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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
259
see arm description
see arm description
Beckman Institute, University of Illinois
Urbana, Illinois, United States
Centre for Human Psychopharmacology, Swinburne Univerity of Technology
Melbourne, Victoria, Australia
Department of Nutrition, University of East Anglia
Norwich, Norfolk, United Kingdom
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.
Time frame: 12 months
Hippocampal volume
To be measured on magnetic resonance imaging
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 12 months
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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)
Time frame: 12 months
Language ability on the Boston Naming Test
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 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)
Time frame: 12 months
Attention ability on the Digit Span task
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 12 months
Executive function on the Trail Making Task
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 12 months
Cerebrovascular blood flow
To be measured on spectroscopy
Time frame: 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.
Time frame: 8 minutes