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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06343142




Registration number
NCT06343142
Ethics application status
Date submitted
27/03/2024
Date registered
2/04/2024
Date last updated
4/04/2024

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
Not Applicable
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06343142
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06343142