Safety and Pharmacokinetics of an Extract of Naringenin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-25

Study Completion Date

2018-09-28

Brief Summary

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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.

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Detailed Description

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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

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Safety Issues Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study consists of two cohorts of nine subjects each. In the first cohort subjects will receive the 150 mg dose and proceed to the 300 mg dose only if the 150 mg dose is deemed safe. The study is a double blind randomized controlled crossover trial, therefore, subjects could receive a placebo at the first or second visit. Similarly in the second cohort, 600 mg and 900 mg doses will be evaluated.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Except for the pharmacist who will prepare and dispense the capsules, all study staff and the investigators will be blinded to the randomization.

Study Groups

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150 mg dose

Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 150 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin.

Group Type EXPERIMENTAL

Naringenin

Intervention Type DIETARY_SUPPLEMENT

An extract of Citrus Sinensis containing naringenin and its precursor naringin

300 mg dose

Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 300 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin.

Group Type EXPERIMENTAL

Naringenin

Intervention Type DIETARY_SUPPLEMENT

An extract of Citrus Sinensis containing naringenin and its precursor naringin

600 mg dose

Blood will be drawn at at 0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours to measure serum naringenin concentrations in response to a single 600 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin.

Group Type EXPERIMENTAL

Naringenin

Intervention Type DIETARY_SUPPLEMENT

An extract of Citrus Sinensis containing naringenin and its precursor naringin

900 mg dose

Blood will be drawn at at 0, and 4 hours to measure serum naringenin concentrations in response to a single 900 mg oral dose of an extract of Citrus sinensis (sweet orange) containing naringenin and its precursor naringin.

Group Type EXPERIMENTAL

Naringenin

Intervention Type DIETARY_SUPPLEMENT

An extract of Citrus Sinensis containing naringenin and its precursor naringin

Placebo

Subjects in the first cohort will receive 150 mg and 300 mg ascending doses of naringenin and subjects in the second cohort will receive 600 mg and 900 mg ascending doses of naringenin. Each cohort will also have a placebo group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Cellulose

Interventions

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Naringenin

An extract of Citrus Sinensis containing naringenin and its precursor naringin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Cellulose

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes