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Clinical Trials/NCT03637829
NCT03637829CompletedNot Applicable

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

Toronto Metropolitan University1 site in 1 country26 target enrollmentStarted: March 5, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Change from baseline executive function

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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,
  • •diabetic or overweight/obese individuals.
  • •Restrained eating habits, defined as scoring greater than 11 points on the eating habits questionnaire

Arms & Interventions

Control

Placebo Comparator

250 mL of water

Intervention: Control (Other)

White Chocolate

Active Comparator

White chocolate (40 g)

Intervention: White chocolate (Other)

Dark chocolate 1

Experimental

Dark chocolate (40 g)

Intervention: Dark chocolate 1 (Other)

Dark chocolate 2

Experimental

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

Intervention: Dark chocolate 2 (Other)

Outcomes

Primary Outcomes

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.

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

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.

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.

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.

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

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nick Bellissimo

Associate Professor

Toronto Metropolitan University

Study Sites (1)

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