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Completed

NCT Number: NCT07066839

Chrysin Bioavailability and Safety

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.

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Key information

Conditions

Bioavailability and Pharmacokinetics Safety After Oral Intake

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISURA

Burnaby, British Columbia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LipoMicel Chrysin

Dietary Supplement

A maximum single oral dose of 1000 mg chrysin

Non-Micellar Chrysin

Dietary Supplement

A maximum single oral dose of 1000 mg chrysin

Standard/Unformulated Chrysin

Dietary Supplement

A maximum single oral dose of 1000 mg chrysin

Primary outcomes

  1. Cmax: maximum plasma concentration

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

    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.

  2. AUC: the area under the concentration-time curve

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

    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.

  3. Tmax: the time point of maximum plasma concentration

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

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

Secondary outcomes

  1. Alanine aminotransferase (ALT)

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

    To evaluate changes in liver function based on ALT.

  2. Aspartate aminotransferase (AST)

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

    To evaluate changes in liver function based on AST.

  3. Total bilirubin (TB)

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

    To evaluate changes in liver function based on total bilirubin.

  4. Serum creatinine

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

    To evaluate changes in kidney function based on serum creatinine.

  5. Glomerular filtration rate (GFR)

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

    To evaluate changes in kidney function based on GFR.

  6. Fasting blood glucose

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

    To evaluate changes in blood glucose levels based on fasting blood glucose.

  7. HbA1c

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

    To evaluate changes in blood glucose levels based on HbA1c.

  8. Total cholesterol

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

    To evaluate changes in lipid profile based on total cholesterol.

  9. Triglycerides

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

    To evaluate changes in lipid profile based on triglycerides.

  10. Low-density lipoprotein (LDL) cholesterol

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

    To evaluate changes in lipid profile based on LDL.

  11. High-density lipoprotein (HDL) cholesterol

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

    To evaluate changes in lipid profile based on HDL.

Sponsors and collaborators

Lead sponsor

Isura

Other

Registry information

Official study title

Pharmacokinetics and Bioavailability of Three Chrysin Formulations in Healthy Adults

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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