Phase 1 clinical trial evaluating safety, bioavailability, and gut microbiome with a combination of curcumin and ursolic acid in lipid enhanced capsules.

Autor:	Liss MA; Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA., Dursun F; Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA., Hackman GL; Department of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA., Gadallah MI; Department of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut, 71526, Egypt., Saha A; Division of Pharmacology & Toxicology, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA., Friedman CA; Division of Pharmacology & Toxicology, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA., Rathore AS; Department of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA., Chandra P; Department of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA., White JR; Resphera Biosciences, USA., Tiziani S; Department of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.; Department of Pediatrics, Dell Medical School, The University of Texas at Austin, Austin, TX, 78723, USA.; Department of Oncology, Dell Medical School, Livestrong Cancer Institutes, The University of Texas at Austin, Austin, TX, 78723, USA., DiGiovanni J; Division of Pharmacology & Toxicology, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA.; Department of Pediatrics, Dell Medical School, The University of Texas at Austin, Austin, TX, 78723, USA.; Department of Oncology, Dell Medical School, Livestrong Cancer Institutes, The University of Texas at Austin, Austin, TX, 78723, USA.; Center for Molecular Carcinogenesis and Toxicology, The University of Texas at Austin, Austin, TX, USA.
Jazyk:	angličtina
Zdroj:	Journal of traditional and complementary medicine [J Tradit Complement Med] 2024 Mar 07; Vol. 14 (5), pp. 558-567. Date of Electronic Publication: 2024 Mar 07 (Print Publication: 2024).
DOI:	10.1016/j.jtcme.2024.03.002
Abstrakt:	As screening strategies employ better biomarkers and genetics to identify individuals at an increased risk of prostate cancer, there are currently no chemotherapeutic prevention strategies. With any chemoprevention strategy, the population will be younger and healthier; therefore, they will be less tolerant of side effects. This study translated findings from screening a natural product library and pre-clinical evaluation of curcumin (CURC) in combination with ursolic acid (UA) in prostate cancer models. After manufacturing capsules for each compound, 18 subjects were enrolled. The study used a 3 × 3 phase 1 clinical trial to evaluate CURC (1200 mg/day) and UA (300 mg/day) alone and in combination over a 2-week period with endpoints of safety, bioavailability, and microbiome alterations. After enrolling six subjects in each arm, we found no grade 3 or 4 events and only minor changes in the safety laboratory values. In the pooled analysis of groups, we noted a statistically significant difference between median serum levels of UA when administered alone vs administered in the combination (2.7 ng/mL vs 43.8 ng/mL, p = 0.03). Individuals receiving the combination also had a favorable impact on gut microbiome status and a reduction in "microbiome score" predictive of prostate cancer risk. Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Michael Liss has patent #WO2023091668A1 issued to John DiGiovanni. (© 2024 Center for Food and Biomolecules, National Taiwan University. Production and hosting by Elsevier Taiwan LLC.)
Databáze:	MEDLINE
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