CompletedNot Applicable

Chrysin Bioavailability and Safety

Canada18 participantsStarted 2024-12-05

Plain-language summary

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.

Who can participate

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cmax: maximum plasma concentration

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT07066839

SponsorIsura

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-21

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