MemoryLuMus-Basel 20NCT04468854
Influence of Luteolin on Memory in Healthy Subjects
A study testing Luteolin in people with Memory, run by University of Basel at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory
- What is being tested?
- Luteolin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Division of Cognitive Neuroscience
Basel, Canton of Basel-City, 4055
About this study
Official title: Influence of the Dietary Supplement Luteolin on Memory in Healthy Subjects
Proof of concept study on physiological processes (forgetting and memory functions, attention, working memory) in participants after multiple administration of the dietary supplement Luteolin.
Read the 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
- Being tested
- Luteolin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuteolinDietary 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).
PlaceboOther
mannitol formulated for oral administration (capsules)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediate recall, short delay (15 minutes), long delay (7 days): to assess differences between these time points
Secondary outcomes (6)
Digit Span Task
Performance in a Working memory test assessed by the digit span task, a subtest of the WIE (von Aster 2006). A parallel version will be used for each visit. Each correct reproduction of a sequence of numbers is scored with one point.
Measured: after each treatment phase (duration one week) on vists 2 and 4
Mode state (MDBF)
Mood state will be assessed for the past treatment phases of one week (visit 2 and 4) with the self-rating instrument MDBF (Steyer 1997) consisting of 12 items to be rated in a 5 scale mode. The total score is calculated by summing the answers in each of the 3 dimensions good/bad mood, alertness/sleepiness, rest /restlessness with 4 items in each dimension. We will use Version A and Version B.
Measured: after each treatment phase (duration one week) on vists 2 and 4
Depressive symptoms
Depressive symptoms will be assessed with the self-rating questionnaire MADRS-S (Schmidtke 1988) for the past week (treatment phases). This scale consists of 9 items assessing participants' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored between 0 and 3. The total score is calculated by summing the answers of the nine items, ranging between 0 and 27 (higher scores indicate increased impairment).
Measured: after each treatment phase (duration one week) on vists 2 and 4
Anxiety
Anxiety will be measured for the past treatment phases with the self-rating instrument STAI-G form X1 (state) (Laux 1981).This instrument consists of 20 items scored between 1-4. The total score is calculated by summing the answers, ranging between 20 and 80.
Measured: after each treatment phase (duration one week) on vists 2 and 4
Visual Analog Scales Subjective Memory Function
Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm) between the two end-points: better memory function respectively than normal or worse. The score ranges between -5 and + 5.
Measured: after each treatment phase (duration one week) on vists 2 and 4
Visual Analog Scales Quality of Sleep
Respondents specify their level of agreement to the statement by indicating a position along a continuous line (10 cm) between the two end-points: better sleep quality respectively than normal or worse. The score ranges between -5 and + 5.
Measured: after each treatment phase (duration one week) on vists 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jan 2020
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: Corona-Virus Lockdown (16th March in Switzerland)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- * randomized * double-blind * placebo-controlled * cross-over * counter-balanced
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, MD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468854
- Sponsor's protocol ID
- 2019-01356
- Other IDs
- 2019
- Acronym
- LuMus-Basel 20
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Dietary Supplement Luteolin on Memory in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04468854
- Acronym / sponsor ID
- LuMus-Basel 20 / 2019-01356
- Conditions
- Memory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corona-Virus Lockdown (16th March in Switzerland)
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * randomized * double-blind * placebo-controlled * cross-over * counter-balanced
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Dietary Supplement: LuteolinIn 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. |
| Control Intervention | Placebo comparator | Other: PlaceboControl 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male or female
- healthy
- normotensive (BP between 90/60mmHg and 140/90mmHg)
- BMI <30 kg/m2
- aged between 18 and 40 years
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuteolinLuteolin 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). | Dietary supplement | Experimental intervention |
| Placebomannitol formulated for oral administration (capsules) | Other | Control Intervention |
Primary outcome
Visual Memory Test
Time frame: after 3 minutes, short delay (20 minutes), long delay (7 days): to assess differences between these time points
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.
Verbal Memory Task
Time frame: immediate recall, short delay (15 minutes), long delay (7 days): to assess differences between these time points
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.
6 secondary outcomes
Digit Span Task
Time frame: after each treatment phase (duration one week) on vists 2 and 4
Mode state (MDBF)
Time frame: after each treatment phase (duration one week) on vists 2 and 4
Depressive symptoms
Time frame: after each treatment phase (duration one week) on vists 2 and 4
Anxiety
Time frame: after each treatment phase (duration one week) on vists 2 and 4
Visual Analog Scales Subjective Memory Function
Time frame: after each treatment phase (duration one week) on vists 2 and 4
Visual Analog Scales Quality of Sleep
Time frame: after each treatment phase (duration one week) on vists 2 and 4
Results and safety
The study was stopped early (reason given: Corona-Virus Lockdown (16th March in Switzerland)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique de Quervain, MD principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luteolin in people with Memory, run by University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Corona-Virus Lockdown (16th March in Switzerland)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Memory Test (time frame: after 3 minutes, short delay (20 minutes), long delay (7 days): to assess differences between these time points). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.