Cognitive Effects of Sage in Healthy Humans
赞助:
Northumbria University
合作者:
信息的提供 (责任方):
Emma Wightman，Northumbria University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 20, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | September 3, 2018 | ||
| 预计主要完成日期 | April 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Acute change in global cognitive task performance[ Time Frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation ] Changes in executive function, working memory, spatial memory, secondary memory and attention as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains. Acute changes in mood; as assessed by the Bond-Lader mood scales[ Time Frame: 120 minutes and 240 minutes post dose on day 1 of treatment supplementation ] The Bond-Lader mood visual analogue scales will be used at baseline and 120- and 240-minutes post dose on day 1. The derived scores on alertness, calmness and contentedness will be 'changed-from-baseline' and this score compared across the treatments. Interim changes in global cognitive task performance[ Time Frame: Day 7, day 14, day 21 and day 28 ] Changes in attention, executive function, working memory and episodic memory as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains. Chronic changes in cognitive task performance[ Time Frame: Pre-dose, 120 minutes and 240 minutes post-dose on day 29 of treatment supplementation ] Changes in executive function, working memory, spatial memory, secondary memory and attention as compared to pre-treatment performance on day 1. All tasks have the same x3 outcome measures; accuracy (% correct), errors (% incorrect) and speed (milliseconds) and the individual task scores will therefore be collapsed into global cognitive domains. Chronic changes in mood; as assessed by the Bond-Lader mood scales[ Time Frame: Pre-dose, 120 minutes and 240 minutes post dose on day 29 of treatment supplementation ] The Bond-Lader mood visual analogue scales will be used at baseline and 120- and 240-minutes post dose on day 29. The derived scores on alertness, calmness and contentedness will be 'changed-from-baseline' and this score compared across the treatments. Change in prospective memory performance; as assessed by a prospective memory task (the prospective remembering video task)[ Time Frame: Day 25 and day 29 ] This individual task is called the Prospective Remembering Video Task (PRVP) and requires participants to remember a list of remembered locations and actions and identify these as they watch a video with them unfolding. The task is scored for difference in prospective memory/location learning performance between active and placebo on day 25 of supplementation period and also the difference in amount of memory decay of prospective memory/location learning on day 29 of treatment supplementation. Acute changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI)[ Time Frame: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation ] The STAI will be used at baseline and 120- and 240-minutes post dose on day 1. The anxiety scores will be 'changed-from-baseline' and this score compared across the treatments. Chronic changes in mood; as assessed by the 'state, trait anxiety inventory' (STAI)[ Time Frame: 120 minutes and 240 minutes post dose on day 29 of treatment supplementation ] The STAI will be used at baseline and 120- and 240-minutes post dose on day 29. The anxiety scores will be 'changed-from-baseline' and this score compared across the treatments. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Cognitive Effects of Sage in Healthy Humans | ||
| 正式标题 ICMJE | The Acute and Chronic Cognitive Effects of a Sage Extract: a Randomized, Placebo Controlled Study in Healthy Humans | ||
| 简要概况 | Extracts of sage and polyphenols have separately been reported to interact with central nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has combined these interventions. The current study investigates the effects of this combined intervention in N=90 healthy males and females between 30-60 yrs, at 600 mg versus placebo, on cognition and mood over a 29 day period. |
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| 详细说明 | Improved cognitive performance has been observed in humans following supplementation of sage extracts; including recall and mental arithmetic ability. Aspects of mood have also shown improvements; e.g. increased alertness, calmness and contentedness and reduced mental fatigue. These effects are believed to be underpinned by interactions with cholinergic and GABA pathways. Polyphenols too have shown promise in boosting cognition and mood and interaction with vasodilatory pathways and GABA neurotransmission are purported to be the likely mechanisms involved. Research has yet to investigate if a combination of sage terpenes and polyphenols could be even more efficacious via synergistic interaction.The current study investigates the effects of a 600 mg sage/polyphenol combination on cognition and mood in N=90 healthy male and female participants between the ages of 30-60 yrs acutely; on day 1 of supplementation, and chronically; after 29 days. Cognitive and mood data will also be collected every 7 days in the interim via a mobile phone cognitive task battery. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: The study will follow a randomised, double-blind, placebo-controlled, parallel groups design. 盲法: Interventional 盲法描述:Double blind. Randomized by a disinterested third party. Placebo and active capsules matched for aesthetics. 主要目的: Other |
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| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
90 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | April 1, 2019 | ||
| 预计主要完成日期 | April 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Participants must self-assess themselves as being in good health. - Aged 30 to 60 years at the time of giving consent - In daytime employment and/or higher education Exclusion Criteria: - Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) 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 NOTE: the explicit exceptions to this are contraceptive and hormone replacement treatments for female participants where symptoms are stable and treatment will not change during the course of the study, those medications used in the treatment of arthritis, 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 high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg) - Have a Body Mass Index (BMI) outside of the range 18.5-30 kg/m2 - Are pregnant, seeking to become pregnant or lactating - Have learning and/or behavioural difficulties such as dyslexia or ADHD - Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness) - Smoker - excessive caffeine intake (>500 mg per day) - Have food intolerances/ sensitivities - Have taken antibiotics, prebiotics or probiotics (including drinks. Eg. Yakult or Actimel) within the past 8 weeks - Have any health condition that would prevent fulfillment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken) - 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 - 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 - Suffers from frequent migraines that require medication (more than or equal to 1 per month) - Sleep disturbances (including night-shift work) and/ or are taking sleep aid medication - Any known active infections - Does not have a bank account (required for payment) - Are non-compliant with regards treatment consumption (see 4.3) | ||
| 性别 |
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| 年龄 | 最小年龄：30 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United Kingdom | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Emma Wightman，Northumbria University | ||
| 研究赞助商 ICMJE | Northumbria University | ||
| 合作者 ICMJE | |||
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| PRS 账户 | Northumbria University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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