Investigating the effects of a high DHA fish oil supplement on cognitive performance in older adults with Mild Cognitive Impairment: A 12-month randomised, double-blind, placebo controlled trial based in Wellington, New Zealand

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Neurological - Dementias; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12614000874617
• Lead Sponsor: Alexia Mengelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Inclusion criteria for participants will be a diagnosis of cognitive impairment based on neuropsychological assessment and self-reporting. Agree to not start taking own fish oil supplement during the 12-month trial.
.

Exclusion Criteria

Major medical conditions including head injury or recent major surgery, problem swallowing capsules, consumption of 3 more more servings of oily fish per week, consumption of fish oil supplements in the last 12 months and an allergy to fish or seafood.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of cognitive improvement or decline using the following battery of tests:: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Californina Older Adult Stroop Test (COAST), the Coin Rotation Task (CRT), the Trail Making Test A and B (TMT), the National Adult Reading Test (NART) and the Digit Span backwards test (DSBT) from the Weschler Adult Intelligence Scale 3 (WAIS-III).[Participants will be tested on the cognitive tests at baseline, after 6 and 9 months of taking the supplements and lastly a final testing session after 12-months at end of the trial.];Change in well-being measures: Geriatric Depression Scale (GDS) SF-36 Short Form 36 and the Geriatric Anxiety Inventory (GAI).[Participants will be tested on the cognitive tests at baseline, after 6 and 9 months of taking the supplements and lastly a final testing session after 12-months at end of the trial.]

Secondary Outcome Measures

Name	Time	Method
Changes in weight. Tested using a digital scale. [Baseline testing session and at the final testing session after 12-months at the end of the trial.];Blood pressure. Tested using a digital sphygmomanometer.[Baseline testing session and at the final testing session after 12-months at the end of the trial.];Presence or absence of APOE 4 gene by way of a blood sample using polymerase chain reaction analysis.[At the final testing session after 12-months at the end of the trial.]