Evidence map›Paper›PMID 39262660›Full record

ArticleJournal of traditional and complementary medicine2024

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

Michael A Liss, Furkan Dursun, G Lavender Hackman, Mohamed I Gadallah, Achinto Saha, Chelsea A Friedman, Atul S Rathore, Preeti Chandra, James R White, Stefano Tiziani and 1 more

Abstract read
In one paragraph

Article in Journal of traditional and complementary medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. The logarithmic phase as a therapeutic direction: evaluating pharmacological strategies against cancer progression.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Michael A LissDepartment of Urology, University of Texas Health San Antonio, San Antonio, TX, USA.
Furkan DursunDepartment of Urology, University of Texas Health San Antonio, San Antonio, TX, USA.
G Lavender HackmanDepartment of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.
Mohamed I GadallahDepartment of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.
Achinto SahaDivision of Pharmacology & Toxicology, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA.
Chelsea A FriedmanDivision of Pharmacology & Toxicology, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA.
Atul S RathoreDepartment of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.
Preeti ChandraDepartment of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.
James R WhiteResphera Biosciences, USA.
Stefano TizianiDepartment of Nutritional Sciences, College of Natural Science, The University of Texas at Austin, USA.
John DiGiovanniDivision of Pharmacology & Toxicology, College of Pharmacy, The University of Texas at Austin, Austin, TX, USA.

Funding

TISSUE CULTURE---COREP30CA054174 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Lei Zheng · 1991 to 2026
$59.1M
Identification of Natural Compound Combinations for Prevention of Prostate CancerR01CA228404 · NCI · UNIVERSITY OF TEXAS AT AUSTIN · PI DIGIOVANNI, JOHN, TIZIANI, STEFANO · 2019 to 2023
$2.5M
NCI NIH HHS P30 CA054174NCI NIH HHS R01 CA228404
6 · The paper itself

Abstract

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.

Indexed as

Cancer preventionCurcuminMicrobiomePhytochemicalsProstateUrsolic acid

Identifiers

PMID39262660
PMCPMC11384084

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.