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Completed

NCT Number: NCT03637829

Effect of Morning Snack on Cognitive Performance in Adults

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

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Key information

Conditions

Nutrition Cognitive Change Food Intake Control Satiety

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Control

Other

Water

white chocolate

Other

Experimental snack treatment

Dark chocolate 1

Other

Experimental snack treatment

Dark chocolate 2

Other

Experimental snack treatment

Primary outcomes

  1. Verbal declarative memory

    Time frame: 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

  2. Change from baseline spatial memory

    Time frame: 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.

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

    Time frame: 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.

  4. Change from baseline executive function

    Time frame: 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.

  5. Change from baseline working memory and executive function

    Time frame: 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.

  6. Change from baseline attention and reaction time

    Time frame: 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.

Secondary outcomes

  1. Change from baseline subjective average emotions

    Time frame: At Baseline, 15, 30, 45, 60, 75 and 90 minutes

    Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings.

  2. Change from baseline global vigor

    Time frame: At Baseline, 15, 30, 45, 60, 75 and 90 minutes

    Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings.

  3. Change from baseline subjective average appetite

    Time frame: At Baseline, 15, 30, 45, 60, 75 and 90 minutes

    Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings.

  4. Change from baseline blood glucose concentration

    Time frame: At Baseline, 15, 30, 45, 60, 75 and 90 minutes

    Blood glucose concentration (mmol/L) will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)

  5. Food intake

    Time frame: At 90 minutes

    After other measures at the 90 minute time-point, participants will have lunch and food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to kilocalories

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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