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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
Date last updated
19/03/2024

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
Recruiting
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
30/12/2025
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
Stroke is a strong risk factor for dementia, with up to 80% of individuals having lower cognitive function 5 years after a stroke event. However, having a stroke does not need to result in declining cognition if effective strategies to reduce the risk of post stroke dementia are identified. Diets containing nuts can reduce the risk of both dementia and stroke but have not been tested in stroke survivors. Therefore, this pilot study aims to determine whether eating nuts regularly reduces post-stroke cognitive decline and dementia. The NUT-me pilot study will supplement the diet of stroke survivors with a mix of nuts containing walnuts, hazelnuts, almonds and Brazil nuts for 3 months and assess the effects on cognition and health markers. The researchers predict that regular nut consumption will contribute to preserving post-stroke cognitive function in comparison to patients who do not consume nuts. The results of this novel pilot study will be used to guide a larger trial and provide a simple dietary strategy that stroke survivors can adopt to reduce post-stroke cognitive decline.
Trial website
https://clinicaltrials.gov/study/NCT05902767
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/study/NCT05902767