Nut Supplementation to Mitigate Post-stroke Cognitive Decline

NCT ID: NCT05902767

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2027-12-30

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.

Conditions

Stroke; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nuts

Intervention Type: OTHER

• 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 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

Group Type: OTHER

Control

Intervention Type: OTHER

\- Dietary counselling on how to follow the Australian Dietary Guidelines

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

Intervention Type: OTHER

Control

\- Dietary counselling on how to follow the Australian Dietary Guidelines

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Barbara R. Cardoso

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara R Cardoso, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Dietetics and Food - Monash University

Locations

Department of Nutrition, Dietetics and Food - Monash University

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

NUT-me

Identifier Type: -

Identifier Source: org_study_id