Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06796374

A Comparison of Fisetin Kinetics in Young and Old Adults

Led by University Medicine Greifswald · Updated on 2026-04-06

80

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Comparison of Fisetin Kinetics in Young and Old Adults

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any sex
  • Age between 18 and 30 years or 65 years and older
  • Understands the study purpose and design
  • Contractually capable and provides signed informed consent
  • Healthy or with mild and/or well-treated allergies, asthma, hypertension, or orthopedic diseases
  • Taking a maximum of 3 chronic medications
Not Eligible

You will not qualify if you...

  • Body mass index over 30 or under 18 kg/m2
  • Body weight less than 48 kg
  • Women in young cohort who are pregnant or breastfeeding, or have positive pregnancy test at screening or kinetic visit
  • Men with hemoglobin less than 8.3 mmol/l or women with hemoglobin less than 7.3 mmol/l
  • Elevated liver function tests above twice the upper limit of normal
  • Reduced kidney function (eGFR less than 60 ml/min/1.7 m2)
  • QTcF over 450 ms in screening ECG
  • Recent or current psychiatric disease requiring treatment
  • Current drug dependency
  • Recreational drug use more than twice a week
  • Known allergy or hypersensitivity to fisetin
  • History of severe allergic reactions or anaphylaxis
  • Poor veins preventing blood sampling
  • Recent intake of drugs extensively metabolized by certain enzymes or with narrow therapeutic range within past 7 days
  • Recent intake of COMT inhibitors within past 7 days
  • Recent intake of fisetin-containing drugs or supplements within 2 days before or during kinetic visits
  • Consumption of high fisetin foods within 2 days before kinetic visits (e.g. strawberry, apple, persimmon, grape, mango, kiwi, peach, tomato, onion, lotus roots, kale, cucumber, or related processed products like wine)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Clinical Pharmacology, Institute of Pharmacology at the Center of Drug Absorption and Transport (C_DAT), University Medicine Greifswald

Greifswald, Germany

Actively Recruiting

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Research Team

S

Stefan Engeli, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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