Influence of Thymoquinone on the Human Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Changes in bacterial taxa in fecal samples
研究概览
简要总结
For many patients, the additive use of dietary supplements without side effects is motivating for therapy and enhances quality of life. The oil of the plant Nigella sativa (NS), a dietary supplement containing Thymoquinone (TQ) as its main active compound, exhibits hepatoprotective effects through antioxidative, antifibrotic, and anti-inflammatory properties, and also demonstrates anticancer and antiapoptotic activities. In vitro and in vivo studies have shown that TQ can also influence the gut microbiome. However, no clinical studies are currently available that describe the specific extent of TQ's influence on the human intestinal microbiome and its potential effects on the outcome after gastrointestinal surgery.
The aim of the project is therefore to investigate changes in the human microbiome following the intake of Nigella sativa seed oil capsules containing TQ as the main active ingredient. The study will test the hypothesis that TQ, through its diverse mechanisms of action, modulates the composition of the microbiome and thereby exerts a positive effect on immune response and intestinal healing processes. In parallel, TQ metabolites in urine will be analyzed using Liquid Chromatography-Mass Spectrometry (LC-MS) to gain insights into the pharmacokinetic profile of the compound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no recent medication use
- •no history of gastrointestinal surgery
- •no pregnancy
- •no allergies to NSSO or its derivatives
- •18 years and above
排除标准
- •regular medication
- •history of gastrointestinal surgery
- •pregnancy
- •allergies to NSSO or its derivates
- •presence of chronic illness
- •below the age of 18 years
研究组 & 干预措施
Treatment group
Intake of two TQ-containing NSSO capsules three times daily for 20 days and fecal sampling at five time points.
干预措施: Intake of Thymoquinone (TQ) containing Nigella Sativa Seed Oil (NSSO) capsules (Dietary Supplement)
Control group
Fecal sampling at five time points without supplementation.
结局指标
主要结局
Changes in bacterial taxa in fecal samples
时间窗: From enrollment to the end of treatment at 20 days.
次要结局
未报告次要终点
研究者
Aysun Tekbaş
Dr. med., MME
Jena University Hospital
