Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06343142




Registration number
NCT06343142
Ethics application status
Date submitted
27/03/2024
Date registered
2/04/2024

Titles & IDs
Public title
Effects of Time of Day and Nut Intake on Cognitive Performance
Scientific title
Effects of Time of Day and Nut Intake on Cognitive Performance: a Crossover Trial in Healthy Adults
Secondary ID [1] 0 0
42038
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Performance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nuts
Other interventions - Nut-free meal

Placebo comparator: Lunch nut-free meal - Participants will receive an isocaloric meal without nuts at lunchtime.

Experimental: Lunch nut meal - Participants will receive an isocaloric meal with nuts at lunchtime.

Placebo comparator: Dinner nut-free meal - Participants will receive an isocaloric meal without nuts at dinner.

Experimental: Dinner nut meal - Participants will receive an isocaloric meal with nuts at dinner.


Other interventions: Nuts
Isocaloric meal with nuts

Other interventions: Nut-free meal
Isocaloric meal without nuts
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
N-back task - accuracy
Timepoint [1] 0 0
before meal x 90 min post-meal
Primary outcome [2] 0 0
N-back task - matched responses
Timepoint [2] 0 0
before meal x 90 min post-meal
Primary outcome [3] 0 0
N-back task - false alarm
Timepoint [3] 0 0
before meal x 90 min post-meal
Primary outcome [4] 0 0
N-back task - reaction time
Timepoint [4] 0 0
before meal x 90 min post-meal
Primary outcome [5] 0 0
Stroop test - congruent
Timepoint [5] 0 0
before meal x 90 min post-meal
Primary outcome [6] 0 0
Stroop test - incongruent
Timepoint [6] 0 0
before meal x 90 min post-meal
Primary outcome [7] 0 0
Stroop test - interference
Timepoint [7] 0 0
before meal x 90 min post-meal
Secondary outcome [1] 0 0
Multitasking - pure blocks
Timepoint [1] 0 0
before meal x 90 min post-meal
Secondary outcome [2] 0 0
Multitasking - mixed blocks
Timepoint [2] 0 0
before meal x 90 min post-meal
Secondary outcome [3] 0 0
Multitasking - mixing cost
Timepoint [3] 0 0
before meal x 90 min post-meal
Secondary outcome [4] 0 0
Satiety - hunger
Timepoint [4] 0 0
Hunger will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Secondary outcome [5] 0 0
Satiety - fullness
Timepoint [5] 0 0
Fullness will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Secondary outcome [6] 0 0
Satiety - satisfaction
Timepoint [6] 0 0
Satisfaction will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Secondary outcome [7] 0 0
Satiety - eating capacity
Timepoint [7] 0 0
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).
Secondary outcome [8] 0 0
Satiety index
Timepoint [8] 0 0
Satiety index will be assessed before the meal and 4 times after the meal (15, 30, 60 and 90 mins).

Eligibility
Key inclusion criteria
* Non-shift workers
* 18-55 years
* BMI between 18.5 and 27 kg/m2,
* Non-smokers
* Without chronic illnesses
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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
* Do not speak English
* Pregnant or planning on becoming pregnant
* Breastfeeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Nutrition, Dietetics and Food - Monash University - Notting Hill
Recruitment postcode(s) [1] 0 0
3168 - Notting Hill

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara R Cardoso, PhD
Address 0 0
Department of Nutrition, Dietetics and Food - Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Barbara R Cardoso, PhD
Address 0 0
Country 0 0
Phone 0 0
+61499840472
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06343142