NCT03637829

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

August 16, 2018

Last Update Submit

May 19, 2019

Conditions

Keywords

Healthy adultsCognitive performanceChocolateFood intakeGlycemic response

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 COMPARATOR

250 mL of water

Other: Control

White Chocolate

ACTIVE COMPARATOR

White chocolate (40 g)

Other: White chocolate

Dark chocolate 1

EXPERIMENTAL

Dark chocolate (40 g)

Other: Dark chocolate 1

Dark chocolate 2

EXPERIMENTAL

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

Other: Dark chocolate 2

Interventions

ControlOTHER

Water

Control

Experimental snack treatment

White Chocolate

Experimental snack treatment

Dark chocolate 1

Experimental snack treatment

Dark chocolate 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

Locations