Chrysin Bioavailability and Safety

Isura

Status: Completed

Conditions: Safety After Oral Intake; Bioavailability and Pharmacokinetics

Treatments: Dietary Supplement: LipoMicel Chrysin; Dietary Supplement: Non-Micellar Chrysin; Dietary Supplement: Standard/Unformulated Chrysin

Study type: Interventional

Funder types: Other

Identifiers

NCT07066839

2022-11-002CR

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups

LipoMicel Chrysin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: LipoMicel Chrysin

Non-micellar Chrysin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Non-Micellar Chrysin

Standard Unformulated Chrysin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Standard/Unformulated Chrysin