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| Name | Class |
|---|---|
| Swinburne University of Technology | OTHER |
| University of Illinois at Chicago | OTHER |
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There is a dearth of research which takes a multi-compound approach to dietary interventions, in humans, aimed at improving outcome measures of cognition. Animal research in particular points towards fatty acids and flavonoids having a potentiating effect on each other, and possibly even being synergistic. Thus, study products will be administered in the present trial comprising both of these compounds, with a view to investigating their potential effects on cognition in older adults with mild cognitive impairment (MCI) or subjective memory impairment (SMI).
240 participants, aged 55 or above, will be recruited (120 Norwich, 120 Melbourne; to include both MCI and SCI participants).
Participants will be asked to take the study food each day for 12 months, and to come to the clinical assessment unit on 3 occasions, at baseline, 3 months and 12 months, to complete a cognitive task battery such that their performance may be investigated in the context of the intervention.
Urine, blood and faecal samples will be collected and magnetic resonance imaging (MRI) will be applicable to half of each population (i.e to 60 MCI and 60 SCI, 30 of each at Norwich and Melbourne).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo group: 12 month daily ingestion of placebo oil and flavonoid-poor matched extract |
|
| fatty acid/flavonoid blend | Experimental | Experimental group: 12 month daily ingestion of 1.5 g EPA+DHA and 500 mg flavonoids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fatty acid/flavonoid blend | Dietary Supplement | see arm description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System | The CDR Computerized Cognitive Assessment System will be used to measure the cognitive effects of the treatments. The battery is sensitive to bidirectional cognitive change including trials in MCI, dementia and SMI. There is strong converging evidence that one particular aspect of performance, namely the number of false positive responses during a picture recognition task, is particularly sensitive to hippocampal integrity (based on activation of the dentate gyrus during the task, and specific decrements in conditions associated with poorer hippocampal function). This will form the primary outcome in this study. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal volume | To be measured on magnetic resonance imaging | 12 months |
| Gut microflora speciation and metabolism | Measured in faecal samples. By extension, we also seek to consider the contribution of the microflora to cognition function and its response to treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Marie Minihane, PhD | Department of Nutrition, University of East Anglia, Norwich, U.K. | Principal Investigator |
| Andrew Scholey, PhD | Centre for Human Psychopharmacology, Swinburne University of Technology | Principal Investigator |
| Neal J Cohen, PhD | Beckman Institute, University of Illinois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Institute, University of Illinois | Urbana | Illinois | 61801 | United States | ||
| Centre for Human Psychopharmacology, Swinburne Univerity of Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37315924 | Derived | Vauzour D, Scholey A, White DJ, Cohen NJ, Cassidy A, Gillings R, Irvine MA, Kay CD, Kim M, King R, Legido-Quigley C, Potter JF, Schwarb H, Minihane AM. A combined DHA-rich fish oil and cocoa flavanols intervention does not improve cognition or brain structure in older adults with memory complaints: results from the CANN randomized, controlled parallel-design study. Am J Clin Nutr. 2023 Aug;118(2):369-381. doi: 10.1016/j.ajcnut.2023.06.008. Epub 2023 Jun 12. | |
| 30426067 |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| Placebo |
| Dietary Supplement |
see arm description |
|
| 12 months |
| Association between baseline APOE status and number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System | We will assess the impact of intervention in respect to presence or absence of APOE 4 gene across participants, which is a risk factor for dementia. | 12 months |
| Circulating biomarkers of cognition | Biomarkers to include BDNF, β-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine) | 12 months |
| Circulating biomarkers of cardiovascular health | Biomarkers to include BDNF, β-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine) | 12 months |
| Language ability on the Boston Naming Test | Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment) | 12 months |
| Visuospatial ability on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Figure Copy test | Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment) | 12 months |
| Attention ability on the Digit Span task | Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment) | 12 months |
| Executive function on the Trail Making Task | Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment) | 12 months |
| Cerebrovascular blood flow | To be measured on spectroscopy | 12 months |
| Measurement of blood brain barrier permeability | Allows testing of the hypothesis that the test food will help improve BBB permeability through its action on endothelial function. Six axial slices will be measured every 1.34 seconds for 8 minutes. | 8 minutes |
| Melbourne |
| Victoria |
| 3122 |
| Australia |
| Department of Nutrition, University of East Anglia | Norwich | Norfolk | NR4 7TJ | United Kingdom |
| Derived |
| Irvine MA, Scholey A, King R, Gillings R, Vauzour D, Demichele SJ, Das T, Wesnes KA, Sutton BP, Cassidy A, Pipingas A, Potter JF, Johnson G, White D, Larsen R, Cohen NJ, Minihane AM. The Cognitive Ageing, Nutrition and Neurogenesis (CANN) trial: Design and progress. Alzheimers Dement (N Y). 2018 Sep 5;4:591-601. doi: 10.1016/j.trci.2018.08.001. eCollection 2018. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |