Immune Function
Conditions
Brief summary
This study was conducted to evaluate the efficacy and safety of heat-treated Lactiplantibacillus plantarum LM1004 in improving immune function in adults. This was a randomized, double-blind, placebo-controlled, single-center clinical trial. Healthy adults aged 19 to 75 years who met the eligibility criteria were enrolled and randomly assigned to receive either the study product or a placebo. Participants in the study group received heat-treated Lactiplantibacillus plantarum LM1004, while participants in the control group received a placebo. The study product or placebo was taken once daily for 8 weeks. The primary outcome of the study was the change in natural killer (NK) cell activity from baseline. Secondary outcomes included changes in immune-related biomarkers, such as cytokines, white blood cell counts, total IgE levels, and fatigue-related questionnaire scores. Safety was evaluated by monitoring adverse events, vital signs, and laboratory test results throughout the study period. The results of this study were intended to determine whether daily intake of heat-treated Lactiplantibacillus plantarum LM1004 is safe and may help improve immune function in adults.
Interventions
DIETARY_SUPPLEMENTHeat-treated Lactiplantibacillus plantarum LM1004
Heat-treated Lactiplantibacillus plantarum LM1004 was administered orally as a capsule at a dose of 500 mg once daily for 8 weeks.
DIETARY_SUPPLEMENTDietary Supplement
The placebo was administered orally as a capsule identical in appearance to the study product, once daily for 8 weeks.
Sponsors
Soon Chun Hyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female adults aged 19 to 75 years * Able to understand the study procedures and provide written informed consent * Willing to comply with the study protocol
Exclusion criteria
* History of chronic or serious medical conditions that could interfere with study participation * Use of medications or supplements that may affect immune function within the screening period * Pregnant or breastfeeding women * Participation in another clinical study within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Natural Killer (NK) Cell Activity | Baseline to Week 8 | The primary outcome was the change in natural killer (NK) cell activity from baseline to the end of the intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Immune-related Biomarkers | Baseline to Week 8 | Changes in immune-related biomarkers, including cytokines and white blood cell counts, from baseline to the end of the intervention period. |
| Change in Fatigue-related Questionnaire Scores | Baseline to Week 8 | Changes in fatigue-related questionnaire scores from baseline to the end of the intervention period. |
Countries
South Korea
Outcome results
None listed