Influence of Luteolin for Two Weeks on Memory in Healthy Subjects

NCT06047899 | Completed

• 1 other identifier: 2023-01628
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory

Outcome Measures

Primary Outcomes (1)

• Visual Memory Test

  Performance in a visual memory test (Rey-Osterrieth complex figure test (Rey 1941) and (Osterrieth 1944)). As parallel version we will use the modified complex Taylor figure test (Hubley 2002). Participants will have to copy the complex figure. After a short delay of 5 minutes, they will be asked to redraw the figure from memory. A long-delayed recall test will be administered 2 weeks after the learning phase. 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.

  short delay (5 minutes), long delay (14 days): to assess differences between these time points

Secondary Outcomes (6)

• Verbal Memory Task

  immediate recall, short delay (10 minutes), long delay (14 days): to assess differences between these time points

• Working Memory Test

  after each treatment phase (duration two weeks)

• Mood State (MDBF)

  after each treatment phase (duration two weeks)

• Depressive Symptoms

  after each treatment phase (duration two weeks)

• Anxiety

  after each treatment phase (duration two weeks)

Study Arms (2)

Intervention

EXPERIMENTAL

In the intervention phase we will administer 500 mg luteolin (2x250 mg capsules, e.g. every morning and evening) per day formulated for oral administration for 14.5 days.

Dietary Supplement: Luteolin

Placebo

PLACEBO COMPARATOR

Placebo 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 14.5 days.

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).

Intervention

Placebo OTHER

mannitol formulated for oral administration (capsules)

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: 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, Prof

  University of Basel

  STUDY CHAIR

• Christiane Gerhards, 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: SPONSOR INVESTIGATOR
• PI Title: Director Division of Cognitive Neuroscience

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

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: November 28, 2023
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CH (1)