Clinical trial NCT06047899: Influence of Luteolin for Two Weeks on Memory in Healthy Subjects
Official title: Influence of the Dietary Supplement Luteolin for Two Weeks on Memory in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized double-blind placebo-controlled cross-over counter-balanced
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about the effect of the dietary supplement luteolin in healthy people. The main question it aims to answer is: Does luteolin have an influence on memory functions?

Participants will go trough two treatment phases. In one phase they will take 250mg luteolin twice daily for two weeks. In the other phase they will take a placebo twice daily for two weeks. A placebo is a look-alike substance that contains no active drug.

At the start and end of teach treatment phase, participants will undergo different memory testing exercises in our research facility.


Eligibility criteria: Inclusion Criteria:

* healthy
* male or female
* able to give written informed consent as documented by signature
* Aged: 18 to 40 years
* normotensive (BP 90/60mmHg to 140/90mmHg)
* BMI ≤ 30 kg/m2

Exclusion Criteria:

* bodyweight \<50 kg
* pregnant or lactating women
* intention to become pregnant during the course of the study
* known or suspected non-compliance, drug or alcohol abuse
* MADRS-S total score \> 12 or MADRS-S item 9 \>1
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders
* participation in another study with investigational drug within the 30 days preceding and during the present study
* participation in one of our previous studies using the same memory tests in the past 2 years or participation in our first luteolin study in 2020
* enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: Visual Memory Test
timeFrame: short delay (5 minutes), long delay (14 days): to assess differences between these time points
Secondary outcomes:
measure: Verbal Memory Task
timeFrame: immediate recall, short delay (10 minutes), long delay (14 days): to assess differences between these time points
measure: Working Memory Test
timeFrame: after each treatment phase (duration two weeks)
measure: Mood State (MDBF)
timeFrame: after each treatment phase (duration two weeks)
measure: Depressive Symptoms
timeFrame: after each treatment phase (duration two weeks)
measure: Anxiety
timeFrame: after each treatment phase (duration two weeks)
measure: Visual Analog Scales Quality of Sleep
timeFrame: after each treatment phase (duration two weeks)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
state: Basel-Stadt
Study officials:
affiliation: University of Basel
name: Dominique de Quervain, Prof
role: STUDY_CHAIR
affiliation: University of Basel
name: Christiane Gerhards, MD
role: PRINCIPAL_INVESTIGATOR
References: