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临床试验/NCT03637829
NCT03637829已完成不适用

Effect of Mid-morning Snacks on Cognitive Performance, Satiety, Food Intake, and Glycemic Response in Normal Weight Adults

Toronto Metropolitan University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年3月5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
26
试验地点
1
主要终点
Change from baseline executive function

研究概览

简要总结

To characterize the effects of three chocolate snacks on cognitive performance, subjective appetite, food intake control, and glycemic response in normal weight adults.

详细描述

On 4 separate mornings, 7 days apart, 12 hours after an overnight fast, and 3 hours after a standardized breakfast of a cereal bar, orange juice and fruit cup, participants will consume isocaloric snacks of white chocolate, 2 types of dark chocolate or control (water), followed by an ad libitum pizza lunch 90 minutes later. Upon arrival, at baseline (0 minutes), participants will be asked to complete the motivation-to-eat, global vigor and subjective emotion visual analogue scales (VAS), a battery of cognitive performance tasks and have blood samples taken, as reported and validated in our previous studies. Over the 90 minute testing period, blood samples will be taken,the VAS questions will be completed and cognitive tasks will be completed. Cognitive performance assessments will include learning and memory, spatial memory, attention and processing speed, and executive functions. VAS measuring physical comfort is completed pre- and post-meal. Ad libitum food intake from a test meal will be measured.

研究设计

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

盲法说明

treatments are in individual packages labelled "A", "B" and "C". Study participants and investigators are blinded to the composition of the test treatments.

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

  • •be between 18 and 35 years of age
  • •be healthy and have a have body mass index (BMI) between 18.5 and 24.9
  • •not be taking any medications, not smoking, and
  • •not have allergies to chocolate, dairy or gluten
  • •be tested during the early follicular phase of their menstrual cycle for women

排除标准

  • •anyone with food sensitivities or allergies to chocolate, dairy or gluten,
  • •diabetic or overweight/obese individuals.
  • •Restrained eating habits, defined as scoring greater than 11 points on the eating habits questionnaire

研究组 & 干预措施

Control

Placebo Comparator

250 mL of water

干预措施: Control (Other)

White Chocolate

Active Comparator

White chocolate (40 g)

干预措施: White chocolate (Other)

Dark chocolate 1

Experimental

Dark chocolate (40 g)

干预措施: Dark chocolate 1 (Other)

Dark chocolate 2

Experimental

Dark chocolate (46 g) possibly containing caffeine and/or theobromine

干预措施: Dark chocolate 2 (Other)

结局指标

主要结局

Change from baseline executive function

时间窗: At Baseline, 15, 45, and 75 minutes

Will be assessed the Stroop task via the Membrain application. Participants will be presented with a list of words presented in colors that match the word (congruent, the word 'red' presented in red) or colors that do not match the word (incongruent, the word 'red' presented in blue). Participants will be asked to identify the color of the word, not the word itself. The task is scored for the number of correct and incorrect colors identified, as well as total time to completion. This test will be at each time-point and will take 1 minute to complete.

Verbal declarative memory

时间窗: At 15 minutes

One of six word lists composed of 15 words will be audio presented and participants will be asked to write them down. The word list will be presented 3 times and the participant will immediately write down words after each time the word list is presented. This test will take 5 minutes

Change from baseline spatial memory

时间窗: At Baseline, 15, 45, and 75 minutes

Assessed using a spatial pattern recognition test on the Membrain Application. There will be a grid of 9 boxes with circles randomly located inside each box. Participants will be asked to remember where circles are located in each box. This test is done 6 times at each time-point, with each test having different random locations of circles. Each test will take 20 seconds.

Change in verbal declarative memory from the 15 minute time-point

时间窗: At 45 and 75 minutes

Participants will be asked to recall and write down all the words from the word list presented at the 15 minute time-point. This test will take 2 minutes.

Change from baseline working memory and executive function

时间窗: At Baseline, 15, 45, and 75 minutes

A random 3 digit number will appear on the screen of the Membrain Application and the participant will have to continually subtract 3 from this number. At each time-point, participants will also complete the same test, except will subtract 7 continuously. This is a 2 minute test.

Change from baseline attention and reaction time

时间窗: At Baseline, 15, 45, and 75 minutes

Using the Membrain Application, Aa continuous string of single digit numbers appear on the screen, one at a time (each appearing for about one second). After seeing three consecutive ascending odd numbers, participants click the 'odd' button. When they see three consecutive, ascending even numbers, they click the 'even' button. When they see the number "1", they click the 'tertiary' button. This test is 5 minutes in length.

次要结局

  • Change from baseline subjective average appetite(At Baseline, 15, 30, 45, 60, 75 and 90 minutes)
  • Change from baseline subjective average emotions(At Baseline, 15, 30, 45, 60, 75 and 90 minutes)
  • Change from baseline global vigor(At Baseline, 15, 30, 45, 60, 75 and 90 minutes)
  • Change from baseline blood glucose concentration(At Baseline, 15, 30, 45, 60, 75 and 90 minutes)
  • Food intake(At 90 minutes)

研究者

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

Nick Bellissimo

Associate Professor

Toronto Metropolitan University

研究点 (1)

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