NCT04029558已完成不适用
Pilot Study of Nutritional Intervention, Randomized, Double Blind and Controlled Parallel Groups to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP024) on the Immune Response in Adults
Biosearch S.A.2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- IgG
研究概览
简要总结
The aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response.
详细描述
More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.
The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL_EP024) on immunological response parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult between 18 and 55 years.
- •Accept freely to participate in the study and sign the informed consent document.
排除标准
- •Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).
- •Have allergy to some plant extracts
- •Suffer from gastric problems or ulcers.
- •Receive treatment with anticoagulant activity.
- •Have a low expectation of adherence to the study protocol.
结局指标
主要结局
IgG
时间窗: 4 weeks
Immunoglobulin G plasma levels
IgM
时间窗: 4 weeks
Immunoglobulin M plasma levels
IgA
时间窗: 4 weeks
Immunoglobulin A plasma levels
次要结局
- TNF-alpha(4 weeks)
- IL-8(4 weeks)
- IL-2(4 weeks)
研究者
研究点 (2)
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