A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Heat-Treated Lactiplantibacillus Plantarum LM1004 on Immune Function in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Natural Killer (NK) Cell Activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
Participants in this arm received heat-treated Lactiplantibacillus plantarum LM1004 once daily for 8 weeks.
干预措施: Heat-treated Lactiplantibacillus plantarum LM1004 (Dietary Supplement)
Placebo Group
Participants in this arm received a placebo once daily for 8 weeks.
干预措施: Dietary Supplement (Dietary Supplement)
结局指标
主要结局
Change in Natural Killer (NK) Cell Activity
时间窗: 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.
次要结局
- Change in Immune-related Biomarkers(Baseline to Week 8)
- Change in Fatigue-related Questionnaire Scores(Baseline to Week 8)
研究者
Ho-Yeon Song
Professor
Soon Chun Hyang University