NCT03673930已完成不适用
The Acute and Chronic Cognitive and Cerebral Blood Flow Effects of Zanthozylum Armatum Fruit Extract: a Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Humans
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Secondary memory score
研究概览
简要总结
Zanthozylum armatum (Z. armatum)-otherwise known as Nepalese pepper, or timut-is an perennial shrub found in India and across Southeast Asia. Preparations of the bark, fruit and seeds of Z. armatum have been extensively used in traditional Indian medicine. Preliminary data have indicated that preparations of Z. armatum may also be beneficial to cognitive function. The study aims to investigate the effects acute and chronic consumption of Z. armatum on cognitive function and cerebral blood flow.
详细描述
Zanthozylum armatum (Z. armatum) is an perennial shrub found in India and across Southeast Asia. Preparations of the bark, fruit and seeds of Z. armatum have been extensively used in traditional Indian medicine. For example, the fruits and seeds have been employed as an aromatic tonic in fever and dyspepsia and the essential oil of the fruits has exhibited antibacterial, antifungal and anthelmintic properties. Furthermore, the dried fruits are used as spice, especially in Nepalese and Sichuan cuisine with increasing popularity across Europe. With regard to physiological effects relevant to brain function, Z. armatum has also been traditionally used as a cardio-depressant; these vasodilatory properties have recently being linked to its antagonistic effect on calcium ion channel function as demonstrated in isolated rabbit aorta tissue. In addition, the observed anti-inflammatory and antioxidant effects of preparations of Z. armatum may serve to beneficially impact cognition with chronic administration.
Although direct effects of Z. armatum on brain function have yet to be assessed; Zanthozylum fruit comprises one constituent of the traditional Japanese herbal medicine Daikenchuto (DKT) where some data do exist. In a series of trials investigating the effects of DKT on learning and memory function in mice, it was established that the extract of Zanthozylum fruit contained in DKT alone that was associated with reductions in escape latency in the Morris Water Maze task. Interestingly, the authors also revealed that it was the amide hydroxy-ɑ-sanshool (HAS) isolated from the Zanthozylum fruit extract that was associated with these effects, speculating that the effect of HAS on escape latencies was due to a facilitation effect of HAS on acetylcholine release.
Given the evidence of potentially relevant mechanisms of action and initial evidence of cognitive effects of HAS in murine models, the aim of this study is to assess the acute and chronic effects of Z. armatum on cognitive function, mood, and cerebral blood flow in healthy adults aged 30 to 55 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 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
- •Aged 30 to 55 years at the time of giving consent
- •Are proficient in English equivalent to IELTS band 6 or above
排除标准
- •Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) hypertension, arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. 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
- •Are currently taking prescription medications or dietary supplements including omega fatty acids / fish oils NOTE: the explicit exceptions to this are hormone replacement treatments for female participants where symptoms are stable, those medications used in the treatment of arthritis, high blood pressure, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening
- •Have planned a surgery requiring general anaesthesia
- •Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- •Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2
- •Are pregnant, seeking to become pregnant or lactating
- •Have learning difficulties, dyslexia
- •Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- •Smoker or regular consumption of nicotine containing products e.g. patches, gum, vaping
- •Have a history of alcohol or drug abuse
- •Excessive caffeine intake (>500 mg per day)
- •Have food intolerances/sensitivities, especially against citrus fruits
- •Have any health condition that would prevent fulfilment of the study requirements
- •Are unable to complete all of the study assessments
- •Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- •Do not have a bank account (required for payment)
- •Are non-compliant with regards treatment consumption
研究组 & 干预措施
Zanthozylum armatum
Active Comparator
fruit extract
干预措施: Zanthozylum armatum (Dietary Supplement)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Secondary memory score
时间窗: Chronic (57 days)
This is a composite measure derived from summing the z score performance on the following cognitive tasks: immediate word recall, delayed word recall, delayed picture recognition, delayed word recognition, delayed name to face recall (-1 to 1 where higher is better).
次要结局
- Numeric working memory accuracy(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Numeric working memory reaction time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Rapid visual information processing false alarms(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Mental fatigue(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Subjective mood - Alert(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Subjective mood - Content (visual analogue scale)(Acute (45, 180, 300 minutes post-dose))
- Cerebral blood flow during performance of cognitive tasks(Superimposed chronic (57 days plus 120, 150 minutes post-dose))
- Subjective mood - Content(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Subjective mood - Calm (Bond Lader visual analogue scale)(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- STAI-state total score(Chronic (57 days))
- STAI-trait total score(Baseline)
- Working memory score(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Secondary memory score(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Speed of memory score(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Accuracy of attention score(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Choice reaction time accuracy(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Speed of attention score(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Immediate word recall task correctly identified words(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Picture recognition reaction time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Peg and ball task planning time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Peg and ball task completion time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Serial 7 subtractions total error responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Cerebral blood flow at rest(Superimposed chronic (57 days plus 120, 150 minutes post-dose))
- Immediate word recall task error responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Delayed word recall task correctly identified words(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Delayed word recall task correctly error responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Picture recognition accuracy(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Word recognition accuracy(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Word recognition reaction time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Name to face recall correct responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Name to face recall reaction time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Choice reaction time reaction time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Rapid visual information processing accuracy(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Rapid visual information processing reaction time(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Subjective mood - Calm(Chronic (57 days))
- Peg and ball task errors(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Corsi blocks accuracy(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Serial 3 subtractions total responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Serial 3 subtractions total error responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Serial 7 subtractions total responses(Superimposed chronic (57 days plus 45, 180, 300 minutes post-dose))
- Secondary memory score(Acute (45, 180, 300 minutes post-dose))
- Working memory score(Chronic (57 days))
- Working memory score(Acute (45, 180, 300 minutes post-dose))
- Delayed word recall task correctly identified words(Acute (45, 180, 300 minutes post-dose))
- Speed of memory score(Acute (45, 180, 300 minutes post-dose))
- Speed of memory score(Chronic (57 days))
- Accuracy of attention score(Acute (45, 180, 300 minutes post-dose))
- Accuracy of attention score(Chronic (57 days))
- Speed of attention score(Acute (45, 180, 300 minutes post-dose))
- Speed of attention score(Chronic (57 days))
- Immediate word recall task correctly identified words(Acute (45, 180, 300 minutes post-dose))
- Immediate word recall task correctly identified words(Chronic (57 days))
- Immediate word recall task error responses(Acute (45, 180, 300 minutes post-dose))
- Immediate word recall task error responses(Chronic (57 days))
- Delayed word recall task correctly identified words(Chronic (57 days))
- Delayed word recall task correctly error responses(Acute (45, 180, 300 minutes post-dose))
- Delayed word recall task correctly error responses(Chronic (57 days))
- Picture recognition accuracy(Acute (45, 180, 300 minutes post-dose))
- Picture recognition accuracy(Chronic (57 days))
- Picture recognition reaction time(Acute (45, 180, 300 minutes post-dose))
- Picture recognition reaction time(Chronic (57 days))
- Word recognition accuracy(Acute (45, 180, 300 minutes post-dose))
- Word recognition accuracy(Chronic (57 days))
- Word recognition reaction time(Acute (45, 180, 300 minutes post-dose))
- Word recognition reaction time(Chronic (57 days))
- Name to face recall correct responses(Acute (45, 180, 300 minutes post-dose))
- Name to face recall correct responses(Chronic (57 days))
- Name to face recall reaction time(Acute (45, 180, 300 minutes post-dose))
- Name to face recall reaction time(Chronic (57 days))
- Peg and ball task planning time(Acute (45, 180, 300 minutes post-dose))
- Peg and ball task planning time(Chronic (57 days))
- Peg and ball task completion time(Acute (45, 180, 300 minutes post-dose))
- Peg and ball task completion time(Chronic (57 days))
- Peg and ball task errors(Acute (45, 180, 300 minutes post-dose))
- Peg and ball task errors(Chronic (57 days))
- Corsi blocks accuracy(Acute (45, 180, 300 minutes post-dose))
- Corsi blocks accuracy(Chronic (57 days))
- Choice reaction time accuracy(Acute (45, 180, 300 minutes post-dose))
- Choice reaction time accuracy(Chronic (57 days))
- Choice reaction time reaction time(Acute (45, 180, 300 minutes post-dose))
- Choice reaction time reaction time(Chronic (57 days))
- Numeric working memory accuracy(Acute (45, 180, 300 minutes post-dose))
- Numeric working memory accuracy(Chronic (57 days))
- Numeric working memory reaction time(Acute (45, 180, 300 minutes post-dose))
- Numeric working memory reaction time(Chronic (57 days))
- Serial 3 subtractions total responses(Acute (45, 180, 300 minutes post-dose))
- Serial 3 subtractions total responses(Chronic (57 days))
- Serial 3 subtractions total error responses(Acute (45, 180, 300 minutes post-dose))
- Serial 3 subtractions total error responses(Chronic (57 days))
- Serial 7 subtractions total responses(Acute (45, 180, 300 minutes post-dose))
- Serial 7 subtractions total responses(Chronic (57 days))
- Serial 7 subtractions total error responses(Acute (45, 180, 300 minutes post-dose))
- Serial 7 subtractions total error responses(Chronic (57 days))
- Rapid visual information processing accuracy(Acute (45, 180, 300 minutes post-dose))
- Rapid visual information processing accuracy(Chronic (57 days))
- Rapid visual information processing reaction time(Acute (45, 180, 300 minutes post-dose))
- Rapid visual information processing reaction time(Chronic (57 days))
- Rapid visual information processing false alarms(Acute (45, 180, 300 minutes post-dose))
- Rapid visual information processing false alarms(Chronic (57 days))
- Mental fatigue(Acute (45, 180, 300 minutes post-dose))
- Mental fatigue(Chronic (57 days))
- Subjective mood - Alert(Acute (45, 180, 300 minutes post-dose))
- Subjective mood - Alert(Chronic (57 days))
- Subjective mood - Content(Chronic (57 days))
- Subjective mood - Calm(Acute (45, 180, 300 minutes post-dose))
- Cerebral blood flow during performance of cognitive tasks(Acute (120, 150 minutes post-dose))
- Cerebral blood flow at rest(Acute (120, 150 minutes post-dose))
- Cerebral blood flow at rest(Chronic (57 days))
研究者
研究点 (1)
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