NCT03582553

Safety and Pharmacokinetics of an Extract of Naringenin

Clinical Safety and Pharmacokinetic Evaluation of Naringenin: Single Dose Escalation Randomized Double Blind Controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.

Detailed description

Naringenin is a component of food with therapeutic potential to improve glucose metabolism. In order to explore the mechanisms by which naringenin may increase energy expenditure and improve glucose metabolism in humans, it is of vital importance that the safety, tolerability, and bioavailability of naringenin are evaluated, when administered to humans. This study tests the safety of four doses of a citrus extract of naringenin and measures serum concentrations of naringenin at the 150 mg and 600 mg doses over a period of 24 hours, and at the 300 and 900 mg doses at four hours after subjects have been given the respective doses of naringenin.

Conditions

• Safety Issues
• Pharmacokinetics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Naringenin	An extract of Citrus Sinensis containing naringenin and its precursor naringin
OTHER	Placebo	Cellulose

Timeline

• Start date: 2018-05-25
• Primary completion: 2018-09-28
• Completion: 2018-09-28
• First posted: 2018-07-11
• Last updated: 2020-01-18
• Results posted: 2020-01-18

Locations

1 site across 1 country: United States