Nut Supplementation to Mitigate Post-stroke Cognitive Decline

NCT05902767 | Suspended DMC

• 1 other identifier: NUT-me
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dementia

Keywords

dementia; cognitive decline; nuts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fluid Cognition Composite Score

  90 days

• Crystallized Cognition Composite Score

  90 days

• % body fat

  90 days

• Depressive symptoms

  90 days

• HOMA-IR

  90 days

Study Arms (2)

Nut Group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Nuts 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

Nut Group

Control OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Department of Nutrition, Dietetics and Food - Monash University

Melbourne, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Stroke; Dementia; Cognitive Dysfunction

Interventions

Nuts

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Barbara R Cardoso, PhD

  Department of Nutrition, Dietetics and Food - Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: The participants will be randomly assigned to one of the two study groups: Nuts of Control.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 15, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)