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| ID | Type | Description | Link |
|---|---|---|---|
| DAUH-IRB-2023-08-24 | Other Identifier | Dong-A University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in this arm received heat-treated Lactiplantibacillus plantarum LM1004 once daily for 8 weeks. |
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| Placebo Group | Placebo Comparator | Participants in this arm received a placebo once daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat-treated Lactiplantibacillus plantarum LM1004 | Dietary Supplement | Heat-treated Lactiplantibacillus plantarum LM1004 was administered orally as a capsule at a dose of 500 mg once daily for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Natural Killer (NK) Cell Activity | The primary outcome was the change in natural killer (NK) cell activity from baseline to the end of the intervention period. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Immune-related Biomarkers | Changes in immune-related biomarkers, including cytokines and white blood cell counts, from baseline to the end of the intervention period. | Baseline to Week 8 |
| Change in Fatigue-related Questionnaire Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement | Dietary Supplement | The placebo was administered orally as a capsule identical in appearance to the study product, once daily for 8 weeks. |
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Changes in fatigue-related questionnaire scores from baseline to the end of the intervention period.
| Baseline to Week 8 |