Attention
Conditions
Keywords
Attention, Mood, Lion's Mane
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.
Interventions
DIETARY_SUPPLEMENTLion's Mane fruiting bodies extract
Lion's Mane fruiting bodies extract (20:1 ratio)
DIETARY_SUPPLEMENTPlacebo
Microcrystalline cellulose
Sponsors
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed of Attention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Attention | Baseline, 60-, 120-, 180- and 300 minutes post dose | 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. |
| Choice Reaction Time | Baseline, 60-, 120-, 180- and 300 minutes post dose | 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. |
| 4 Choice Reaction Time | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Digit Vigilance | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Arrow Flankers | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Stroop | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Numeric Working Memory | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Serial Subtraction of three's | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Serial Subtraction on Seven's | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Rapid Visual Information Processing | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Positive and Negative Affect Scale (PANAS) | Baseline, 60-, 120-, 180- and 300 minutes post dose | 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. |
| Visual Analogue Mood Sales (VAMS) | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Stress Visual Analogue Scales | Baseline, 60-, 120, 180-, and 300 minutes post dose | 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. |
| Systolic Blood pressure | Baseline, 60-, 120-, 180-, and 300- minutes post dose. | Systolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery. |
| Diastolic Blood pressure | Baseline, 60-, 120-, 180-, 300- minutes post dose | Diastolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery. |
| Heart Rate | Baseline, 60-, 120-, 180-, 300- minutes post dose | Heart rate (BPM) assessed following each COMPASS cognitive assessment. |
Countries
United Kingdom
Contacts
CONTACTEllen F Smith, PhD
CONTACTSarah Docherty, PhD
Outcome results
None listed