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
Conditions
Interventions
Group 1: Run 1: Two capsules of the test preparation BS-85 (Biotikon, Weinheim, Germany
one capsule contains 400 mg dry extract from the resin of Boswellia serrata) once orally with food.
Group 2: Run 2: Eight capsules of the reference preparation Boswellia-Loges (Dr. Loges + Co. GmbH, W
one capsule contains 100 mg dry extract from the resin of Boswellia serrata) once orally with the meal.
Sponsors
University Hospital Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: - Age: =18 to =50 years - Gender: male and female - Ability to give consent
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of boswellic acids after taking the respective test preparation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactTatiana Syrovets
Institut für Naturheilkunde & Klinische Pharmakologie Universität Ulm
Outcome results
None listed