Effect of Morning Snack on Cognitive Performance in Adults
Effect of Mid-morning Snacks on Cognitive Performance, Satiety, Food Intake, and Glycemic Response in Normal Weight Adults
1 other identifier
interventional
26
1 country
1
Brief Summary
To characterize the effects of three chocolate snacks on cognitive performance, subjective appetite, food intake control, and glycemic response in normal weight adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2018
CompletedFirst Submitted
Initial submission to the registry
August 16, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedMay 21, 2019
May 1, 2019
6 months
August 16, 2018
May 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (5)
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 subjective average appetite
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
Study Arms (4)
Control
PLACEBO COMPARATOR250 mL of water
White Chocolate
ACTIVE COMPARATORWhite chocolate (40 g)
Dark chocolate 1
EXPERIMENTALDark chocolate (40 g)
Dark chocolate 2
EXPERIMENTALDark chocolate (46 g) possibly containing caffeine and/or theobromine
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Nutrition, Ryerson University
Toronto, Ontario, M5B 2K3, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Bellissimo, PhD
Toronto Metropolitan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- treatments are in individual packages labelled "A", "B" and "C". Study participants and investigators are blinded to the composition of the test treatments.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 16, 2018
First Posted
August 20, 2018
Study Start
March 5, 2018
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
May 21, 2019
Record last verified: 2019-05