Study to compare the bioavailability of two Boswellia-extract- containing food supplements in healthy volunteers

Not Applicable

• Conditions: To determine the bioavailability of the bioactive boswellic acid and lupeolic acid species in two Boswellia-extract- containing food supplements. A second secondary endpoint is a comparative study of the cytokine secretion by whole blood after administration of the test preparations

• Registration Number: DRKS00027369
• Lead Sponsor: niversity Hospital Ulm

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-02
• Study Completion: 2022-03-04
• Results First Posted: 2024-07-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age: =18 to =50 years
- Gender: male and female
- Ability to give consent

Exclusion Criteria

- 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of boswellic acids after taking the respective test preparation.

Secondary Outcome Measures

Name	Time	Method
Amount of proinflammatory cytokines such as TNF-a and IL-1ß synthesized ex vivo by peripheral blood mononuclear cells isolated from the whole blood of the test subjects.