Lion's Mane Dosing on Attention and Mood

NCT07759687 | Not Yet Recruiting

• 1 other identifier: 13CG4
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Attention

Keywords

Attention; Mood; Lion's Mane

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 60-, 120-, 180- and 300 minutes post dose

Secondary Outcomes (16)

• Accuracy of Attention

  Baseline, 60-, 120-, 180- and 300 minutes post dose

• Choice Reaction Time

  Baseline, 60-, 120-, 180- and 300 minutes post dose

• 4 Choice Reaction Time

  Baseline, 60-, 120, 180-, and 300 minutes post dose

• Digit Vigilance

  Baseline, 60-, 120, 180-, and 300 minutes post dose

• Arrow Flankers

  Baseline, 60-, 120, 180-, and 300 minutes post dose

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo capsules (microcrystalline cellulose)

Dietary Supplement: Placebo

50mg Lion's Mane

EXPERIMENTAL

50 mg Lion's Mane fruiting body extract (20:1 ratio)

Dietary Supplement: Lion's Mane fruiting bodies extract

100mg Lion's Mane

EXPERIMENTAL

100 mg Lion's Mane fruiting body extract (20:1 ratio)

Dietary Supplement: Lion's Mane fruiting bodies extract

150mg Lion's Mane

EXPERIMENTAL

150 mg Lion's Mane fruiting body extract (20:1 ratio)

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)

Dietary Supplement: Lion's Mane fruiting bodies extract

Interventions

Lion's Mane fruiting bodies extract DIETARY_SUPPLEMENT

Lion's Mane fruiting bodies extract (20:1 ratio)

1.5g Lion's Mane; 100mg Lion's Mane; 150mg Lion's Mane; 50mg Lion's Mane

Placebo DIETARY_SUPPLEMENT

Microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Brain, Performance and Nutrition Research Centre

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

Central Study Contacts

Ellen F Smith, PhD

CONTACT

+44 191 243 7252; ellen.f.smith@northumbria.ac.uk

Sarah Docherty, PhD

CONTACT

sarah4.docherty@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)