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

Primary Purpose

Stroke, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Nuts
Control
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring dementia, cognitive decline, nuts

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Nutrition, Dietetics and Food - Monash UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Nut Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
% body fat
Changes in % body fat measured using bioelectrical Impedance Analysis (BIA)
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.
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.
Blood lipids
Changes in total cholesterol, LDL, HDL and triglycerides
Inflammatory markers
Changes in the composite of the following inflammatory markers: IL-6, IL-1β, IL-8, IL-10, and IL-1ra

Full Information

First Posted
May 18, 2023
Last Updated
October 24, 2023
Sponsor
Monash University
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1. Study Identification

Unique Protocol Identification Number
NCT05902767
Brief Title
Nut Supplementation to Mitigate Post-stroke Cognitive Decline
Acronym
NUT-me
Official Title
Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dementia
Keywords
dementia, cognitive decline, nuts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be randomly assigned to one of the two study groups: Nuts of Control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nut Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Nuts
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
- Dietary counselling on how to follow the Australian Dietary Guidelines
Primary Outcome Measure Information:
Title
Cognitive Function Composite Score
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Fluid Cognition Composite Score
Description
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.
Time Frame
90 days
Title
Crystallized Cognition Composite Score
Description
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.
Time Frame
90 days
Title
% body fat
Description
Changes in % body fat measured using bioelectrical Impedance Analysis (BIA)
Time Frame
90 days
Title
Depressive symptoms
Description
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.
Time Frame
90 days
Title
HOMA-IR
Description
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.
Time Frame
90 days
Title
Blood lipids
Description
Changes in total cholesterol, LDL, HDL and triglycerides
Time Frame
90 days
Title
Inflammatory markers
Description
Changes in the composite of the following inflammatory markers: IL-6, IL-1β, IL-8, IL-10, and IL-1ra
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara R Cardoso, PhD
Phone
+61499840472
Email
barbara.cardoso@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara R Cardoso, PhD
Organizational Affiliation
Department of Nutrition, Dietetics and Food - Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Dietetics and Food - Monash University
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara R Cardoso, PhD
Phone
+61499840472
Email
barbara.cardoso@monash.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a small pilot study and the generated data will be used only by the Principal Investigator as preliminary data in grant applications and potentially one publication (yet to be decided).

Learn more about this trial

Nut Supplementation to Mitigate Post-stroke Cognitive Decline

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