Chrysin Bioavailability and Safety

NCT ID: NCT07066839

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Bioavailability and Pharmacokinetics Safety After Oral Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LipoMicel Chrysin

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.

Group Type EXPERIMENTAL

LipoMicel Chrysin

Intervention Type DIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Non-micellar Chrysin

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.

Group Type EXPERIMENTAL

Non-Micellar Chrysin

Intervention Type DIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Standard Unformulated Chrysin

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.

Group Type EXPERIMENTAL

Standard/Unformulated Chrysin

Intervention Type DIETARY_SUPPLEMENT

A maximum single oral dose of 1000 mg chrysin

Interventions

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LipoMicel Chrysin

A maximum single oral dose of 1000 mg chrysin

Intervention Type DIETARY_SUPPLEMENT

Non-Micellar Chrysin

A maximum single oral dose of 1000 mg chrysin

Intervention Type DIETARY_SUPPLEMENT

Standard/Unformulated Chrysin

A maximum single oral dose of 1000 mg chrysin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isura

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Solnier, PhD

Role: PRINCIPAL_INVESTIGATOR

Isura

Locations

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ISURA

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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2022-11-002CR

Identifier Type: -

Identifier Source: org_study_id

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