HealthyNCT02529605
Relative Bioavailability of Two Different Milk Thistle Formulations
A study testing Product B® IsaGenesis® and IsaGenesis® in people with Healthy, run by University of Florida at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Product B® IsaGenesis® and IsaGenesis®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Bioavailability of Two Different Milk Thistle Formulations: A Single Dose Randomized Crossover Pharmacokinetic Study
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.
Read the detailed description
The study involves a total of five (5) visits to the University of Florida Shands CRC located in the Clinical Translational Research Building in Gainesville, and is expected to last approximately 6 weeks.
Screening / Informed Consent:
The Screening Visit will be conducted in the CRC and is expected to last approximately 1 hour.
After obtaining written Informed Consent, study subjects will be interviewed about their medical history and the protocol's Inclusion/Exclusion criteria will be discussed. All potential participants must be nonsmokers, not taking prescription or over-the-counter medications or botanical/nutritional supplements (inclusive of vitamins). Additionally, participants are requested to abstain from alcohol use 24 hours prior to the study health screen lab work or any scheduled study visit should they participate fully in the study.
During this initial visit, interested subjects will have blood samples drawn for health screening purposes including baseline serum chemistries, complete blood count, urinalysis, and a urine pregnancy test (women) which will precede a subsequently scheduled physical exam and possible study participation. Copies of the laboratory results will be made available to study subjects at their request. Lastly, a 12-lead electrocardiogram will be obtained.
Study Visits The following section describes the study procedures for the two major study visits at the CRC following Informed Consent and a satisfactory medical screening.
Following an overnight fast (abstention from eating any food items after 9 pm in the evening prior to the scheduled visit), subjects will arrive at the CRC the morning of the active Study Days where they will remain for approximately 8 hours on each day. After checking in, and under medical supervision, skilled CRC staff will place an indwelling venous catheter in each subject's arm to facilitate serial blood sampling. Female subjects will provide a urine sample for a pregnancy test. At approximately 8:00 AM subjects will be administered 2 capsules of either Product B® IsaGenesis® (2 capsules; 1280 mg per capsule) or IsaGenesis® (2 capsules; 1070 mg per capsule) depending on the randomization sequence assigned by the Investigational Pharmacy Services. Capsules will be administered with 240 ml of room temperature water which the subjects will be asked to drink in its entirety. Subjects will remain in a fasted state for 4 additional hours following administration of either formulation to eliminate any potential effect of food on absorption. Standard meals will be served to all subjects at least 4 hours post-dosing. The composition and amount of food eaten throughout the day will be recorded.
Blood sample collection and processing will be done by an indwelling venous catheter to facilitate serial blood sampling, a total of 9 blood samples (~10 ml each) will be taken over an 8-hour period during each of the two primary study days. Specific time points of blood collection will be immediately prior to the dose (0 time point), of either Product B® IsaGenesis® (2 capsules; 1280 mg per capsule) or IsaGenesis® (2 capsules; 1070 mg per capsule) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours.
This single dose assessment of the Product B® IsaGenesis® (2 capsules; 1280 mg per capsule) or IsaGenesis® (2 capsules; 1070 mg per capsule) pharmacokinetics will be conducted with each of the two described formulations as a single dose assessment in a randomized crossover fashion. Following the completion of the initially product administration and sample collection, a minimum 7-day wash-out period will occur prior to scheduling each subject's return for the assessment of the alternate product (under identical study conditions and collection times).
Study Exit Visit The investigators will have the subjects return within 7 days of completing the second study formulation pharmacokinetics assessment to have "exit" follow-up lab work consisting of a basic serum chemistry panel and CBC as well as urinalysis.
- Conditions
- Healthy
- Being tested
- Product B® IsaGenesis®, IsaGenesis®
- Keywords
- dietary supplement, pharmacokinetics, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product B® IsaGenesis®Dietary supplement
Also called milk thistle extract
This will be a crossover comparison of a one time dose of the liquid-gel formulation contained in 2 capsules; 1280 mg/capsule.
IsaGenesis®Dietary supplement
Also called milk thistle extract
This will be a crossover comparison of a one time dose of the dried powder extract contained in 2 capsules; 1070 mg /capsule.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Product B® IsaGenesis®; Dietary Supplement: IsaGenesis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of Product B® IsaGenesis® versus IsaGenesis®
Measured: 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®
Measured: 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®
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Isagenix International LLC
- Responsible party
- Sponsor
- Investigators
- John S Markowitz, Pharm.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529605
- Sponsor's protocol ID
- IRB201500360
- Status last verified
- Jun 2018
- First submitted
- 17 Aug 2015
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29273470
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Two Different Milk Thistle Formulations: A Single Dose Randomized Crossover Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT02529605
- Acronym / sponsor ID
- IRB201500360
- Conditions
- Healthy
- Keywords
- dietary supplement, pharmacokinetics, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Isagenix International LLC
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study involves a total of five (5) visits to the University of Florida Shands CRC located in the Clinical Translational Research Building in Gainesville, and is expected to last approximately 6 weeks.
Screening / Informed Consent:
The Screening Visit will be conducted in the CRC and is expected to last approximately 1 hour.
After obtaining written Informed Consent, study subjects will be interviewed about their medical history and the protocol's Inclusion/Exclusion criteria will be discussed. All potential participants must be nonsmokers, not taking prescription or over-the-counter medications or botanical/nutritional supplements (inclusive of vitamins). Additionally, participants are requested to abstain from alcohol use 24 hours prior to the study health screen lab work or any scheduled study visit should they participate fully in the study.
During this initial visit, interested subjects will have blood samples drawn for health screening purposes including baseline serum chemistries, complete blood count, urinalysis, and a urine pregnancy test (women) which will precede a subsequently scheduled physical exam and possible study participation. Copies of the laboratory results will be made available to study subjects at their request. Lastly, a 12-lead electrocardiogram will be obtained.
Study Visits The following section describes the study procedures for the two major study visits at the CRC following Informed Consent and a satisfactory medical screening.
Following an overnight fast (abstention from eating any food items after 9 pm in the evening prior to the scheduled visit), subjects will arrive at the CRC the morning of the active Study Days where they will remain for approximately 8 hours on each day. After checking in, and under medical supervision, skilled CRC staff will place an indwelling venous catheter in each subject's arm to facilitate serial blood sampling. Female subjects will provide a urine sample for a pregnancy test. At approximately 8:00 AM subjects will be administered 2 capsules of either Product B® IsaGenesis® (2 capsules; 1280 mg per capsule) or IsaGenesis® (2 capsules; 1070 mg per capsule) depending on the randomization sequence assigned by the Investigational Pharmacy Services. Capsules will be administered with 240 ml of room temperature water which the subjects will be asked to drink in its entirety. Subjects will remain in a fasted state for 4 additional hours following administration of either formulation to eliminate any potential effect of food on absorption. Standard meals will be served to all subjects at least 4 hours post-dosing. The composition and amount of food eaten throughout the day will be recorded.
Blood sample collection and processing will be done by an indwelling venous catheter to facilitate serial blood sampling, a total of 9 blood samples (~10 ml each) will be taken over an 8-hour period during each of the two primary study days. Specific time points of blood collection will be immediately prior to the dose (0 time point), of either Product B® IsaGenesis® (2 capsules; 1280 mg per capsule) or IsaGenesis® (2 capsules; 1070 mg per capsule) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours.
This single dose assessment of the Product B® IsaGenesis® (2 capsules; 1280 mg per capsule) or IsaGenesis® (2 capsules; 1070 mg per capsule) pharmacokinetics will be conducted with each of the two described formulations as a single dose assessment in a randomized crossover fashion. Following the completion of the initially product administration and sample collection, a minimum 7-day wash-out period will occur prior to scheduling each subject's return for the assessment of the alternate product (under identical study conditions and collection times).
Study Exit Visit The investigators will have the subjects return within 7 days of completing the second study formulation pharmacokinetics assessment to have "exit" follow-up lab work consisting of a basic serum chemistry panel and CBC as well as urinalysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product B® IsaGenesis®, Then IsaGenesis® | Active comparator | Dietary Supplement: Product B® IsaGenesis®, Dietary Supplement: IsaGenesis®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. |
| IsaGenesis®, Then Product B® IsaGenesis® | Active comparator | Dietary Supplement: Product B® IsaGenesis®, Dietary Supplement: IsaGenesis®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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
- A positive urine pregnancy test.
- Any concomitant prescription medication, over-the-counter medication, herbal or other supplements, and vitamins during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product B® IsaGenesis®Also: milk thistle extractThis 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®, Then Product B® IsaGenesis®, Product B® IsaGenesis®, Then IsaGenesis® |
| IsaGenesis®Also: milk thistle extractThis will be a crossover comparison of a one time dose of the dried powder extract contained in 2 capsules; 1070 mg /capsule. | Dietary supplement | IsaGenesis®, Then Product B® IsaGenesis®, Product B® IsaGenesis®, Then IsaGenesis® |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of Product B® IsaGenesis® versus IsaGenesis®
Time frame: 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®
Time frame: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose
1 secondary outcome
Number of Participants With Response to Product B® Isagenesis® versus IsaGenesis®
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Derived from this study: PubMed 29273470Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Markowitz, Pharm.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product B® IsaGenesis® and IsaGenesis® in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of Product B® IsaGenesis® versus IsaGenesis® (time frame: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.