Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2024-05-01
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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LipoMicel Milk Thistle
Participants receive their treatment of a novel micellar Milk Thistle formulation (i.e, LipoMicel soft-gel capsules) at a total dose of approx. 140 mg of silymarins per capsule. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used.
LipoMicel Milk Thistle
A maximum single dose of approx. 140 mg silymarin (in soft gel capsule)
Unformulated/Standard Milk Thistle Extract
Participants receive their treatment of standard/unformulated Milk Thistle (i.e, hard-gel capsules) at a total dose of approx. 130 mg of silymarins per capsule. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used.
Unformulated Milk Thistle Extract
A maximum single dose of approx. 130 mg silymarin (in hard gel capsules)
Interventions
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LipoMicel Milk Thistle
A maximum single dose of approx. 140 mg silymarin (in soft gel capsule)
Unformulated Milk Thistle Extract
A maximum single dose of approx. 130 mg silymarin (in hard gel capsules)
Eligibility Criteria
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Inclusion Criteria
* Healthy, good physical condition
* Voluntary, written, informed consent to participate in the study.
Exclusion Criteria
* Contraindication or allergies to milk thistle
* Pregnancy or breastfeeding
* Concurrent use of supplements and/or medications
* Participation in another investigational study
21 Years
65 Years
ALL
Yes
Sponsors
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Isura
OTHER
Responsible Party
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Principal Investigators
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Julia Solnier, PhD
Role: PRINCIPAL_INVESTIGATOR
Isura
Locations
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ISURA
Burnaby, British Columbia, Canada
Countries
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Other Identifiers
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2022-11-002S
Identifier Type: -
Identifier Source: org_study_id
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