronym / sponsor ID
- CI_immune
- Conditions
- Immune Deficiency
- Keywords
- Probiotics, Immune function, Natural killer cell activity, Interleukin-12, Interferon-gamma, Immunoglobulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Dietary Supplement: Probiotic yogurtProbiotic yogurt supplementation |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplementation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Individuals who get a cold
- Diabetes
- Hypersensitivity or disease history for milk protein
- Epilepsy, neurological, or psychological disease
- Alcoholism or drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic yogurt120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum | Dietary supplement | Test group |
| Placebo120 mL of low-fat milk | Dietary supplement | Placebo group |
Primary outcome
Natural killer cell activity
Time frame: At baseline
Natural killer cell activity
Time frame: At 12-week follow-up
Change from baseline natural killer cell activity at 12-week
Time frame: At baseline and 12-week follow-up
12 secondary outcomes
White blood cell
Time frame: At baseline
White blood cell
Time frame: At 12-week follow-up
Change from baseline white blood cell at 12-week
Time frame: At baseline and 12-week follow-up
Interleukin-12
Time frame: At baseline
Interleukin-12
Time frame: At 12-week follow-up
Change from baseline Interleukin-12 at 12-week
Time frame: At baseline and 12-week follow-up
Interferon-gamma
Time frame: At baseline
Interferon-gamma
Time frame: At 12-week follow-up
Change from baseline Interferon-gamma at 12-week
Time frame: At baseline and 12-week follow-up
Immunoglobulin
Time frame: At baseline
Immunoglobulin
Time frame: At 12-week follow-up
Change from baseline immunoglobulin at 12-week
Time frame: At baseline and 12-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Derived from this study: PubMed 28561762Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Ho Lee principal investigator
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic yogurt in people with Immune Deficiency, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural killer cell activity (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03051425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.