Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me)

Monash University

Status: Suspended

Conditions: Stroke; Dementia

Treatments: Other: Control; Other: Nuts

Study type: Interventional

Funder types: Other

Identifiers

NCT05902767

NUT-me

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Nut Group

Experimental group

Description:

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.

Treatment:

Other: Nuts

Control Group

Other group

Description:

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

Treatment:

Other: Control