The Cognitive Ageing Nutrition and Neurogenesis (CANN) Trial

University of East Anglia

Status: Completed

Conditions: Mild Cognitive Impairment; Subjective Memory Impairment

Treatments: Dietary Supplement: Placebo; Dietary Supplement: fatty acid/flavonoid blend

Study type: Interventional

Funder types: Other

Identifiers

NCT02525198

R21647

Details and patient eligibility

About

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).

Full 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).

Enrollment: 259 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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259 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo group: 12 month daily ingestion of placebo oil and flavonoid-poor matched extract

Treatment:

Dietary Supplement: Placebo

fatty acid/flavonoid blend

Experimental group

Description:

Experimental group: 12 month daily ingestion of 1.5 g EPA+DHA and 500 mg flavonoids

Treatment:

Dietary Supplement: fatty acid/flavonoid blend