Silymarin Bioavailability Study

Isura

Status: Completed

Conditions: Bioavailability and Pharmacokinetics

Treatments: Dietary Supplement: Unformulated Milk Thistle Extract; Dietary Supplement: LipoMicel Milk Thistle

Study type: Interventional

Funder types: Other

Identifiers

NCT06882681

2022-11-002S

Details and patient eligibility

About

This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.

Enrollment: 16 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged 21- 65 years
• Healthy, good physical condition
• Voluntary, written, informed consent to participate in the study.

Exclusion criteria

• Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases
• Contraindication or allergies to milk thistle
• Pregnancy or breastfeeding
• Concurrent use of supplements and/or medications
• Participation in another investigational study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 2 patient groups

LipoMicel Milk Thistle

Experimental group

Description:

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.

Treatment:

Dietary Supplement: LipoMicel Milk Thistle

Unformulated/Standard Milk Thistle Extract

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Unformulated Milk Thistle Extract