- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637829
Effect of Morning Snack on Cognitive Performance in Adults
May 19, 2019 updated by: Nick Bellissimo, Ryerson University
Effect of Mid-morning Snacks on Cognitive Performance, Satiety, Food Intake, and Glycemic Response in Normal Weight Adults
To characterize the effects of three chocolate snacks on cognitive performance, subjective appetite, food intake control, and glycemic response in normal weight adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
250 mL of water
|
Water
|
|
Active Comparator: White Chocolate
White chocolate (40 g)
|
Experimental snack treatment
|
|
Experimental: Dark chocolate 1
Dark chocolate (40 g)
|
Experimental snack treatment
|
|
Experimental: Dark chocolate 2
Dark chocolate (46 g) possibly containing caffeine and/or theobromine
|
Experimental snack treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
At 15 minutes
|
|
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.
|
At Baseline, 15, 45, and 75 minutes
|
|
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.
|
At 45 and 75 minutes
|
|
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.
|
At Baseline, 15, 45, and 75 minutes
|
|
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.
|
At Baseline, 15, 45, and 75 minutes
|
|
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.
|
At Baseline, 15, 45, and 75 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At Baseline, 15, 30, 45, 60, 75 and 90 minutes
|
|
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.
|
At Baseline, 15, 30, 45, 60, 75 and 90 minutes
|
|
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.
|
At Baseline, 15, 30, 45, 60, 75 and 90 minutes
|
|
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)
|
At Baseline, 15, 30, 45, 60, 75 and 90 minutes
|
|
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
|
At 90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2018
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
August 16, 2018
First Submitted That Met QC Criteria
August 16, 2018
First Posted (Actual)
August 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 21, 2019
Last Update Submitted That Met QC Criteria
May 19, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Ryerson-REB-2017-339
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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