AttentionNCT07759687
Lion's Mane Dosing on Attention and Mood
A study testing Lion's Mane fruiting bodies extract in people with Attention, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The primary purpose of the research is to evaluate in healthy adults the time course effects of varying dosages of Lion's mane mushroom on attention and mood. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention
- What is being tested?
- Lion's Mane fruiting bodies extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health
- Participants must be aged 18 to 45 at the time of giving consent
- Understand and are willing to participate in all scheduled visits and to adhere to the trial procedures outlined in the subject information sheet
- Are fluent in English (equivalent to IELTS Level 6)
Who cannot join
- Have any pre-existing medical condition/illness which will impact taking part in the study. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis, i.e., participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance so it's worth discussing any medical conditions with the researcher prior to booking lab appointments. NOTE: the explicit exceptions to this is controlled hayfever, asthma, hypo/hyperthyroidism, high blood pressure, high cholesterol, reflux.
- Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
- Have a history of experiencing difficulty swallowing tablets including in capsule form
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2 (unless waist to hip ratio is less than or equal to 0.85 (female) or 0.90 (male))
- Engage in the extreme dietary habit of intermittent fasting, as judged by the Investigator
Show all 25Show fewer
- Are pregnant, seeking to become pregnant or lactating
- Have been diagnosed with a neurological condition, or assessed as having a learning/behavioural or neurodevelopmental difference such as dyslexia, autism, or ADHD
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Use illegal/recreational drugs
- Have relevant food allergies/intolerances/ sensitivities
- Consume over 500mg of caffeine per day
- Have taken dietary supplements e.g., Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taken are out of choice and not medically prescribed or advised). NOTE - Vitamin D and iron supplements are allowed for this trial if they have been advised by GP to increase levels to a normal range and have been taken for at least 4 weeks consistently and will be taken consistently throughout the trial.
- Are currently participating in any other chronic clinical or nutrition intervention studies, or have done so in the past 4 weeks
- Have taken antibiotics within the past 4 weeks
- Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months (including medically diagnosed anxiety, depression or stress-related disorders).
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medications may be taken)
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Not be a native speaker of English or at least fluent in English
- Smoke tobacco or vape nicotine or use nicotine replacement products
- Have worked night shift the night prior to attending the laboratory
- Are unable to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
- Have any known active infections
- Do not have a bank account (required for payment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Docherty, PhD contact
United Kingdom1 site
Brain, Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
Ellen F Smith, PhD, +44 191 243 7252, ellen.f.smith@northumbria.ac.uk
About this study
Official title: Development of Optimal Acute Dosing of Lion's Mane Mushroom on Attention and Mood: A, Double-blind, Placebo- Controlled, Crossover Study
The primary purpose of the research is to evaluate in healthy adults the time course effects of varying dosages of Lion's mane mushroom on attention and mood.
- Conditions
- Attention
- Being tested
- Lion's Mane fruiting bodies extract, Placebo
- Keywords
- Attention, Mood, Lion's Mane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lion's Mane fruiting bodies extractDietary supplement
Lion's Mane fruiting bodies extract (20:1 ratio)
PlaceboDietary supplement
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules (microcrystalline cellulose) Receives: Dietary Supplement: Placebo |
| 50mg Lion's Mane | Experimental | 50 mg Lion's Mane fruiting body extract (20:1 ratio) Receives: Dietary Supplement: Lion's Mane fruiting bodies extract |
| 100mg Lion's Mane | Experimental | 100 mg Lion's Mane fruiting body extract (20:1 ratio) Receives: Dietary Supplement: Lion's Mane fruiting bodies extract |
| 150mg Lion's Mane | Experimental | 150 mg Lion's Mane fruiting body extract (20:1 ratio) Receives: Dietary Supplement: Lion's Mane fruiting bodies extract |
| 1.5g Lion's Mane | Experimental | 1.5g Lion's Mane fruiting body extract (20:1 ratio) Receives: Dietary Supplement: Lion's Mane fruiting bodies extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed of Attention
Speed of Attention cognitive domain, calculated from reaction time (msec) performance on the following tasks: Choice Reaction Time, 4 Choice Reaction Time, Digit Vigilance, Arrow Flankers, Stroop, Rapid Visual Information Processing.
Measured: Baseline, 60-, 120-, 180- and 300 minutes post dose
Secondary outcomes (16)
Accuracy of Attention
Accuracy of Attention cognitive domain, calculated from accuracy of performance (%) on the following tasks: Choice Reaction Time, 4 Choice Reaction Time, Digit Vigilance, Arrow Flankers, Stroop, Rapid Visual Information Processing.
Measured: Baseline, 60-, 120-, 180- and 300 minutes post dose
Choice Reaction Time
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Measuring attention and vigilance.
Choice Reaction Time (% accuracy, reaction time (msec)). With higher accuracy and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120-, 180- and 300 minutes post dose
4 Choice Reaction Time
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task assesses attention and vigilance.
4 Choice Reaction Time (% accuracy, reaction time (msec)). With higher accuracy and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Digit Vigilance
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task assesses attention and vigilance.
Digit Vigilance (% accuracy, reaction time (msec), false alarms). With higher accuracy, lower false alarms and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Arrow Flankers
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task assesses attention and vigilance.
Arrow Flankers (% accuracy, reaction time (msec). With higher accuracy and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Stroop
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task assesses attention, vigilance and executive function.
Stroop Task (% accuracy, reaction time (msec)). With higher accuracy and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Numeric Working Memory
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task measures working memory.
Numeric Working Memory (% accuracy, reaction time (msec)). With higher accuracy and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Serial Subtraction of three's
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task measures working memory and cognitive demand.
Serial subtraction of three's (number of correct responses, number of error responses). With more correct responses and less error responses indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Serial Subtraction on Seven's
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task assesses working memory and cognitive demand.
Serial subtraction of seven's (number correct responses, number error responses). With more correct responses and less errors indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Rapid Visual Information Processing
Administered by the cognitive battery Computerised Mental Performance Assessment System (COMPASS). Task assesses attention, vigilance and cognitive demand.
Rapid Visual Information Processing (% accuracy, reaction time (msec), false alarms). With higher accuracy, lower false alarms and quicker reaction time indicating better performance.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Positive and Negative Affect Scale (PANAS)
Positive and Negative Affect Scale (Watson, Clark and Tellegan, 1988).
Includes 20 single-word emotion items (10 for positive affect, 10 for negative affect). Participants rate each word on a 5-point scale from 1 ("not at all") to 5 ("extremely"). It produces a Positive Affect score, and a Negative Affect score.
Positive Affect score: sum of 10 positive items. Higher scores indicate higher joyful engagement.
Negative Affect score: sum of the 10 negative items. Higher scores indicate higher general distress and unpleasurable moods.
Scores for each sub scale range from 10 to 50.
Measured: Baseline, 60-, 120-, 180- and 300 minutes post dose
Visual Analogue Mood Sales (VAMS)
Mood assessment administered using COMPASS computerised battery. Comprises of 18 x 100% lines anchored at either end by antonyms (e.g. "alert-drowsy", "calm-excited"). Participants indicate their current subjective position between the antonyms on the line. Scores are collapsed into three measures derived by factor analysis; Alertness, Stress, Tranquillity.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Stress Visual Analogue Scales
A mood outcome assessed as part of the COMPASS battery. Four visual analogue scales on 100% lines anchored by "Not at all" on one end and "Extremely" on the other.
These include the following questions: "how stressed do you feel?", "how anxious do you feel?", "how relaxed do you feel?", and "how calm do you feel?".
Data from the scales is then combined to create an average stress score, with the positive items "calm" and "relaxed" reversed. Higher scores indicate higher stress.
Measured: Baseline, 60-, 120, 180-, and 300 minutes post dose
Systolic Blood pressure
Systolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery.
Measured: Baseline, 60-, 120-, 180-, and 300- minutes post dose.
Diastolic Blood pressure
Diastolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery.
Measured: Baseline, 60-, 120-, 180-, 300- minutes post dose
Heart Rate
Heart rate (BPM) assessed following each COMPASS cognitive assessment.
Measured: Baseline, 60-, 120-, 180-, 300- minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Smith, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759687
- Sponsor's protocol ID
- 13CG4
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Optimal Acute Dosing of Lion's Mane Mushroom on Attention and Mood: A, Double-blind, Placebo- Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT07759687
- Acronym / sponsor ID
- 13CG4
- Conditions
- Attention
- Keywords
- Attention, Mood, Lion's Mane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (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 primary purpose of the research is to evaluate in healthy adults the time course effects of varying dosages of Lion's mane mushroom on attention and mood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules (microcrystalline cellulose) |
| 50mg Lion's Mane | Experimental | Dietary Supplement: Lion's Mane fruiting bodies extract50 mg Lion's Mane fruiting body extract (20:1 ratio) |
| 100mg Lion's Mane | Experimental | Dietary Supplement: Lion's Mane fruiting bodies extract100 mg Lion's Mane fruiting body extract (20:1 ratio) |
| 150mg Lion's Mane | Experimental | Dietary Supplement: Lion's Mane fruiting bodies extract150 mg Lion's Mane fruiting body extract (20:1 ratio) |
| 1.5g Lion's Mane | Experimental | Dietary Supplement: Lion's Mane fruiting bodies extract1.5g Lion's Mane fruiting body extract (20:1 ratio) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must self-assess themselves as being in good health
- Participants must be aged 18 to 45 at the time of giving consent
- Understand and are willing to participate in all scheduled visits and to adhere to the trial procedures outlined in the subject information sheet
- Are fluent in English (equivalent to IELTS Level 6)
Key exclusion criteria (25 listed)
- Have any pre-existing medical condition/illness which will impact taking part in the study. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis, i.e., participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance so it's worth discussing any medical conditions with the researcher prior to booking lab appointments. NOTE: the explicit exceptions to this is controlled hayfever, asthma, hypo/hyperthyroidism, high blood pressure, high cholesterol, reflux.
- Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
- Have a history of experiencing difficulty swallowing tablets including in capsule form
- Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2 (unless waist to hip ratio is less than or equal to 0.85 (female) or 0.90 (male))
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 |
|---|---|---|
| Lion's Mane fruiting bodies extractLion's Mane fruiting bodies extract (20:1 ratio) | Dietary supplement | 1.5g Lion's Mane, 100mg Lion's Mane, 150mg Lion's Mane, 50mg Lion's Mane |
| PlaceboMicrocrystalline cellulose | Dietary supplement | Placebo |
Primary outcome
Speed of Attention
Time frame: Baseline, 60-, 120-, 180- and 300 minutes post dose
Speed of Attention cognitive domain, calculated from reaction time (msec) performance on the following tasks: Choice Reaction Time, 4 Choice Reaction Time, Digit Vigilance, Arrow Flankers, Stroop, Rapid Visual Information Processing.
16 secondary outcomes
Accuracy of Attention
Time frame: Baseline, 60-, 120-, 180- and 300 minutes post dose
Choice Reaction Time
Time frame: Baseline, 60-, 120-, 180- and 300 minutes post dose
4 Choice Reaction Time
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Digit Vigilance
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Arrow Flankers
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Stroop
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Numeric Working Memory
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Serial Subtraction of three's
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Serial Subtraction on Seven's
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Rapid Visual Information Processing
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, 60-, 120-, 180- and 300 minutes post dose
Visual Analogue Mood Sales (VAMS)
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Stress Visual Analogue Scales
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Systolic Blood pressure
Time frame: Baseline, 60-, 120-, 180-, and 300- minutes post dose.
Diastolic Blood pressure
Time frame: Baseline, 60-, 120-, 180-, 300- minutes post dose
Heart Rate
Time frame: Baseline, 60-, 120-, 180-, 300- minutes post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Sarah Docherty, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lion's Mane fruiting bodies extract in people with Attention, run by Northumbria University at 1 site in United Kingdom.
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 4 inclusion and 25 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen F Smith, PhD (+44 191 243 7252, ellen.f.smith@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed of Attention (time frame: Baseline, 60-, 120-, 180- and 300 minutes post dose). 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 12 Aug 2026.