MemoryLuMus2-2023NCT06047899
Influence of Luteolin for Two Weeks on Memory in Healthy Subjects
A study testing Luteolin in people with Memory, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial 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. 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
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Nov 2023to 2 May 2024
- 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
- 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
Who cannot join
- 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
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- 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 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 for Two Weeks on Memory in Healthy Subjects
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
- 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 |
|---|---|---|
| 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. Receives: 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. 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 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.
Measured: short delay (5 minutes), long delay (14 days): to assess differences between these time points
Secondary outcomes (6)
Verbal Memory Task
Verbal memory task (de Quervain, Roozendaal et al. 2000). A parallel version will be used for the second study phase.
Subjects are given explicit instructions to learn 60 unrelated German nouns for immediate and delayed recall. For all free-recall tests (immediate recall, short delay and long delay), 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 10 min (short delay) and 2 weeks (long delay) after presentation.
Measured: immediate recall, short delay (10 minutes), long delay (14 days): to assess differences between these time points
Working Memory Test
Working memory will be assessed with the digit span task backward, a subtest of the "Wechsler Intelligenztest für Erwachsene" (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 two weeks)
Mood State (MDBF)
Mood state will be assessed 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 a parallel version for each visit.
Measured: after each treatment phase (duration two weeks)
Depressive Symptoms
Depressive symptoms will be assessed with the self-rating questionnaire MADRS-S (Cunningham 2011) (Schmidtke 1988). 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 two weeks)
Anxiety
Anxiety will be measured 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 two weeks)
Visual Analog Scales Quality of Sleep
Subjective sleep quality is assessed using a visual analogue scale (VAS) in relation to the past two weeks. 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 two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start28 Nov 2023
- Primary completion2 May 2024
- Study completion2 May 2024
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Dominique de Quervain, Prof, Study chair, University of BaselChristiane Gerhards, MD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047899
- Sponsor's protocol ID
- 2023-01628
- Other IDs
- 2023
- Acronym
- LuMus2-2023
- Status last verified
- May 2024
- First submitted
- 14 Sep 2023
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Dietary Supplement Luteolin for Two Weeks on Memory in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06047899
- Acronym / sponsor ID
- LuMus2-2023 / 2023-01628
- Conditions
- Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 21 Sep 2023 (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.
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.
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 |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: LuteolinIn 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
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 | Intervention |
| Placebomannitol formulated for oral administration (capsules) | Other | Placebo |
Primary outcome
Visual Memory Test
Time frame: short delay (5 minutes), long delay (14 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 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.
6 secondary outcomes
Verbal Memory Task
Time frame: immediate recall, short delay (10 minutes), long delay (14 days): to assess differences between these time points
Working Memory Test
Time frame: after each treatment phase (duration two weeks)
Mood State (MDBF)
Time frame: after each treatment phase (duration two weeks)
Depressive Symptoms
Time frame: after each treatment phase (duration two weeks)
Anxiety
Time frame: after each treatment phase (duration two weeks)
Visual Analog Scales Quality of Sleep
Time frame: after each treatment phase (duration two weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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, Prof study chair
University of Basel
Christiane Gerhards, 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 Prof. Dominique de Quervain, MD 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 9 May 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: short delay (5 minutes), long delay (14 days): to assess differences between these time points). 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 9 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.