StrokeNUT-meNCT05902767
Nut Supplementation to Mitigate Post-stroke Cognitive Decline
A study testing Nuts in people with Stroke and Dementia, run by Monash University at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Nuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2023to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Nutrition, Dietetics and Food - Monash University
Melbourne, Victoria, 3168
About this study
Official title: Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study
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.
Read the 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.
- Being tested
- Nuts, Control
- Keywords
- dementia, cognitive decline, nuts
- Medical subject headings
- Stroke, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutsOther
- 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
ControlOther
- Dietary counselling on how to follow the Australian Dietary Guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 90 days
% body fat
Changes in % body fat measured using bioelectrical Impedance Analysis (BIA)
Measured: 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.
Measured: 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.
Measured: 90 days
Blood lipids
Changes in total cholesterol, LDL, HDL and triglycerides
Measured: 90 days
Inflammatory markers
Changes in the composite of the following inflammatory markers: IL-6, IL-1β, IL-8, IL-10, and IL-1ra
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start30 Jun 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Recruitment has been extremely challenging.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomly assigned to one of the two study groups: Nuts of Control.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara R. Cardoso, Monash University
- Investigators
- Barbara R Cardoso, PhD, Principal investigator, Department of Nutrition, Dietetics and Food - Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902767
- Sponsor's protocol ID
- NUT-me
- Acronym
- NUT-me
- Status last verified
- Nov 2024
- First submitted
- 18 May 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nut Supplementation to Mitigate Post-stroke Cognitive Decline (NUT-me): a Pilot Study
- ClinicalTrials.gov ID
- NCT05902767
- Acronym / sponsor ID
- NUT-me / NUT-me
- Keywords
- dementia, cognitive decline, nuts
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has been extremely challenging.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be randomly assigned to one of the two study groups: Nuts of Control.
| Arm | Type | Receives |
|---|---|---|
| Nut Group | Experimental | Other: NutsParticipants 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. |
| Control Group | Other | Other: ControlParticipants 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Nut Group |
| Control- Dietary counselling on how to follow the Australian Dietary Guidelines | Other | Control Group |
Primary outcome
Cognitive Function Composite Score
Time frame: 90 days
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.
7 secondary outcomes
Fluid Cognition Composite Score
Time frame: 90 days
Crystallized Cognition Composite Score
Time frame: 90 days
% body fat
Time frame: 90 days
Depressive symptoms
Time frame: 90 days
HOMA-IR
Time frame: 90 days
Blood lipids
Time frame: 90 days
Inflammatory markers
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara R Cardoso, PhD principal investigator
Department of Nutrition, Dietetics and Food - Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuts in people with Stroke and Dementia, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function Composite Score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.