Clinical trial NCT04468854: Influence of Luteolin on Memory in Healthy Subjects
Official title: Influence of the Dietary Supplement Luteolin on Memory in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Memory
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 40
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: Proof of concept study on physiological processes (forgetting and memory functions, attention, working memory) in participants after multiple administration of the dietary supplement Luteolin.

Detailed description: In the experimental phase the investigator will administer 500 mg Luteolin (2x250 mg capsules) per day formulated for oral administration for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning). The last intake on visits 2 resp. 4 is important as the participants then have to recall the learned material from visits 1 resp. 3 during a steady-state status of Luteolin.

Subjects will be randomly allocated to treatment groups (starting with investigational product or placebo).

Identity of Investigational Product: Luteolin extracted from Chrysanthemum Ramat 98% HPLC by Scyherb® food grade certified according to Safe Quality Foods (SQF) - Level 3 Comprehensive Food Safety and Quality Management System Certification by the Safe Quality Food Institute (SQFI).

Control intervention consists of identical looking placebo capsules containing mannitol formulated for oral administration to be taken twice daily (e.g. every morning and evening) for 7.5 days (first intake: visit 1/3 in the morning; last intake: visit 2/4 in the morning) with water.

Eligibility criteria: Inclusion Criteria:

* male or female
* healthy
* normotensive (BP between 90/60mmHg and 140/90mmHg)
* BMI \<30 kg/m2
* aged between 18 and 40 years
* native or fluent German-speaking
* able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol

Exclusion Criteria:

* Bodyweight \<50 kg
* acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency)
* concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
* women who are pregnant or breast feeding
* intention to become pregnant during the course of the study
* known or suspected non-compliance, drug or alcohol abuse
* 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
* enrolment of the investigator, his/her family members, employees and other dependent persons
* participation in one of our previous studies using the same memory tests in the past 2 years
* Psychoactive drugs and alcoholic beverages 3 days (psychoactive drugs) resp. 12 hours (alcohol) before test visits 1-4.

Primary outcomes:
measure: Visual Memory Test
timeFrame: after 3 minutes, short delay (20 minutes), long delay (7 days): to assess differences between these time points
measure: Verbal Memory Task
timeFrame: immediate recall, short delay (15 minutes), long delay (7 days): to assess differences between these time points
Secondary outcomes:
measure: Digit Span Task
timeFrame: after each treatment phase (duration one week) on vists 2 and 4
measure: Mode state (MDBF)
timeFrame: after each treatment phase (duration one week) on vists 2 and 4
measure: Depressive symptoms
timeFrame: after each treatment phase (duration one week) on vists 2 and 4
measure: Anxiety
timeFrame: after each treatment phase (duration one week) on vists 2 and 4
measure: Visual Analog Scales Subjective Memory Function
timeFrame: after each treatment phase (duration one week) on vists 2 and 4
measure: Visual Analog Scales Quality of Sleep
timeFrame: after each treatment phase (duration one week) on vists 2 and 4
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
state: BS
Study officials:
affiliation: University of Basel
name: Dominique de Quervain, MD
role: PRINCIPAL_INVESTIGATOR
References: