Health TrialsbyHealthPanel

Lion's Mane Dosing on Attention and Mood

ConditionAttention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorNorthumbria University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Lion's Mane fruiting bodies extract

    Dietary supplement

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

  • Placebo

    Dietary supplement

    Microcrystalline cellulose

Treatment groups

24 Participants
are divided into 5 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: 50mg Lion's ManeExperimental treatment 1 intervention
Group C: 100mg Lion's ManeExperimental treatment 1 intervention
Group D: 150mg Lion's ManeExperimental treatment 1 intervention
Group E: 1.5g Lion's ManeExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northumbria University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: