Influence of Luteolin for Two Weeks on Memory in Healthy Subjects (LuMus2-2023)

Prof. Dominique de Quervain, MD

Status: Completed

Conditions: Memory

Treatments: Other: Placebo; Dietary Supplement: Luteolin

Study type: Interventional

Funder types: Other

Identifiers

NCT06047899

2023-01628

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

44 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Luteolin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo