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A Comparison of Fisetin Kinetics in Young and Old Adults

ConditionPharmacokinetic Study in Healthy Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medicine Greifswald

About this trial

This study investigates the differences in the kinetic parameters of fisetin in two cohorts of healthy volunteers:

Cohort 1) volunteers aged 18-30 years (n = 40) Cohort 2) volunteers aged 65 years or older (n = 40)

The purpose of this study is:

1. To describe the fisetin kinetics after a single dose oral administration in older age. 2. To compare the fisetin kinetics after a single dose oral administration in old and young age.

FISEKIN-1 is designed as a four-arm study protocol. As well as two different age groups (18-30 years vs. 65 years and older), we want to compare fisetin kinetic parameters in fasted and fed condition:

Arm 1) 500 mg fisetin (1x 5 capsule), fasted condition, cohort 1: young age Arm 2) 500 mg fisetin (1x 5 capsule), fasted condition, cohort 2: old age Arm 3) 500 mg fisetin (1x 5 capsule), fed condition, cohort 1: young age Arm 4) 500 mg fisetin (1x 5 capsule), fed condition, cohort 2: old age

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

any sex

age between 18 and 30 years or ≥ 65 years

understands the study purpose and design

contractually capable and provides signed informed consent form

Disqualifiers

BMI > 30 kg/m2 and < 18 kg/m2

body weight < 48 kg

women in young cohort: known pregnancy or lactation period; positive urine pregnancy test at screening or kinetic visit

men: hemoglobin < 8,3 mmol/l women: hemoglobin < 7,3 mmol/l

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fisetin - Fasted condition

    Dietary supplement

    A single oral dose of 500 mg fisetin (as Novusetin®) will be administered as 5 capsules with 240 ml of still water in the overnight fasting condition: A total of 24 blood samples will be taken at defined time points (baseline; 10; 20; 30; 40; 50; 60; 80; 100 min; 2.0; 2.5; 3.0; 3.5; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 9.0; 10.0 h). At each time point, blood will be collected (4.9 ml for separation of plasma) to determine fisetin, and fisetin metabolites. The total amount of blood collected for each participant and each arm is 164 ml at the kinetic visits and 12 ml at the screening visit. Urine will be collected during the first 10 hours after fisetin administration.

  • Fisetin - Fed condition

    Dietary supplement

    A single oral dose of 500 mg fisetin (as Novusetin®) will be administered as 5 capsules with 240 ml of still water in fed condition: Participants will eat a high-caloric and high-fat meal based on the recommendation of the FDA (Food and Drug Administration) for food-effect studies. This meal will contain two slices of toast with butter, two eggs fried in butter, approx. 113 g hash brown potatoes and 240 ml whole milk. A total of 24 blood samples will be taken at defined time points (baseline; 10; 20; 30; 40; 50; 60; 80; 100 min; 2.0; 2.5; 3.0; 3.5; 4.0; 4.5; 5.0; 5.5; 6.0; 6.5; 7.0; 7.5; 8.0; 9.0; 10.0 h). At each time point, blood will be collected (4.9 ml for separation of plasma) to determine fisetin, and fisetin metabolites. The total amount of blood collected for each participant and each arm is 164 ml at the kinetic visits and 12 ml at the screening visit. Urine will be collected during the first 10 hours after fisetin administration.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Arm 2: Fisetin, fasted condition - Cohort 2: old age (≥ 65 years)Active comparator 1 intervention
Group B: Arm 4: Fisetin, fed condition - Cohort 2: old age (≥ 65 years)Active comparator 1 intervention
Group C: Arm 1: Fisetin, fasted condition - Cohort 1: young age (18-30 years)Active comparator 1 intervention
Group D: Arm 3: Fisetin, fed condition - Cohort 1: young age (18-30 years)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fisetin plasma concentration arm 1 vs. arm 2

Difference of fisetin plasma concentrations between the young and old cohort, expressed as area under the curve (AUC0-10h).

Time frame
10 hours
2

Fisetin plasma concentration arm 3 vs. arm 4

Difference of fisetin plasma concentrations between the young and old cohort, expressed as area under the curve (AUC0-10h).

Time frame
10 hours

Secondary outcomes

1

Fisetin metabolites plasma concentration arm 1 vs. arm 2

Difference in plasma concentrations of fisetin metabolites between the young and old cohort, expressed as area under the curve (AUC0-10h).

Time frame
10 hours
2

Fisetin metabolites plasma concentration arm 3 vs. arm 4

Difference in plasma concentrations of fisetin metabolites between the young and old cohort, expressed as area under the curve (AUC0-10h).

Time frame
10 hours
3

Fisetin plasma concentration arm 1 vs. arm 2

Difference plasma concentrations of fisetin and fisetin metabolites between the young and old cohort, expressed as maximum plasma concentration (Cmax).

Time frame
10 hours
4

Fisetin plasma concentration arm 3 vs. arm 4

Difference in plasma concentrations of fisetin and fisetin metabolites between the young and old cohort, expressed as maximum plasma concentration (Cmax).

Time frame
10 hours

Other outcomes

Sponsors and contacts

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University Medicine Greifswald

Lead sponsor

Source ClinicalTrials.gov
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