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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05902767




Registration number
NCT05902767
Ethics application status
Date submitted
18/05/2023
Date registered
15/06/2023

Titles & IDs
Public title
Nut Supplementation to Mitigate Post-stroke Cognitive Decline
Scientific title
Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study
Secondary ID [1] 0 0
NUT-me
Universal Trial Number (UTN)
Trial acronym
NUT-me
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Dementia 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders

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

Experimental: Nut Group - Participants will receive a supply of mixed nuts containing: 1 Brazil nut (\~3g), walnuts (15g), hazelnuts (7g), and almonds (7g) to be consumed daily for 90 days. They will also receive dietary counselling on how to follow the Australian Dietary Guidelines.

Other: Control Group - Participants will follow the same protocol as the Nut group regarding appointments and collection of information. At the visits, they will receive dietary counselling on how to follow the Australian Dietary Guidelines


Other interventions: Nuts
* A mix of nuts containing 1 Brazil nut (\~3g), walnuts (15g), hazelnuts (7g), and almonds (7g) to be consumed daily for 90 days.
* Dietary counselling on how to follow the Australian Dietary Guidelines

Other interventions: Control
- Dietary counselling on how to follow the Australian Dietary Guidelines
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cognitive Function Composite Score
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Fluid Cognition Composite Score
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
Crystallized Cognition Composite Score
Timepoint [2] 0 0
90 days
Secondary outcome [3] 0 0
% body fat
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Depressive symptoms
Timepoint [4] 0 0
90 days
Secondary outcome [5] 0 0
HOMA-IR
Timepoint [5] 0 0
90 days
Secondary outcome [6] 0 0
Blood lipids
Timepoint [6] 0 0
90 days
Secondary outcome [7] 0 0
Inflammatory markers
Timepoint [7] 0 0
90 days

Eligibility
Key inclusion criteria
* Ischaemic stroke (first or recurrent stroke) in the last 6 months
* Able to attend 4 study visits over 3 months
* Motivation and willingness to participate in the study protocol
* No prior neurological or psychiatric disease, including dementia
* Can give informed consent and participate in cognitive testing
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* be < 18 years;
* have allergy to nuts
* have premorbid modified Rankin scale (mRS)=4, denoting no severe disability
* incapable of giving consent
* have problems with mastication that preclude nut intake
* have habitual consumption of tree nuts (>2 servings/wk) in the previous 2 months
* have habitual consumption of alpha-linolenic acid supplements (fish oil, flaxseed oil, and/or soy lecithin)
* have dementia or psychiatric disease
* do not speak English

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Nutrition, Dietetics and Food - Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Melbourne

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
barbara.cardoso@monash.edu
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
This is a small pilot study and the generated data will be used only by the Principal Investigator as preliminary data in grant applications and potentially one publication (yet to be decided).


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/NCT05902767