NCT02529605

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

August 17, 2015

Last Update Submit

June 15, 2018

Conditions

Healthy

Keywords

dietary supplementpharmacokineticsHealthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC) of Product B® IsaGenesis® versus IsaGenesis®

    0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose

  • Peak Plasma Concentration (Cmax) of Product B® Isagenesis® versus IsaGenesis®

    0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose

Secondary Outcomes (1)

  • Number of Participants With Response to Product B® Isagenesis® versus IsaGenesis®

    6 weeks

Study Arms (2)

Product B® IsaGenesis®, Then IsaGenesis®

ACTIVE COMPARATOR

Participants will come into the clinic in a fasting state to receive the Product B® IsaGenesis®, which will be a one time dose of the liquid-gel formulation contained in 2 capsules, 1280 mg per capsule. After a washout period of 7 days, they will then come back to the clinic in a fasting state to receive the IsaGenesis®. This will be given for a comparison in a one time dose of the dried powder extract contained in 2 capsules; 1070 mg per capsule.

Dietary Supplement: Product B® IsaGenesis®Dietary Supplement: IsaGenesis®

IsaGenesis®, Then Product B® IsaGenesis®

ACTIVE COMPARATOR

Participants will come into the clinic in a fasting state to receive the IsaGenesis®, which will be a one time dose of the dried powder extract contained in 2 capsules; 1070 mg per capsule. After a washout period of 7 days, they will then come back to the clinic in a fasting state to receive the Product B® IsaGenesis®. This will be given for a comparison in a one time dose of the liquid-gel formulation contained in 2 capsules; 1280 mg/capsule.

Dietary Supplement: Product B® IsaGenesis®Dietary Supplement: IsaGenesis®

Interventions

Product B® IsaGenesis®DIETARY_SUPPLEMENT

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

Also known as: milk thistle extract
IsaGenesis®, Then Product B® IsaGenesis®Product B® IsaGenesis®, Then IsaGenesis®
IsaGenesis®DIETARY_SUPPLEMENT

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

Also known as: milk thistle extract
IsaGenesis®, Then Product B® IsaGenesis®Product B® IsaGenesis®, Then IsaGenesis®

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed Informed Consent
  • Race or ethnicity: no restrictions
  • Body Mass Index (BMI) between 18.5 to 28 kg/m2 (inclusive)
  • Satisfactory completion of the screening medical history, physical exam, and laboratory evaluations.
  • Females of child-bearing potential must have a negative urine pregnancy test prior to enrollment and avoid pregnancy during study participation.
  • With the exception of oral contraceptives, subjects must not be taking prescription or over the counter medication for the duration of study participation
  • Subjects must have no ongoing use of any botanical/nutritional supplement, vitamin, or energy drink for the duration of study participation

You may not qualify if:

  • The presence of a known allergy to ragweed and related plants from the Asteraceae/Compositae plant family. Members of this family include ragweed, chrysanthemums, marigolds, daisies, and some others. Milk thistle may cause an allergic reaction in people who are sensitive to these plants.
  • A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease will render subjects ineligible for the study.
  • The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion including;
  • Gastric bezoar
  • Swallowing disorders
  • Strictures
  • Fistulas
  • GI obstruction
  • Severe dysphagia
  • Crohn's disease
  • Diverticulitis
  • A positive urine pregnancy test.
  • Any concomitant prescription medication, over-the-counter medication, herbal or other supplements, and vitamins during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uf Ctsi Crc

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Li WY, Yu G, Hogan RM, Mohandas R, Frye RF, Gumpricht E, Markowitz JS. Relative Bioavailability of Silybin A and Silybin B From 2 Multiconstituent Dietary Supplement Formulations Containing Milk Thistle Extract: A Single-dose Study. Clin Ther. 2018 Jan;40(1):103-113.e1. doi: 10.1016/j.clinthera.2017.11.013. Epub 2017 Dec 19.

    PMID: 29273470DERIVED

MeSH Terms

Interventions

milk-thistle extract

Study Officials

  • John S Markowitz, Pharm.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 20, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

US(1)