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临床试验/NCT03350100
NCT03350100已完成不适用

An Investigation Into the Acute Effects of Date Fruit (Phoenix Dactylifera L.) on Mood and Cognitive Performance in Healthy Volunteers.

Newcastle University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年10月31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
36
试验地点
1
主要终点
Cognition: Digit Vigilance

研究概览

简要总结

A number of studies have considered the neuroprotective effects of date fruit on neurodegenerative diseases in animals. However, so far no study has addressed the acute effects of date fruit on mood and cognitive performance in humans. This study will investigate the acute effects of two different cultivars of Saudi dates on mood and cognitive performance into healthy volunteers.

This study will follow a double blind, randomised, placebo controlled, repeated measures, cross over design with two active treatment arms versus placebo. Treatment orders will be counterbalanced with the use of a Latin Square design.

Thirty six healthy participants aged between 18 and 35 will be recruited. Participants will be required to undergo a screening/training visit, followed by three measurement visits at weekly intervals. The trial will last for 3 months in total.

详细描述

Introduction Fruit of the date palm (P. dactylifera) may be considered an emerging and potential candidate for the development of health-promoting foods owing to its high nutritive values (Juhaimi, Ghafoor et al. 2012). Recently, scientific studies have revealed the medicinal properties of P. dactylifera in the different ripening stages by examining anti-inflammatory, anti-angiogenic and antibacterial activity. The anti-inflammatory activity of various parts of P. dactylifera have been evaluated (Shabani, Zangiabadi et al. 2013); it is evident from these studies that, both in vivo and in vitro, date fruits display anti-inflammatory activity, strongly linked to secondary metabolites and antioxidant behaviour.

More than 16 published studies have investigated the physiological and the psychological effects of P. dactylifera on the brain using animal models. Although this domain of research is in its infancy , the findings are quite promising and suggest that date fruits have the potential to become, on the one hand, a neuroprotective agent in ischemic stroke (Majid, Marzieh et al. 2008), brain damage (Kalantaripour, Asadi-Shekaari et al. 2012), and Alzheimer's disease and (Essa, Akbar et al. 2016), on the other hand, a brain enhancer by attenuating impairment in cognition caused by neurodegenerative diseases (Subash, Essa et al. 2015).

Aim The aim of this study is to investigate the acute effects of two different cultivars of P. dactylifera commonly consumed in Saudi Arabia on mood and cognitive performance of healthy volunteers.

Design The project will investigate the acute effects on human cognitive function and mood after the administration of a single dose of two different date fruits using a yogurt as the carrier medium against a control yoghurt matched for sugar, flavour, volume, fibers, taste and appearance. The study will follow a double-blind, counterbalanced, placebo controlled, repeated measures design, with two active treatment arms versus placebo, with one week between each measurement visit. Treatment orders will be counterbalanced with the use of a Latin Square design (Williams 1949). Participants will be randomly allocated to a treatment order as selected through a Williams Latin Square. Participants will be required to undergo a screening/training visit, followed by three measurement visits at weekly intervals. The trial will last for 3 months in total, which is about 2-3 weeks for each participants.

Treatment Five different cultivars of date fruit were initially considered and screened for testing against cognitive performance and mood according to the following criteria; popularity, representation of the different maturation stages, and representation of the different colours, which has a great an effect on the total phenolic content. Therefore from the Bisir maturation stage Khasab and Birhi dates were chosen, from the Rutab maturation stage Sukari dates and Ajwah and Khalas dates were chosen from the Tamer maturation stage.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •A total of 36 healthy participants aged between 18 and 35 will be recruited through advertisement via poster and flyer. All participants will be required to undergo a screening visit.

排除标准

  • •Healthy participants aged 18-35 with a BMI >18 <36 will be recruited from the Newcastle Upon-Tyne area
  • •Participants will be considered ineligible to participate in the study if they meet any of the following criteria:
  • •They have a BMI above 35kg/m2 or lower than 18kg/m2
  • •They smoke or consume tobacco products
  • •They are taking any illicit or prescribed drugs
  • •They are using dietary supplements, over the counter medicine or recreational drugs
  • •They have a history of or currently abuse alcohol
  • •They have a history of dyslexia, ADHD, learning difficulties or color blindness
  • •They are females who are pregnant, seeking to become pregnant or do not use
  • •They have allergies to any food products.
  • •They have any metabolic diseases such as type 1 or type 2 diabetes.

研究组 & 干预措施

Birhi date cultivar

Experimental

A 48.46 g of freeze dried powder of Birhi date Cultivar which is equivalent to a 115g of fresh dates, contains 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and a total phenolic content of 162.8 mg/100 g of GAE. and 0.80 g of fibres, will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.

干预措施: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance (Dietary Supplement)

Khassab date cultivar

Experimental

A 34.5 g of freeze dried powder of Khassab date Cultivar which is equivalent to A 115g of fresh dates, contains 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and a total phenolic content of 91.52 mg/100 g of GAE. and 0.80 g of fibres,will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.

干预措施: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance (Dietary Supplement)

placebo

Placebo Comparator

A 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and 0.80 g of fibres, will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.

干预措施: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance (Dietary Supplement)

结局指标

主要结局

Cognition: Digit Vigilance

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition: Numeric Working Memory

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition: Spatial Working Memory

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

cognition: Simple Reaction Time

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition: Immediate Word Recall

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition:Word Recognition

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition:Pattern Separation

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition: Choice Reaction Time

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Cognition:Delayed Word Recall

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Cog-track an online set of nine cognitive tests (www.wesnes.com).

Mood scales Bond Lader

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

The Bond and Lader Visual Analogue Scales (1974)

The Profile of Mood States (POMS)

时间窗: Change from visit 1 to visit 2 to visit 3

The Profile of Mood States (POMS; McNair et al., 1992)

Blood Glucose level test

时间窗: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Finger prick

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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