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Nut Supplementation to Mitigate Post-stroke Cognitive Decline

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-06-30

Primary completion: 2025-06-30

Study completion finish: 2025-12-30

Study type

TREATMENT

Phase

Trial ID

NCT05902767

Intervention or treatment

OTHER: Nuts

OTHER: Control

Conditions

• Dementia
• Stroke

Condition: Dementia, Stroke
OTHER: Nuts and other drugs
Melbourne, Victoria, Australia
Sponsor: Monash University

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Department of Nutrition, Dietetics and Food - Monash University

Research sites nearby

Select from list below to view details:

Department of Nutrition, Dietetics and Food - Monash University
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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: 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: 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: Control - Dietary counselling on how to follow the Australian Dietary Guidelines

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Cognitive Function Composite Score	Cognitive performance after the 90-day intervention will be assessed in comparison to baseline by using the NIH Toolbox Cognition Battery V3. This validated battery encompasses 15 tests that are combined to generate composite scores by age: Crystalised Composite (which includes picture vocabulary and oral reading recognition tests) and Fluid Composite (which includes dimensional change card sort, flanker, picture sequence memory, list sorting, and pattern comparison tests).The Cognitive Function Composite Score is a combination of both crystallized and fluid scores. Higher scores indicate better cognitive performance.	90 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Fluid Cognition Composite Score	Cognitive performance after the 90-day intervention will be assessed in comparison to baseline by using the NIH Toolbox Cognition Battery V3. This validated battery encompasses 15 tests that are combined to generate composite scores by age: Crystalised Composite (which includes picture vocabulary and oral reading recognition tests) and Fluid Composite (which includes dimensional change card sort, flanker, picture sequence memory, list sorting, and pattern comparison tests).The Cognitive Function Composite Score is a combination of both crystallized and fluid scores. Higher scores indicate better cognitive performance.	90 days
Crystallized Cognition Composite Score	Cognitive performance after the 90-day intervention will be assessed in comparison to baseline by using the NIH Toolbox Cognition Battery V3. This validated battery encompasses 15 tests that are combined to generate composite scores by age: Crystalised Composite (which includes picture vocabulary and oral reading recognition tests) and Fluid Composite (which includes dimensional change card sort, flanker, picture sequence memory, list sorting, and pattern comparison tests).The Cognitive Function Composite Score is a combination of both crystallized and fluid scores. Higher scores indicate better cognitive performance.	90 days
% body fat	Changes in % body fat measured using bioelectrical Impedance Analysis (BIA)	90 days
Depressive symptoms	Changes in the presence of depressive symptoms assessed by Patient Health Questionnaire (PHQ-9). The score ranges from zero to 27, with higher scores indicating worse depressive symptoms.	90 days
HOMA-IR	HOMA-IR is a measure of insulin resistance. It is calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.	90 days
Blood lipids	Changes in total cholesterol, LDL, HDL and triglycerides	90 days
Inflammatory markers	Changes in the composite of the following inflammatory markers: IL-6, IL-1β, IL-8, IL-10, and IL-1ra	90 days

Frequently Asked Questions

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References

Clinical Trials Gov: Nut Supplementation to Mitigate Post-stroke Cognitive Decline