Clinical trial NCT05902767: Nut Supplementation to Mitigate Post-stroke Cognitive Decline
Official title: Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Dementia
Keywords: dementia
cognitive decline
nuts
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly assigned to one of the two study groups: Nuts of Control.
Primary purpose: TREATMENT

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.

Detailed description: This study will investigate the efficacy and feasibility of supplementing the habitual diet of stroke survivors with a supply of mixed nuts containing Brazil nut, walnuts, hazelnuts, and almonds to reduce post-stroke cognitive decline. The overall aim of this project will be achieved through the following objectives:

* Examine the feasibility through the assessment of compliance with the intervention and participants' perception of the study
* Investigate the efficacy of the intervention on cognitive decline, body composition and health outcomes (blood pressure, fasting glucose and insulin, and blood lipids) The investigators hypothesise that the inclusion of nuts is a simple dietary strategy that will slow post-stroke cognitive decline and that supplementation with nuts will improve body composition and health biomarkers of stroke survivors.

Eligibility criteria: 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

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

Primary outcomes:
measure: Cognitive Function Composite Score
timeFrame: 90 days
Secondary outcomes:
measure: Fluid Cognition Composite Score
timeFrame: 90 days
measure: Crystallized Cognition Composite Score
timeFrame: 90 days
measure: % body fat
timeFrame: 90 days
measure: Depressive symptoms
timeFrame: 90 days
measure: HOMA-IR
timeFrame: 90 days
measure: Blood lipids
timeFrame: 90 days
measure: Inflammatory markers
timeFrame: 90 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Department of Nutrition, Dietetics and Food - Monash University
state: Victoria
Study officials:
affiliation: Department of Nutrition, Dietetics and Food - Monash University
name: Barbara R Cardoso, PhD
role: PRINCIPAL_INVESTIGATOR
References: