Influence of Luteolin on Memory in Healthy Subjects

NCT ID: NCT04468854

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-03-15

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.

Conditions

Memory

Study Design

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

Study Groups

Experimental intervention

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.

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).

Control Intervention

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.

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

• 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.

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

Sponsors

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dominique de Quervain, MD

Director Divicion of Cognitive Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique de Quervain, 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

2019-01356

Identifier Type: -

Identifier Source: org_study_id