Influence of Luteolin on Memory in Healthy Subjects

NCT04468854 | Terminated

• 1 other identifier: 2019-01356
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory

Outcome Measures

Primary Outcomes (2)

• Visual Memory Test

  Performance in a visual memory test (Rey-Osterrieth complex figure test (Rey 1941) and (Osterrieth 1944)). As parallel version the modified complex Taylor figure test (Hubley 2002). Participants will have to copy the complex figure of Rey Osterrieth. After 3 and 20 minutes delay the subject will be asked to draw the figure from memory. 7 days after learning there will be a delayed recall. Performance is calculated by scoring for accuracy and relative position of the 18 units in the whole of the design. Maximal score is 36 points.

  after 3 minutes, short delay (20 minutes), long delay (7 days): to assess differences between these time points

• Verbal Memory Task

  Verbal memory task (de Quervain, Roozendaal et al. 2000). A parallel version will be used for the second study phase. Subjects will view series of 60 unrelated German nouns each presented for 4 s on a computer screen with the explicit instruction to learn them for immediate and delayed recall. For the free-recall test, subjects will be asked to write down all the words they remember. The number of correctly recalled words (hits) will be the relevant output. Delayed recall of all 60 words will be tested about 15 min (short delay) and 7 days (long delay, after treatment phase) after presentation.

  immediate recall, short delay (15 minutes), long delay (7 days): to assess differences between these time points

Secondary Outcomes (6)

• Digit Span Task

  after each treatment phase (duration one week) on vists 2 and 4

• Mode state (MDBF)

  after each treatment phase (duration one week) on vists 2 and 4

• Depressive symptoms

  after each treatment phase (duration one week) on vists 2 and 4

• Anxiety

  after each treatment phase (duration one week) on vists 2 and 4

• Visual Analog Scales Subjective Memory Function

  after each treatment phase (duration one week) on vists 2 and 4

Study Arms (2)

Experimental intervention

EXPERIMENTAL

In the experimental phase we 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.

Dietary Supplement: Luteolin

Control Intervention

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Luteolin DIETARY_SUPPLEMENT

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).

Experimental intervention

Placebo OTHER

mannitol formulated for oral administration (capsules)

Control Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Basel: lead

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Interventions

Luteolin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dominique de Quervain, MD

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Divicion of Cognitive Neuroscience

Model Details: * randomized * double-blind * placebo-controlled * cross-over * counter-balanced

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 13, 2020
• Study Start: January 1, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

CH (1)