None listed
Conditions
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). In addition, a group of 20 healthy control participants were studied at baseline only to allow researchers to explore hippocampal integrity within the continuum of cognitive decline from healthy, to subjective memory impairment, to mild cognitive impairment.
Interventions
Fatty acid/flavonoid blend.
Daily (for 12 months) ingestion of study product containing 1.5g EPA + DHA, and 550mg of cocoa flavanols, provided as a cocoa extract. Compliance will be monitored using daily study food logs completed by the participant after taking their study treatments, along with counting the number of returned treatments at each study session.
A sub-group of 20 participants were not administered any intervention (active or placebo) and completed only the baseline measures, inc
Fatty acid/flavonoid blend. Daily (for 12 months) ingestion of study product containing 1.5g EPA + DHA, and 550mg of cocoa flavanols, provided as a cocoa extract. Compliance will be monitored using daily study food logs completed by the participant after taking their study treatments, along with counting the number of returned treatments at each study session. A sub-group of 20 participants were not administered any intervention (active or placebo) and completed only the baseline measures, including neuroimaging measures. These participants were healthy controls with no memory complaints or cognitive impairment.
Sponsors
Swinburne Univeristy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For main study: Male and female, aged 55 years and over 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 For healthy controls sub-study: The same inclusion criteria apply except that participants must not have MCI or SMI
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
Outcome results
None listed