Cognitive PerformanceNCT06343142
Effects of Time of Day and Nut Intake on Cognitive Performance
A study testing Nuts and Nut-free meal in people with Cognitive Performance, run by Monash University at 1 site in Australia.
Trial summary
This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance
- What is being tested?
- Nuts and Nut-free meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Apr 2024to 1 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-shift workers
- 18-55 years
- BMI between 18.5 and 27 kg/m2,
- Non-smokers
- Without chronic illnesses
Who cannot join
- Allergy to nuts
- BMI<18.5 or >27 kg/m2
- Presence of dementia or psychiatric disease (depression, Parkinson's disease, schizophrenia)
- Presence of diabetes, serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery, cardiovascular disease
- Presence of any sleep disorders
- Taking anti-diabetic or lipid-lowering medication
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- Do not speak English
- Pregnant or planning on becoming pregnant
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Nutrition, Dietetics and Food - Monash University
Notting Hill, Victoria, 3168
About this study
Official title: Effects of Time of Day and Nut Intake on Cognitive Performance: a Crossover Trial in Healthy Adults
This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance.
Read the detailed description
In this trial, eligible participants will receive isocaloric meals with or without nuts at lunchtime and dinner time. Cognitive performance will be performed before and 90 min after the meals.
- Conditions
- Cognitive Performance
- Being tested
- Nuts, Nut-free meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutsOther
Isocaloric meal with nuts
Nut-free mealOther
Isocaloric meal without nuts
| Study group | Role | What they receive |
|---|---|---|
| Lunch nut-free meal | Placebo comparator | Participants will receive an isocaloric meal without nuts at lunchtime. Receives: Other: Nut-free meal |
| Lunch nut meal | Experimental | Participants will receive an isocaloric meal with nuts at lunchtime. Receives: Other: Nuts |
| Dinner nut-free meal | Placebo comparator | Participants will receive an isocaloric meal without nuts at dinner. Receives: Other: Nut-free meal |
| Dinner nut meal | Experimental | Participants will receive an isocaloric meal with nuts at dinner. Receives: Other: Nuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-back task - accuracy
Difference in the total accuracy
Measured: before meal x 90 min post-meal
N-back task - matched responses
Difference in the % matched responses
Measured: before meal x 90 min post-meal
N-back task - false alarm
Difference in the % false alarm
Measured: before meal x 90 min post-meal
N-back task - reaction time
Difference in the reaction time for correct matched responses
Measured: before meal x 90 min post-meal
Stroop test - congruent
Difference in the reaction time for congruent
Measured: before meal x 90 min post-meal
Stroop test - incongruent
Difference in the reaction time for incongruent
Measured: before meal x 90 min post-meal
Stroop test - interference
Difference in stroop interference (incongruent - congruent response time)
Measured: before meal x 90 min post-meal
Secondary outcomes (8)
Multitasking - pure blocks
Difference in the reaction time for pure blocks
Measured: before meal x 90 min post-meal
Multitasking - mixed blocks
Difference in the reaction time for mixed blocks
Measured: before meal x 90 min post-meal
Multitasking - mixing cost
Difference in mixing cost (mixed - pure reaction time)
Measured: before meal x 90 min post-meal
Satiety - hunger
Difference in postprandial hunger
Measured: Hunger will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - fullness
Difference in postprandial fullness
Measured: Fullness will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - satisfaction
Difference in postprandial satisfaction
Measured: Satisfaction will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - eating capacity
Difference in postprandial eating capacity,
Measured: Eating capacity will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety index
Difference in postprandial satiety index, calculated using the mean of the four satiety questions, where "hunger" and "eating capacity" will be scored in an inverse way than "fullness" and "satisfaction".
Measured: Satiety index will be assessed before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start8 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2 x 2-factor crossover design study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara R. Cardoso, Monash University
- Investigators
- Barbara R Cardoso, PhD, Principal investigator, Department of Nutrition, Dietetics and Food - Monash UniversityMaxine Bonham, PhD, Principal investigator, Department of Nutrition, Dietetics and Food - Monash UniversityHelen Macpherson, PhD, Principal investigator, Deakin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343142
- Sponsor's protocol ID
- Nuts for thought
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time of Day and Nut Intake on Cognitive Performance: a Crossover Trial in Healthy Adults
- ClinicalTrials.gov ID
- NCT06343142
- Acronym / sponsor ID
- Nuts for thought
- Conditions
- Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 2 Apr 2024 (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.
This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance.
Detailed description
In this trial, eligible participants will receive isocaloric meals with or without nuts at lunchtime and dinner time. Cognitive performance will be performed before and 90 min after the meals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2 x 2-factor crossover design study
| Arm | Type | Receives |
|---|---|---|
| Lunch nut-free meal | Placebo comparator | Other: Nut-free mealParticipants will receive an isocaloric meal without nuts at lunchtime. |
| Lunch nut meal | Experimental | Other: NutsParticipants will receive an isocaloric meal with nuts at lunchtime. |
| Dinner nut-free meal | Placebo comparator | Other: Nut-free mealParticipants will receive an isocaloric meal without nuts at dinner. |
| Dinner nut meal | Experimental | Other: NutsParticipants will receive an isocaloric meal with nuts at dinner. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-shift workers
- 18-55 years
- BMI between 18.5 and 27 kg/m2,
- Non-smokers
- Without chronic illnesses
Key exclusion criteria (9 listed)
- Allergy to nuts
- BMI<18.5 or >27 kg/m2
- Presence of dementia or psychiatric disease (depression, Parkinson's disease, schizophrenia)
- Presence of diabetes, serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery, cardiovascular disease
- Presence of any sleep disorders
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 |
|---|---|---|
| NutsIsocaloric meal with nuts | Other | Dinner nut meal, Lunch nut meal |
| Nut-free mealIsocaloric meal without nuts | Other | Dinner nut-free meal, Lunch nut-free meal |
Primary outcome
N-back task - accuracy
Time frame: before meal x 90 min post-meal
Difference in the total accuracy
N-back task - matched responses
Time frame: before meal x 90 min post-meal
Difference in the % matched responses
N-back task - false alarm
Time frame: before meal x 90 min post-meal
Difference in the % false alarm
N-back task - reaction time
Time frame: before meal x 90 min post-meal
Difference in the reaction time for correct matched responses
Stroop test - congruent
Time frame: before meal x 90 min post-meal
Difference in the reaction time for congruent
Stroop test - incongruent
Time frame: before meal x 90 min post-meal
Difference in the reaction time for incongruent
Stroop test - interference
Time frame: before meal x 90 min post-meal
Difference in stroop interference (incongruent - congruent response time)
8 secondary outcomes
Multitasking - pure blocks
Time frame: before meal x 90 min post-meal
Multitasking - mixed blocks
Time frame: before meal x 90 min post-meal
Multitasking - mixing cost
Time frame: before meal x 90 min post-meal
Satiety - hunger
Time frame: Hunger will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - fullness
Time frame: Fullness will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - satisfaction
Time frame: Satisfaction will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - eating capacity
Time frame: Eating capacity will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety index
Time frame: Satiety index will be assessed before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Barbara R Cardoso, PhD principal investigator
Department of Nutrition, Dietetics and Food - Monash University
Maxine Bonham, PhD principal investigator
Department of Nutrition, Dietetics and Food - Monash University
Helen Macpherson, PhD principal investigator
Deakin 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 Nuts and Nut-free meal in people with Cognitive Performance, run by Monash University at 1 site in Australia.
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 9 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 22 Nov 2024. 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 Australia. 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?
N-back task - accuracy (time frame: before meal x 90 min post-meal). The study lists 7 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 22 Nov 2024.