Influence of Luteolin for Two Weeks on Memory in Healthy Subjects

NCT ID: NCT06047899

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-28
• Study Completion Date: 2024-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Luteolin

Intervention Type: 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).

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

mannitol formulated for oral administration (capsules)

Interventions

Luteolin

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 Type: DIETARY_SUPPLEMENT

Placebo

mannitol formulated for oral administration (capsules)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Dominique de Quervain, MD

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Director Division of Cognitive Neuroscience

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dominique de Quervain, Prof

Role: STUDY_CHAIR

University of Basel

Christiane Gerhards, MD

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2023-01628

Identifier Type: -

Identifier Source: org_study_id