fatty acid/flavonoid blend
Dietary Supplementsee arm description
NCT Number: NCT02525198
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).
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Notify Me55 year and older
All sexes
Interventional
Not applicable
Centre for Human Psychopharmacology, Swinburne Univerity of Technology, Melbourne, Victoria, Australia
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see arm description
see arm description
Time frame: 12 months
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
To be measured on magnetic resonance imaging
Time frame: 12 months
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
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
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
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
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 12 months
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 12 months
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 12 months
Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
Time frame: 12 months
To be measured on spectroscopy
Time frame: 8 minutes
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.
University of East Anglia
Other
A Randomised Controlled Trial in 'At Risk' Humans Investigating the Cognitive Benefits of a Combined Flavonoid/Fatty Acid Intervention and Underlying Mechanisms of Action: The COGNITIVE AGING NUTRITION and NEUROGENESIS (CANN) Trial
Acronym: CANN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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