The Acute and Chronic Cognitive and Cerebral Blood Flow Effects of a Sideritis Scardica (Mountain Tea) Extract: a Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Changes in cognition
研究概览
简要总结
Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of 50-70 yr olds, both acutely and following 28 days of consumption.
详细描述
The presence of polyphenols such as ferulic acid, chlorogenic acid and apigenin in Sideritis Scardica (SS or 'mountain tea') are likely responsible for the cognitive and mood effects of its consumption and this could be underpinned by the ability of such polyphenols to prevent monoamine neurotransmitter reuptake and to increase cerebral blood flow (CBF).
The current randomised, placebo controlled, parallel groups study extends on the abovementioned small amount of literature; assessing both cognitive and mood outcomes in a sample of older (50-70 yrs) adults, as well as blood pressure (BP) and CBF, in a sub-sample, utilizing near-infrared spectroscopy (NIRS). The above will be assessed acutely (pre-dose and 90- and 310-mins post dose) on day 1 and following 28 days consumption of either a placebo control, and active control of 240 mg ginkgo biloba, 475 mg SS or 950 mg SS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All treatment was prepared and randmised by a third-party researcher who had no further involvement in the study.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-70 yrs of age
- •No underlying health problem which would prevent engagement with the study
排除标准
- •BMI < 18 or > 35 kg/m2
- •High blood pressure (defined as systolic > 159 mmHg or diastolic > 90 mmHg)
- •Food allergies or insensitivities
- •Pregnancy or breast feeding
- •Currently taking any medication (use of contraceptives/hormone replacements was not excluded) or dietary supplements which would contraindicate with the study
- •Sleep disturbances and/or taking sleep aid medication
- •History of neurological, vascular or psychiatric illness
- •Current diagnosis of anxiety or depression
- •Migraines
- •Recent history (within 12 months) of alcohol/substance abuse
- •Disorder of the blood
- •Heart disorder/history of vascular illness
- •Respiratory disorder requiring regular medication
- •Type I or II diabetes
- •Renal disease, hepatic disease or severe disease of the gastrointestinal tract - Any health condition that would prevent the fulfilment of the study requirements
研究组 & 干预措施
Placebo control
Inert comparator indistinguishable from active interventions
干预措施: Placebo control (Dietary Supplement)
Low dose sideritis scardica
475 mg sideritis scardica
干预措施: Sideritis Scardica (Dietary Supplement)
High dose sideritis scardica
950 mg sideritis scardica
干预措施: Sideritis Scardica (Dietary Supplement)
Active control
240 mg ginkgo biloba
干预措施: Ginkgo biloba (Dietary Supplement)
结局指标
主要结局
Changes in cognition
时间窗: Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption
Acute and chronic change in cognitive function via the following cognitive tasks: numeric working memory, choice reaction time, corsi blocks, serial 3 and 7 subtractions, rapid visual information processing, peg and ball, name to face recall, picture recognition, word recognition, immediate word recall and delayed word recall. All tasks provide an outcome for accuracy, speed and error.
次要结局
- Cerebral Blood Flow(Pre-dose and between ~150-240-mins post-dose on day 1 and on day 28 of consumption)
- Blood Pressure(Pre-dose and 90- and 310-mins post-dose on day 1 and on day 28 of consumption)
- Changes in mood(On day 1 and following 28 days of consumption)
研究者
Emma Wightman
Principal investigator
Northumbria University