Safety and Pharmacokinetics of an Extract of Naringenin

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.

Inclusion criteria

• Adult (≥18 years)
• Body mass index between 20 and 35 kg/m2
• Must have fasting blood sugar <126 mg/dL)
• Must be willing to refrain from consuming citrus fruits and tomato in any form, for 36 hours prior to each test day.

Exclusion criteria

• Report citrus allergies.
• Report a history of cardiovascular disease, diabetes, or cancer
• Have evidence of hepatic disease or dysfunction
• Are currently pregnant or breastfeeding
• Are women of childbearing potential who will not use an effective method of birth control
• Chronically use of medications except over the counter medications that have been stopped 72 hours prior to the study visit
• Report clinically significant GI malabsorption syndromes
• Have clinically significant abnormal laboratory markers
• Anticipate surgery during the study period.
• Report history of substance abuse or alcoholism or significant psychiatric disorder that would interfere with the ability to complete the study.
• Have donated blood during the month prior to study entry or plan to do so during the study.
• Have participated in other studies using an investigational drug during the preceding three months.
• Are current smokers or have smoked within the previous three months.