Evidence map›Paper›PMID 29273470›Full record

Trial reportClinical therapeutics2018

Relative Bioavailability of Silybin A and Silybin B From 2 Multiconstituent Dietary Supplement Formulations Containing Milk Thistle Extract: A Single-dose Study.

Wen-Yi Li, Guo Yu, Renee M Hogan, Rajesh Mohandas, Reginald F Frye, Eric Gumpricht, John S Markowitz

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02529605 (Relative Bioavailability of Two Different Milk Thistle Formulations), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT02529605 nacompletednot on this map

Relative Bioavailability of Two Different Milk Thistle Formulations: A Single Dose Randomized Crossover Pharmacokinetic Study

TypeinterventionalSponsorUniversity of FloridaRan2015 to 2017Enrolled12ConditionsHealthyArmsProduct B® IsaGenesis®, IsaGenesis®
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
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

7 authors.

Wen-Yi LiDepartment of Pharmacotherapy and Translational Research, University of Florida, Gainesville, Florida.
Guo YuDepartment of Pharmacotherapy and Translational Research, University of Florida, Gainesville, Florida; Drug Clinical Trial Institution, Subei People's Hospital, Yangzhou, Jiangsu, China.
Renee M HoganDivision of Nephrology, Hypertension, and Renal Transplantation, University of Florida, Gainesville, Florida.
Rajesh MohandasDepartment of Medicine, Nephrology and Hypertension Section, Department of Veterans Affairs Medical Center, North Florida/South Georgia Veterans Health System, Gainesville, Florida; Division of Nephrology, Hypertension, and Renal Transplantation, University of Florida, Gainesville, Florida.
Reginald F FryeDepartment of Pharmacotherapy and Translational Research, University of Florida, Gainesville, Florida.
Eric GumprichtIsagenix International LLC, Gilbert, Arizona.
John S MarkowitzDepartment of Pharmacotherapy and Translational Research, University of Florida, Gainesville, Florida. Electronic address: jmarkowitz@cop.ufl.edu.

Funding

UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Vascular Smooth Muscle Lysyl Oxidase Mediated Increase in Vessel Stiffness and its Effect on Rho-Kinase Mechanosensors: A Novel Mechanism of Atherosclerosis in Chronic Kidney Disease?K08HL130945 · NHLBI · UNIVERSITY OF FLORIDA · PI MOHANDAS, RAJESH · 2016 to 2021
$826k
NCATS NIH HHS UL1 TR000064NHLBI NIH HHS K08 HL130945
6 · The paper itself

Abstract

purposeThe purpose of this study was to compare the bioavailability between 2 milk thistle-containing dietary supplements, Product B and IsaGenesis, in healthy volunteers.

methodsBioavailability between Product B, originally formulated as a powdered capsule, and IsaGenesis, reformulated as a soft gel, were compared by measuring silybin A and silybin B as surrogate pharmacokinetic markers for differences in absorption and bioavailability. For this randomized, open-label, crossover pharmacokinetic study, 12 healthy volunteers consumed a single-dose serving of each supplement separated by at least a 7-day washout period. Serial blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours and analyzed via LC-MS/MS.

findingsRapid absorption and elimination of silybin A and silybin B have been observed after oral administration of both Product B and IsaGenesis. However, the absorption rate and extent, as indicated by mean the C IMPLICATIONS: The IsaGenesis soft gel formulation provided substantially greater absorption and bioavailability of silybin A and silybin B relative to the powdered Product B supplement. ClinicalTrials.gov Identifier: NCT02529605.

Indexed as

Dietary SupplementsSilybum marianumAdministration, OralAdultAntioxidantsArea Under CurveBiological AvailabilityCapsulesChromatography, LiquidCross-Over StudiesDrug CompoundingFemaleGelsHumansMalePlant ExtractsAntioxidantsCapsulesGelsPlant ExtractsPowdersSilybinSilymarinabsorptionformulationmilk thistlepharmacokinetic propertiessilybin

Identifiers

PMID29273470
PMCPMC6037411

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Registered trials

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 OpenQuestion graph.