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This study evaluates the effect of a fatty acid/flavonoid blend supplement, compared with placebo, in older adults with mild cognitive impairment or subjective memory complaints. People aged 55 and over with mild cognitive impairment or subjective memory impairment but no dementia or depression may take part. It was carried out as a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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