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临床试验/NCT02996578
NCT02996578已完成不适用

Consumption of Polyphenol Rich Cocoa Products Over 8 Weeks and Its Effect on Cognitive Function in Individuals in Their 5th Decade of Life.

Queen Margaret University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年4月17日最近更新:
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
16
试验地点
1
主要终点
Cognitive Function

研究概览

简要总结

This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.

详细描述

Healthy cognitive ageing is an important aspect of the ageing process as it involves larger numbers of people compared to those who have already been diagnosed with conditions on the dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle factor modification interventions to help maintain cognitive well-being are warranted.

With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role in successful ageing by helping to delay the onset of age-related conditions (Hendrickx, McEwen & van der Ouderaa, 2005; Brown, Riby & Reay, 2009; Monti, Moulton & Cohen, 2015). Studies have investigated the potential role of polyphenols as part of a neuroprotective lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al., 2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.

Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu & Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against cellular alteration by modulating the neuronal function against endogenous neurotoxins and inhibition of glial induced neuroinflammation (Vauzour, 2012).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Males & Females aged 50-60years of age with normal or corrected to normal vision
  • •BMI cut off points of ≥18.5 to ≤29.9 kg/m2
  • •Waist circumference smaller than 102cm for males & smaller than 88cm for women
  • •Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
  • •MoCA test score ≥ 26

排除标准

  • •Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
  • •Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
  • •Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
  • •No previous history of stroke, brain trauma and other head-related injuries
  • •No diagnosis of depression and/or anxiety
  • •No previous cancer diagnosis
  • •Taking antibiotics
  • •Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS)
  • •Women on Hormone Replacement Therapy (HRT)
  • •Taking medication that can cause drowsiness or affect cognitive functioning
  • •Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract
  • •Taking soy/a supplements
  • •History of alcohol misuse
  • •Fear of needles and/or fainting when blood is taken

研究组 & 干预措施

Solid Matrix - Intervention

Active Comparator

Dietary Supplement: polyphenol rich chocolate bar

17.5g of commercially available dark chocolate will be consumed daily for 8 weeks

干预措施: polyphenol rich chocolate bar (Dietary Supplement)

Powder Matrix - Intervention

Active Comparator

Dietary Supplement: polyphenol rich cocoa powder

6g of commercially available cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks

干预措施: polyphenol rich cocoa powder (Dietary Supplement)

Solid Matrix Intervention - Placebo

Placebo Comparator

Dietary Supplement: low polyphenol chocolate

17.5g of commercially available, nutritionally similar, dark chocolate will be consumed daily for 8 weeks

干预措施: low polyphenol content chocolate bar (Dietary Supplement)

Powder Matrix - Placebo

Placebo Comparator

Dietary Supplement: nutritionally similar low polyphenol cocoa powder

6g of commercially available, nutritionally similar, cocoa powder (provided as 6 x 1g gelatine capsules) will be consumed daily for 8 weeks

干预措施: low polyphenol content cocoa powder (Dietary Supplement)

结局指标

主要结局

Cognitive Function

时间窗: 8 weeks

A test battery consisting of 7 tests will be used to investigate the role of cocoa flavanols on cognitive function in the cohort.

次要结局

  • Blood Pressure(8 weeks)
  • Height (m)(8 weeks)
  • Pulse Wave Analysis(8 weeks)
  • Weight (Kg)(8 weeks)
  • Body Fat Percentage(8 weeks)
  • Energy intakes (Kj)(8 weeks)
  • Glycated Haemoglobin (HbA1c)(8 weeks)
  • Flavonoid intakes (mg)(8 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruth Ashaye

Principal Investigator

Queen Margaret University

研究点 (1)

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