NCT07759687尚未招募不适用
Development of Optimal Acute Dosing of Lion's Mane Mushroom on Attention and Mood: A, Double-blind, Placebo- Controlled, Crossover Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Speed of Attention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo capsules (microcrystalline cellulose)
干预措施: Placebo (Dietary Supplement)
50mg Lion's Mane
Experimental
50 mg Lion's Mane fruiting body extract (20:1 ratio)
干预措施: Lion's Mane fruiting bodies extract (Dietary Supplement)
100mg Lion's Mane
Experimental
100 mg Lion's Mane fruiting body extract (20:1 ratio)
干预措施: Lion's Mane fruiting bodies extract (Dietary Supplement)
150mg Lion's Mane
Experimental
150 mg Lion's Mane fruiting body extract (20:1 ratio)
干预措施: Lion's Mane fruiting bodies extract (Dietary Supplement)
1.5g Lion's Mane
Experimental
1.5g Lion's Mane fruiting body extract (20:1 ratio)
干预措施: Lion's Mane fruiting bodies extract (Dietary Supplement)
结局指标
主要结局
Speed of Attention
时间窗: 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.
次要结局
- 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)
- Stroop(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Numeric Working Memory(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Serial Subtraction of three's(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Serial Subtraction on Seven's(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Rapid Visual Information Processing(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Positive and Negative Affect Scale (PANAS)(Baseline, 60-, 120-, 180- and 300 minutes post dose)
- Visual Analogue Mood Sales (VAMS)(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Stress Visual Analogue Scales(Baseline, 60-, 120, 180-, and 300 minutes post dose)
- Systolic Blood pressure(Baseline, 60-, 120-, 180-, and 300- minutes post dose.)
- Diastolic Blood pressure(Baseline, 60-, 120-, 180-, 300- minutes post dose)
- Heart Rate(Baseline, 60-, 120-, 180-, 300- minutes post dose)
研究者
Ellen Smith
Principal Investigator
Northumbria University
研究点 (1)
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