A Comparison of Fisetin Kinetics in Young and Old Adults

NCT06796374 | Not Yet Recruiting

• 1 other identifier: IPHA-2025-010
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pharmacokinetic Study in Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 (AUC0-24h).

  24 hours

• 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 (AUC0-24h).

  24 hours

Secondary Outcomes (30)

• Fisetin metabolites plasma concentration arm 1 vs. arm 2

  24 hours

• Fisetin metabolites plasma concentration arm 3 vs. arm 4

  24 hours

• Fisetin plasma concentration arm 1 vs. arm 2

  24 hours

• Fisetin plasma concentration arm 3 vs. arm 4

  24 hours

• Fisetin plasma concentration arm 1 vs. arm 2

  24 hours

Study Arms (4)

Arm 2: Fisetin - Cohort 2: old age (≥ 65 years)

ACTIVE COMPARATOR

Dietary Supplement: Fisetin

Arm 4: Fisetin + Quercetin - Cohort 2: old age (≥ 65 years)

ACTIVE COMPARATOR

Dietary Supplement: Fisetin + Quercetin

Arm 1: Fisetin - Cohort 1: young age (18-30 years)

ACTIVE COMPARATOR

Dietary Supplement: Fisetin

Arm 3: Fisetin + Quercetin - Cohort 1: young age (18-30 years)

ACTIVE COMPARATOR

Dietary Supplement: Fisetin + Quercetin

Interventions

Fisetin DIETARY_SUPPLEMENT

A single oral dose of 100 mg fisetin (as Novusetin®) will be administered as 1 capsule with 240 ml of still water in the overnight fasting condition: A total of 18 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; 4.0; 5.0; 6.0; 8.0; 10.0; 24.0 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 90 ml at the kinetic visits and 12 ml at the screening visit. Urine will be collected during the first 10 hours after fisetin administration.

Arm 1: Fisetin - Cohort 1: young age (18-30 years); Arm 2: Fisetin - Cohort 2: old age (≥ 65 years)

Fisetin + Quercetin DIETARY_SUPPLEMENT

A single oral dose of 1000 mg fisetin + 200 mg quercetin will be administered as 2 softgel capsule with 240 ml of still water in the overnight fasting condition: A total of 18 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; 4.0; 5.0; 6.0; 8.0; 10.0; 24.0 h). At each time point, blood will be collected (4.9 ml for separation of plasma) to determine fisetin, fisetin metabolites, and quercetin. The total amount of blood collected for each participant and each arm is 90 ml at the kinetic visits and 12 ml at the screening visit. Urine will be collected during the first 10 hours after fisetin administration.

Arm 3: Fisetin + Quercetin - Cohort 1: young age (18-30 years); Arm 4: Fisetin + Quercetin - Cohort 2: old age (≥ 65 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• healthy condition or mild and/or well-treated forms of allergies, asthma, hypertension, and orthopedic diseases
• a maximum of 3 chronically taken drugs

You may not qualify if:

• 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 \< 13 g/dl (8,07 mmol/l) women: hemoglobin \< 12 g/dl (7,45 mmol/l)
• elevated liver function tests (1 or more of ALAT, ASAT, yGT, Bilirubin \> 2x ULN)
• reduced renal function (eGFRMDRD \< 60 ml/min/1,7 m2)
• QTcF \> 450 ms in screening ECG
• psychiatric disease requiring recent or actual treatment
• drug dependency at the time of visit
• use of recreational drugs more than twice a week
• any known hypersensitivity or allergic reactions to fisetin
• history of severe hypersensitivity reactions and/or anaphylaxis
• poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
• intake of drugs interfering with CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and/or Pgp during the past seven days if the duration of intake was at least two days
• individuals who have eaten food with high fisetin content in the two days before the kinetic visits (e.g. strawberry, apple, persimmon, grape, mango, kiwi, peach, tomato, onion, lotus roots, kale, cucumber; processed products, e.g. wine)

Sponsors & Collaborators

• University Medicine Greifswald: lead

MeSH Terms

Interventions

fisetin; Quercetin

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Stefan Engeli, Prof.

CONTACT

+49 3834 86 56 33; stefan.engeli@med.uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an opel-label study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The kinetic study will be designed as an open-label, two-cohorts (young vs. old), four-arm, randomized cross-over, single oral dose protocol.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share