NutritionNCT03637829
Effect of Morning Snack on Cognitive Performance in Adults
A study testing White chocolate, Dark chocolate 1 and Dark chocolate 2 in people with Nutrition and Cognitive Change, run by Toronto Metropolitan University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Cognitive Change, Food Intake Control
- What is being tested?
- White chocolate, Dark chocolate 1 and Dark chocolate 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2018to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition, Cognitive Change, Food Intake Control, Satiety
- Being tested
- Control, White chocolate, Dark chocolate 1, Dark chocolate 2
- Keywords
- Healthy adults, Cognitive performance, Chocolate, Food intake, Glycemic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Water
White chocolateOther
Experimental snack treatment
Dark chocolate 1Other
Experimental snack treatment
Dark chocolate 2Other
Experimental snack treatment
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 250 mL of water Receives: Other: Control |
| White Chocolate | Active comparator | White chocolate (40 g) Receives: Other: White chocolate |
| Dark chocolate 1 | Experimental | Dark chocolate (40 g) Receives: Other: Dark chocolate 1 |
| Dark chocolate 2 | Experimental | Dark chocolate (46 g) possibly containing caffeine and/or theobromine Receives: Other: Dark chocolate 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline, 15, 45, and 75 minutes
Secondary outcomes (5)
Change from baseline subjective average emotions
Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings.
Measured: At Baseline, 15, 30, 45, 60, 75 and 90 minutes
Change from baseline global vigor
Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings.
Measured: At Baseline, 15, 30, 45, 60, 75 and 90 minutes
Change from baseline subjective average appetite
Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings.
Measured: At Baseline, 15, 30, 45, 60, 75 and 90 minutes
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)
Measured: At Baseline, 15, 30, 45, 60, 75 and 90 minutes
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
Measured: At 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start5 Mar 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637829
- Sponsor's protocol ID
- Ryerson-REB-2017-339
- Status last verified
- May 2019
- First submitted
- 16 Aug 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mid-morning Snacks on Cognitive Performance, Satiety, Food Intake, and Glycemic Response in Normal Weight Adults
- ClinicalTrials.gov ID
- NCT03637829
- Acronym / sponsor ID
- Ryerson-REB-2017-339
- Conditions
- Nutrition, Cognitive Change, Food Intake Control, Satiety
- Keywords
- Healthy adults, Cognitive performance, Chocolate, Food intake, Glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control250 mL of water |
| White Chocolate | Active comparator | Other: White chocolateWhite chocolate (40 g) |
| Dark chocolate 1 | Experimental | Other: Dark chocolate 1Dark chocolate (40 g) |
| Dark chocolate 2 | Experimental | Other: Dark chocolate 2Dark chocolate (46 g) possibly containing caffeine and/or theobromine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlWater | Other | Control |
| White chocolateExperimental snack treatment | Other | White Chocolate |
| Dark chocolate 1Experimental snack treatment | Other | Dark chocolate 1 |
| Dark chocolate 2Experimental snack treatment | Other | Dark chocolate 2 |
Primary outcome
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 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.
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.
5 secondary outcomes
Change from baseline subjective average emotions
Time frame: 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
Change from baseline subjective average appetite
Time frame: 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
Food intake
Time frame: At 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Bellissimo, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White chocolate, Dark chocolate 1 and Dark chocolate 2 in people with Nutrition and Cognitive Change, run by Toronto Metropolitan University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal declarative memory (time frame: At 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.