The Cognitive Effects of 'Brainwaves' Supplementation in Cognitively Intact Older Adults Experiencing Subjective Memory Decline: A Randomized, Placebo Controlled, Parallel Groups Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Cognitive function (lab-based)
研究概览
简要总结
This study investigated the effects of a proprietorial herbal supplement, Turmeric Brainwave (now Mind focus), on cognition, mood and the microbiome in older adults experiencing subjective memory decline, following 90 days supplementation.
详细描述
The primary aim of this randomised, double blind, placebo-controlled, parallel groups study was to assess the effects of a daily dose of Turmeric Brainwaves, versus placebo, both acutely and following 90 days consumption. Effects were to be assessed in 55-75 year old males and females who reported that their memory now was worse than when in their 20's. Effects were assessed via cognitive (including COMPASS and Cognimapp as well as 2 real-world long-term memory tasks (location-action (AKA Prospective Remembering Video Procedure (PRVP)) and recall of facts)) and mood (using visual analogue scales) outcomes and, additionally, stool and urine samples collected at the beginning and the end of the trial period assessed the microfloral community of the gut and urinary metabolome.
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)
盲法说明
Double blind with a placebo control. The study funder organised the formulation of both the active and placebo capsules originally in 2019 so that they were aesthetically identical. Approximately half-way through the trial, the treatments expired due to Covid-19-induced delays and the remainder of the products required to complete the trial were reconstituted by staff at Northumbria University who had no further involvement in the trial. Capsules were again matched to be aesthetically identical between active and placebo but these treatments looked different to those in the first portion of the trial.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •55-75 years at time of enrolment
- •Answers yes to the question 'would you say that your memory now is worse now than it used to be in your 20's?'
排除标准
- •Pre-existing medical condition/illnesses which would impact taking part in the study The explicit exceptions to this were controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. Other, unforeseen, exceptions were considered on a case-by-case basis; i.e. participants may have progressed to screening if they had a condition/illness which would not interact with the active treatments or impede performance.
- •Currently taking prescription medications The explicit exceptions to this were contraceptive and hormone replacement treatments for female participants where symptoms were stable and treatment would 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 have been other instances of permitted medication use where no interaction with the active treatments was anticipated.
- •High blood pressure (BP; systolic over 159 mm Hg or diastolic over 99 mm Hg)
- •Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
- •Pregnant, seeking to become pregnant or lactating
- •Learning and/or behavioural difficulties such as dyslexia or Attention Deficit Hyperactivity Disorder (ADHD)
- •Visual impairments not corrected with glasses or contact lenses (including colour-blindness)
- •Smoking (including vaping)
- •Excessive caffeine intake (>500 mg per day)
- •Clinically diagnosed food intolerances/sensitivities
- •Antibiotic, prebiotic or probiotic (including drinks; e.g. Yakult or Actimel) use within the past 8 weeks
- •Health conditions preventing fulfilment of the study requirements (this included non-diagnosed conditions for which no medication was taken)
- •Inability to complete all of the study assessments
- •Currently participating in other clinical or nutrition intervention studies, or had in the past 4 weeks (8 weeks if a probiotic study)
- •Diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- •Diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- •Suffering 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
结局指标
主要结局
Cognitive function (lab-based)
时间窗: 90 days
This outcome will be assessed via changes on the cognitive task outcomes (measured via COMPASS). COMPASS is a proprietorial software platform for delivering a range of cognitive tasks; assessing domains like memory and attention, with tasks scored for accuracy (% correct) and speed (msec).
次要结局
- Mood (General)(90 days)
- Prospective memory(90 days)
- Cognitive function (remote)(90 days)
- Mood (Anxiety)(90 days)
- Gut microbiota(90 days)
- Delayed recall(90 days)
- Urinary metabolome(90 days)
研究者
Emma Wightman
Associate Professor
Northumbria University