Clinical trial NCT02525198: The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Subjective Memory Impairment
Keywords: Mild cognitive impairment
Subjective memory impairment
Dementia
Flavonoids
Fatty acids
Cognition
Gut microflora
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Swinburne University of Technology
name: University of Illinois at Chicago
First posted: 2015-08-17
Enrollment: 259
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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).

Eligibility criteria: 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

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

Primary outcomes:
measure: Number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System
timeFrame: 12 months
Secondary outcomes:
measure: Hippocampal volume
timeFrame: 12 months
measure: Gut microflora speciation and metabolism
timeFrame: 12 months
measure: Association between baseline APOE status and number of false positive responses during the picture recognition task of the CDR Computerized Cognitive Assessment System
timeFrame: 12 months
measure: Circulating biomarkers of cognition
timeFrame: 12 months
measure: Circulating biomarkers of cardiovascular health
timeFrame: 12 months
measure: Language ability on the Boston Naming Test
timeFrame: 12 months
measure: Visuospatial ability on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Figure Copy test
timeFrame: 12 months
measure: Attention ability on the Digit Span task
timeFrame: 12 months
measure: Executive function on the Trail Making Task
timeFrame: 12 months
measure: Cerebrovascular blood flow
timeFrame: 12 months
measure: Measurement of blood brain barrier permeability
timeFrame: 8 minutes
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Beckman Institute, University of Illinois
state: Illinois
city: Melbourne
country: Australia
facility: Centre for Human Psychopharmacology, Swinburne Univerity of Technology
state: Victoria
city: Norwich
country: United Kingdom
facility: Department of Nutrition, University of East Anglia
state: Norfolk
Study officials:
affiliation: Department of Nutrition, University of East Anglia, Norwich, U.K.
name: Anne Marie Minihane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Human Psychopharmacology, Swinburne University of Technology
name: Andrew Scholey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Institute, University of Illinois
name: Neal J Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.