MedTrace Logo

Relative Bioavailability of Two Different Milk Thistle Formulations

NCT02529605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-06-19

No results posted yet for this study

Summary

This is a single dose, randomized, cross-over pharmacokinetic study in healthy volunteers (n=12) of two dietary supplement formulations. The Product B® IsaGenesis® formulation represents a newer reformulation of an existing product known simply as IsaGenesis®. Beyond some changes in the relative abundance of some of the constituents of the earlier IsaGenesis® formulation, the Product B® IsaGenesis® product has been formulated as a liquid-gel formulation (rather than a dried powder extract) which is theorized to enhance the absorption and bioavailability of the contained botanical constituents. The purpose of this study is to compare the two dietary supplement formulations relative to the absorption of two compounds contained within the supplement known as the flavonolignans silybin A and silybin B into the bloodstream after oral administration of capsules.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Product B® IsaGenesis®

This will be a crossover comparison of a one time dose of the liquid-gel formulation contained in 2 capsules; 1280 mg/capsule.

DIETARY_SUPPLEMENT

IsaGenesis®

This will be a crossover comparison of a one time dose of the dried powder extract contained in 2 capsules; 1070 mg /capsule.

Sponsors & Collaborators

  • Isagenix International LLC

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • John S Markowitz, Pharm.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02529605 on ClinicalTrials.gov