Relative Bioavailability of Two Different Milk Thistle Formulations
Completed · Not applicable
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02529605
- Run by
- University of Florida
- People needed
- 12
- Starts
- 2015-09-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2018-06-19
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Uf Ctsi Crc — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.