Nut Supplementation to Mitigate Post-stroke Cognitive Decline

Stroke Clinical Trial

— NUT-me  

Official title:

Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902767
• Other study ID #: NUT-me
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Monash University
• Contact: Barbara R Cardoso, PhD
• Phone: +61499840472
• Email: barbara.cardoso[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Stroke

Intervention

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
• Control
- Dietary counselling on how to follow the Australian Dietary Guidelines

Locations

Country	Name	City	State
Australia	Department of Nutrition, Dietetics and Food - Monash University	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	% body fat	Changes in % body fat measured using bioelectrical Impedance Analysis (BIA)	90 days
Secondary	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
Secondary	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
Secondary	Blood lipids	Changes in total cholesterol, LDL, HDL and triglycerides	90 days
Secondary	Inflammatory markers	Changes in the composite of the following inflammatory markers: IL-6, IL-1ß, IL-8, IL-10, and IL-1ra	90 days