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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03637829
Other study ID # Ryerson-REB-2017-339
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2018
Est. completion date September 1, 2018

Study information

Verified date May 2019
Source Ryerson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Control
Water
White chocolate
Experimental snack treatment
Dark chocolate 1
Experimental snack treatment
Dark chocolate 2
Experimental snack treatment

Locations

Country Name City State
Canada School of Nutrition, Ryerson University Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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