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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02525198
Registration number
NCT02525198
Ethics application status
Date submitted
11/05/2015
Date registered
17/08/2015
Date last updated
14/05/2024
Titles & IDs
Public title
The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial
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Scientific title
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
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Secondary ID [1]
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R21647
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Universal Trial Number (UTN)
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Trial acronym
CANN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment
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Subjective Memory Impairment
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - fatty acid/flavonoid blend
Treatment: Other - Placebo
Placebo comparator: Placebo - Placebo group: 12 month daily ingestion of placebo oil and flavonoid-poor matched extract
Experimental: fatty acid/flavonoid blend - Experimental group: 12 month daily ingestion of 1.5 g EPA+DHA and 500 mg flavonoids
Treatment: Other: fatty acid/flavonoid blend
see arm description
Treatment: Other: Placebo
see arm description
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Hippocampal volume
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Assessment method [1]
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To be measured on magnetic resonance imaging
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Gut microflora speciation and metabolism
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Assessment method [2]
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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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Timepoint [2]
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12 months
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Secondary outcome [3]
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Association between baseline APOE status and number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System
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Assessment method [3]
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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.
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Circulating biomarkers of cognition
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Assessment method [4]
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Biomarkers to include BDNF, ß-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine)
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Circulating biomarkers of cardiovascular health
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Assessment method [5]
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Biomarkers to include BDNF, ß-amyloid, plasma lipids, inflammatory markers, nitric oxide and fatty acids, flavonoids and their metabolites (plasma and urine)
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Language ability on the Boston Naming Test
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Assessment method [6]
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Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
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Timepoint [6]
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12 months
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Secondary outcome [7]
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Visuospatial ability on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Figure Copy test
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Assessment method [7]
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Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Attention ability on the Digit Span task
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Assessment method [8]
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Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Executive function on the Trail Making Task
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Assessment method [9]
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Allows for categorization according to cognitive status (mild cognitive impairment, dementia, subjective memory impairment)
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Timepoint [9]
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12 months
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Secondary outcome [10]
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Cerebrovascular blood flow
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Assessment method [10]
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To be measured on spectroscopy
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Measurement of blood brain barrier permeability
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Assessment method [11]
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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.
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Timepoint [11]
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8 minutes
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Eligibility
Key inclusion criteria
* Male and female, aged = 55 years
* Mild cognitive impairment (MCI) or subjective memory impairment (SMI) with no indication of clinical dementia or depression
* Willing and able to provide written informed consent.
* Understands and is willing and able to comply with all study procedures.
* Fluent in written and spoken English.
* In good general health including blood biochemical, haematological and urinalysis within the normal range at screening (as judged by the clinical advisor)
* Normal, or corrected to normal vision and hearing
* Right handed, for MRI
* Stable use of any prescribed medication for at least four weeks
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Diagnosis of Alzheimer's disease (AD) or other form of dementia or significant neurological disorder
* Parent or sibling who developed premature dementia <60y (suggestive of a familial monogenic form of cognitive decline)
* Past history or MRI evidence of brain damage including significant trauma, stroke, learning difficulties or serious neurological disorder, including loss of consciousness > 24 hours
* History of alcohol or drug dependency within the last 2 years
* Other clinically diagnosed psychiatric disorder likely to affect the cognitive measures (as judged by clinical adviser)
* Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids and fatty acids (as judged by clinical adviser)
* Major cardiovascular event, e.g. myocardial infarction or stroke, in the last 12 months
* Carotid stents or severe stenosis
* Known allergy to fish or any other component in the intervention supplements
* Existing medical conditions likely to affect the study measures (as judged by clinical adviser)
* Uncontrolled hypertension (Systolic Blood Pressure (SBP) >140mmHg, Diastolic Blood Pressure (DBP) >90mmHg)
* BMI >40kg/m2
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2018
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Sample size
Target
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Accrual to date
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Final
259
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Centre for Human Psychopharmacology, Swinburne Univerity of Technology - Melbourne
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Recruitment postcode(s) [1]
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3122 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United Kingdom
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State/province [2]
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Norfolk
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of East Anglia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Swinburne University of Technology
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Illinois at Chicago
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT02525198
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Anne Marie Minihane, PhD
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Address
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Department of Nutrition, University of East Anglia, Norwich, U.K.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02525198
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