Effect of Morning Snack on Cognitive Performance in Adults

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

Detailed Description
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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.

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

Conditions
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Nutrition, Cognitive Change, Food Intake Control, Satiety

Intervention / Treatment
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* Other: Control
* Other: White chocolate
* Other: Dark chocolate 1
* Other: Dark chocolate 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A random and within subject, repeated measures experiment to study the effect of chocolate on cognitive performance, subjective appetite, food intake, and glycemic response in normal weight adults.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>250 mL of water | Other: Control<br>* Water<br>|
| Active Comparator: White Chocolate<br>White chocolate (40 g) | Other: White chocolate<br>* Experimental snack treatment<br>|
| Experimental: Dark chocolate 1<br>Dark chocolate (40 g) | Other: Dark chocolate 1<br>* Experimental snack treatment<br>|
| Experimental: Dark chocolate 2<br>Dark chocolate (46 g) possibly containing caffeine and/or theobromine | Other: Dark chocolate 2<br>* Experimental snack treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal declarative memory | 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 | At 15 minutes | 
| Change from baseline spatial memory | 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. | At Baseline, 15, 45, and 75 minutes | 
| Change in verbal declarative memory from the 15 minute time-point | 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. | At 45 and 75 minutes | 
| Change from baseline executive function | 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. | At Baseline, 15, 45, and 75 minutes | 
| Change from baseline working memory and executive function | 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. | At Baseline, 15, 45, and 75 minutes | 
| Change from baseline attention and reaction time | 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. | At Baseline, 15, 45, and 75 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline subjective average emotions | Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings. | At Baseline, 15, 30, 45, 60, 75 and 90 minutes | 
| Change from baseline global vigor | Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings. | At Baseline, 15, 30, 45, 60, 75 and 90 minutes | 
| Change from baseline subjective average appetite | Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings. | At Baseline, 15, 30, 45, 60, 75 and 90 minutes | 
| Change from baseline blood glucose concentration | Blood glucose concentration (mmol/L) will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH) | At Baseline, 15, 30, 45, 60, 75 and 90 minutes | 
| Food intake | 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 | At 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy adults, Cognitive performance, Chocolate, Food intake, Glycemic response