Assessment of the bioavailability of phenolics from an orange peel extract

Assessment of the bioavailability of phenolics from an orange peel extract - Bioavailability of orange phenolics

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39992

Enrollment

Registered

2013-05-01

Start date

2013-04-22

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen aandoening, het onderzoek is gericht op biobeschikbaarheid bioavailability

Interventions

The study will consist of 3 study days in which each subject will consume in randomized order one of the three dosage forms containing the orange peel extract at the beginning of the test day.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-75y, generally healthy (i.e. no severe conditions based on medical assessment), non-smoking

Exclusion criteria

Exclusion criteria: current pregnancy, extreme BMI (25), clinically significant abnormal liver functioning, blood donation during the last 4 weeks prior to the first dosing

Design outcomes

Primary

Measure	Time frame
The primary aim of the study is to evaluate the bioavailability of hesperidin, the main flavonoid present in the orange peel extract, which was previously shown to have biological activity. Assessment and evaluation will be done by analyzing the plasma and urinary concentrations of the main study parameter: hesperidin and hesperitin in plasma and urine following a single oral consumption of the respective compositions and dosage forms. The main endpoint is the determination of the most effective dosage form of hesperidin. To do this, blood samples will be collected pre-dose and after 5, 15, 30 min, 1, 2, 3, 4, 6, 8, 10 and 24 h. Urine will be collected and pooled during the same time period.	—

Measure

Time frame

The primary aim of the study is to evaluate the bioavailability of hesperidin, the main flavonoid present in the orange peel extract, which was previously shown to have biological activity. Assessment and evaluation will be done by analyzing the plasma and urinary concentrations of the main study parameter: hesperidin and hesperitin in plasma and urine following a single oral consumption of the respective compositions and dosage forms. The main endpoint is the determination of the most effective dosage form of hesperidin. To do this, blood samples will be collected pre-dose and after 5, 15, 30 min, 1, 2, 3, 4, 6, 8, 10 and 24 h. Urine will be collected and pooled during the same time period.

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)