Chrysin Bioavailability and Safety

Isura18 enrolled

Overview

This study seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement. The study also seeks to determine the short-term effects and safety of daily oral supplementation of LipoMicel Chrysin in healthy adult volunteers over a 30-day study period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bioavailability and Pharmacokinetics Safety After Oral Intake

Interventions

LipoMicel ChrysinDIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Non-Micellar ChrysinDIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Standard/Unformulated ChrysinDIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * male or female aged 21-65 years * healthy, good physical condition * voluntary, written, informed consent to participate in the study. Exclusion Criteria: * use of anti-inflammatory or non-steroidal anti-inflammatory drugs * previous history of cardiovascular disease or acute or chronic inflammatory disease * use of antioxidant or polyphenol supplements or cholesterol-lowering agents * change of diet habits or lifestyle (diet, physical activity, etc.) * alcohol or substance abuse history * use of nicotine or tobacco * participation in another investigational study

Locations (1)

ISURA

Burnaby, British Columbia, Canada

Outcomes

Primary Outcomes

Cmax: maximum plasma concentration

To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing chrysin.

Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]

AUC: the area under the concentration-time curve

To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing chrysin.

Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]

Tmax: the time point of maximum plasma concentration

To determine the gastrointestinal absorption of orally ingested chrysin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax)

Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)]

Secondary Outcomes

Alanine aminotransferase (ALT)

To evaluate changes in liver function based on ALT.

Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]

Aspartate aminotransferase (AST)

To evaluate changes in liver function based on AST.

Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]

Total bilirubin (TB)

To evaluate changes in liver function based on total bilirubin.

Time frame: [Time Frame: 0 (baseline; pre-dose), week 1, week 2, week 3 and week 4 (post-dose)]

Data from ClinicalTrials.gov

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