Study to compare the bioavailability of two Boswellia-extract- containing food supplements in healthy volunteers
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
Administration of the micellar extract significantly increased Cmax, AUC0–48, and shortened Tmax for all boswellic and lupeolic acids compared to native extract. Accordingly, their relative bioavailability increased to 1,720-4,291 % with the highest difference for acetyl-11-keto-ß-boswellic acid (AKBA). Both preparations reduced the release of TNF-a and the native formulation diminished also IL-1ß and IL-6. However, no significant differences were observed between the preparations, except for a higher decrease in IL-1ß by the native formulation Biotikon® BS-85. In a lymphocytic gene reporter cell line, both nutraceuticals similarly inhibited the NF-?B transcription factor activity as well as the TNF-a release, yet the native formulation Biotikon®BS-85 was more efficient in inhibiting TNF-a
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Age: =18 to =50 years
- •- Gender: male and female
- •- Ability to give consent
排除标准
- •- Acute or chronic illness, especially infectious diseases or diseases of the immune system.
- •- Taking medication, especially anti-inflammatory drugs, including OTC drugs.
- •- Taking Boswellia supplements.
- •- For women: pregnancy / breastfeeding and women of childbearing age for whom adequate contraception is not guaranteed).
- •- Simultaneous participation in other clinical studies or participation in other clinical studies in the last 30 days.