Not yet recruitingNCT07759687Updated Aug 12, 2026

Lion's Mane Dosing on Attention and Mood

An interventional study of Lion's Mane fruiting bodies extract and Placebo in Attention, sponsored by Northumbria University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Northumbria University · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Conditions studied

Attention

Keywords

Attention
Mood
Lion's Mane

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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
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)

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 24 participants (estimated)

Study arms

Placebo comparator
Placebo
Placebo capsules (microcrystalline cellulose)
Dietary Supplement: Placebo
Experimental
50mg Lion's Mane
50 mg Lion's Mane fruiting body extract (20:1 ratio)
Dietary Supplement: Lion's Mane fruiting bodies extract
Experimental
100mg Lion's Mane
100 mg Lion's Mane fruiting body extract (20:1 ratio)
Dietary Supplement: Lion's Mane fruiting bodies extract
Experimental
150mg Lion's Mane
150 mg Lion's Mane fruiting body extract (20:1 ratio)
Dietary Supplement: Lion's Mane fruiting bodies extract
Experimental
1.5g Lion's Mane
1.5g Lion's Mane fruiting body extract (20:1 ratio)
Dietary Supplement: Lion's Mane fruiting bodies extract

Interventions

Dietary supplementLion's Mane fruiting bodies extract
Lion's Mane fruiting bodies extract (20:1 ratio)
Dietary supplementPlacebo
Microcrystalline cellulose

What researchers measure

Primary outcomes

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.
Time frame: Baseline, 60-, 120-, 180- and 300 minutes post dose

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 60-, 120, 180-, and 300 minutes post dose
Systolic Blood pressure
Systolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery.
Time frame: Baseline, 60-, 120-, 180-, and 300- minutes post dose.
Diastolic Blood pressure
Diastolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery.
Time frame: Baseline, 60-, 120-, 180-, 300- minutes post dose
Heart Rate
Heart rate (BPM) assessed following each COMPASS cognitive assessment.
Time frame: Baseline, 60-, 120-, 180-, 300- minutes post dose

Study locations

1 site

Brain, Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear NE1 8ST, United Kingdom
- Ellen F Smith, PhD · Contact · ellen.f.smith@northumbria.ac.uk · +44 191 243 7252

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07759687
Lead sponsor: Northumbria University
Responsible party: Ellen Smith (Principal Investigator, Northumbria University) — Principal investigator
First posted: Aug 12, 2026
Start date: Aug 2026 (estimated)
Primary completion: Nov 2026 (estimated)
Completion: Nov 2026 (estimated)
Last update: Aug 12, 2026

Study contacts

Ellen F Smith, PhD

Contact

ellen.f.smith@northumbria.ac.uk

+44 191 243 7252

Sarah Docherty, PhD

Contact

sarah4.docherty@northumbria.ac.uk

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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