Chrysin Bioavailability and Safety

NCT07066839 | Completed

• 1 other identifier: 2022-11-002CR
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability and Pharmacokinetics; Safety After Oral Intake

Keywords

chrysin; pharmacokinetics; bioavailability; micellar delivery; natural health products; caco-2 permeability; safety; dietary supplements

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

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

Secondary Outcomes (11)

• Alanine aminotransferase (ALT)

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

• Aspartate aminotransferase (AST)

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

• Total bilirubin (TB)

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

• Serum creatinine

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

• Glomerular filtration rate (GFR)

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

Study Arms (3)

LipoMicel Chrysin

EXPERIMENTAL

Each participant receives their treatment i.e., LipoMicel Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used.

Dietary Supplement: LipoMicel Chrysin

Non-micellar Chrysin

EXPERIMENTAL

Each participant receives their treatment i.e., Non-Micellar Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used.

Dietary Supplement: Non-Micellar Chrysin

Standard Unformulated Chrysin

EXPERIMENTAL

Each participant receives their treatment i.e., Standard Unformulated Chrysin at a total dose of 1000 mg chrysin. Treatments are consumed with a glass of water (approx. 200mL), followed by a standardized breakfast (diet-controlled condition) 2 hours post-dose. Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 7 days between each treatment is used.

Dietary Supplement: Standard/Unformulated Chrysin

Interventions

LipoMicel Chrysin DIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

LipoMicel Chrysin

Non-Micellar Chrysin DIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Non-micellar Chrysin

Standard/Unformulated Chrysin DIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Standard Unformulated Chrysin

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female aged 21-65 years
• healthy, good physical condition
• voluntary, written, informed consent to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isura: lead

Study Sites (1)

ISURA

Burnaby, British Columbia, Canada

Location

Study Officials

• Julia Solnier, PhD

  Isura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of LipoMicel Chrysin intervention with the higher bioavailability is evaluated in a subsequent single-arm, 30-day trial.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: December 5, 2024
• Primary Completion: February 21, 2025
• Study Completion: April 2, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)