Brain, Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
NCT Number: NCT07759687
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lion's Mane fruiting bodies extract (20:1 ratio)
Microcrystalline cellulose
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 60-, 120-, 180-, and 300- minutes post dose.
Systolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery.
Time frame: Baseline, 60-, 120-, 180-, 300- minutes post dose
Diastolic blood pressure (mmHg) assessed following each COMPASS cognitive assessment battery.
Time frame: Baseline, 60-, 120-, 180-, 300- minutes post dose
Heart rate (BPM) assessed following each COMPASS cognitive assessment.
Contact information is provided by the study sponsor or research team.
Ellen F Smith, PhD
CONTACT
Sarah Docherty, PhD
CONTACT
Northumbria University
Other
Development of Optimal Acute Dosing of Lion's Mane Mushroom on Attention and Mood: A, Double-blind, Placebo- Controlled, Crossover Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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