A Comparison of Fisetin Kinetics in Young and Old Adults
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
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
Treatments tested in this trial
- Fisetin - Fasted condition
- Fisetin - Fed condition
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov