Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000167268
Ethics application status
Approved
Date submitted
3/02/2009
Date registered
3/04/2009
Date last updated
13/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Omega-3 fatty acids and mild cognitive impairment in older adults
Scientific title
Effects of omega-3 fatty acids high in eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) vs placebo on cognition and mood in older adults with mild cognitive impairment
Secondary ID [1] 287889 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment in older adults 4265 0
Depression 296773 0
Condition category
Condition code
Mental Health 4490 4490 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 4491 4491 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six capsules containing omega-3 fatty acids plus Vitamin E, supplying a total of 360mg EPA + 1500mg DHA or 1500mg EPA + 180mg DHA per day for six months (26 weeks)
Intervention code [1] 3991 0
Treatment: Other
Comparator / control treatment
Six capsules safflower oil (placebo) capsules with Vitamin E, supplying a total of 3000mg safflower oil per day for six months (26 weeks)
Control group
Placebo

Outcomes
Primary outcome [1] 5371 0
Mean score on the Rey Auditory Verbal Learning Test (RAVLT) assessing recall and delayed recall memory
Timepoint [1] 5371 0
Baseline and 6-months
Primary outcome [2] 5372 0
Mean Geriatric Depression Scale score
Timepoint [2] 5372 0
Baseline and 6 months
Secondary outcome [1] 9028 0
Mean score on Initial and Excluded Letter Fluency
Timepoint [1] 9028 0
Baseline and 6 months
Secondary outcome [2] 9029 0
Mean score on the Trail Making Task
Timepoint [2] 9029 0
Baseline and 6 months
Secondary outcome [3] 9030 0
Mean score on Digit Span Forward and Backward
Timepoint [3] 9030 0
Baseline and 6 months
Secondary outcome [4] 9031 0
Mean score on Letter-number Sequencing
Timepoint [4] 9031 0
Baseline and 6 months
Secondary outcome [5] 9032 0
Cerebral blood vessel reactivity - transcranial Doppler sonography (tcD)
Timepoint [5] 9032 0
Baseline and 6 months
Secondary outcome [6] 9033 0
Total L-homocysteine, B12 and folate, measured from blood plasma using a Chemiluminescent Microparticle Immunoassay
Timepoint [6] 9033 0
Baseline and 6 months
Secondary outcome [7] 9034 0
Telomere length, measured by quantitative real-time polymerase chain reaction (PCR) using deoxyribonucleic acid (DNA) isolated from peripheral blood
Timepoint [7] 9034 0
Baseline and 6 months
Secondary outcome [8] 9035 0
Phospholipase A2 (PLA2) activity, assessed using high performance thin layer chromatography and quantitative imaging of resulting fluorescent spots
Timepoint [8] 9035 0
Baseline and 6 months
Secondary outcome [9] 9036 0
Mean Memory Functioning Questionnaire score
Timepoint [9] 9036 0
Baseline and 6 months
Secondary outcome [10] 241563 0
Mean score on the Stroop colour-word test
Timepoint [10] 241563 0
Baseline and 6 months
Secondary outcome [11] 241565 0
SF-36 Health Survey
Timepoint [11] 241565 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Mild cognitive impairment (subjective memory loss over past 6 months; Standardised Mini-Mental State Examination (SMMSE) score > 24; Paired Associate Learning (PAL) score < 1.5 standard deviations from population mean and/or Demtect score between 9-12)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dementia and other neurological conditions, consumption of omega-3 fatty supplements within previous 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested volunteers will undergo a telephone screening, and if they fit the criteria will be mailed an information sheet, consent form, and Diet & Lifestyle Questionnaire and booked in for a screening test using the Standardised Mini-Mental State Examination (MMSE), Demtect and PAL, and asked to fill in the Geriatric Depression Scale (GDS) short form. If eligible they will be allocated to DHA, EPA or placebo, randomised on age, gender and GDS scores by an independent researcher who has the coding sequence for preallocated supplement numbers. Allocations are concealed from investigators and participants by numbered containers, for which the treatment codes are held by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to conditions using permuted block randomisation stratified for age, gender and Geriatric Depression Scale (GDS) scores.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A healthy control group (i.e. with no cognitive impairment) will be recruited at baseline to run correlational analyses on cognition, cerebral blood flow and other biomarkers as outlined under outcome measures. Physical activity and social networks will also be assessed via questionnaires investigating their relationship with cognitive impairment and biological markers.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
18/02/2009
Date of last participant enrolment
Anticipated
Actual
14/08/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4446 0
Government body
Name [1] 4446 0
Australian Research Council (ARC) Linkage Grant
Country [1] 4446 0
Australia
Funding source category [2] 4447 0
Commercial sector/Industry
Name [2] 4447 0
Novasel Australia
Country [2] 4447 0
Australia
Primary sponsor type
University
Name
Nutritional Physiology Research Centre
Address
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 4007 0
University
Name [1] 4007 0
Australian Technology Network (ATN) Centre for Metabolic Fitness
Address [1] 4007 0
C/- Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country [1] 4007 0
Australia
Other collaborator category [1] 551 0
University
Name [1] 551 0
Queensland University of Technology
Address [1] 551 0
Institute for Health and Biomedical Innovation
60 Musk Avenue
Kelvin Grove Qld 4059
Country [1] 551 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6500 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 6500 0
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 6500 0
Australia
Date submitted for ethics approval [1] 6500 0
Approval date [1] 6500 0
09/01/2009
Ethics approval number [1] 6500 0
P141/08
Ethics committee name [2] 6501 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 6501 0
GPO Box 2434
Brisbane Qld 4001
Ethics committee country [2] 6501 0
Australia
Date submitted for ethics approval [2] 6501 0
Approval date [2] 6501 0
21/01/2009
Ethics approval number [2] 6501 0
0800000582

Summary
Brief summary
This study aims to investigate effects of omega-3 fatty acids EPA vs DHA (1500mg per day of each, supplying total omega-3 fatty acids 1860mg and 1680mg per day, respectively) versus safflower oil placebo on cognition and mood in 120 older adults with mild cognitive impairment over 6 months at two sites, in South Australia and Queensland. We will be measuring erythrocyte fatty acid levels, cerebral blood flow and blood vessel reactivity via transcranial Doppler sonography (tcD) and carbogen (5% carbon dioxide, 95% oxgen) inhalation, telomere length as an indicator of chromosomal damage, apoE-4, homocysteine, B12 and folate (the latter in collaboration with the Oxford Project to Investigate Memory and Ageing (OPTIMA) Centre for dementia research and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition). At baseline we will be doing comparisons on these outcome measures with a group of 30 healthy controls in South Australia. We are also assessing relationships between social networks, physical activity and above biomarkers, and cognitive impairment.
Trial website
Trial related presentations / publications
Publications to date:

O’Callaghan N, Parletta N, Milte CM, Benassi B, Fenech M, Petkov J, Howe PRC (2013). Telomere shortening in elderly people with mild cognitive impairment may be attenuated with omega-3 fatty acid supplementation: A randomised controlled pilot study. Nutrition, 30(4): 489-491.

Sinn N*, Milte C, Street SJ, Buckley JD, Coates AM, Petkov J, Howe PRC (2012). Effects of omega-3 fatty acids EPA versus DHA on memory and cognitive decline, depressive symptoms and quality of life in older adults with mild cognitive impairment: A 6-month randomised controlled trial. British Journal of Nutrition, 107:1284-1290

Milte C, Sinn N*, Street S, Buckley JD, Coates AM, Howe PRC (2011). Erythrocyte polyunsaturated fatty acid status, memory and cognition in older adults with mild cognitive impairment and healthy controls. Prostaglandins, Leukotrienes & Essential Fatty Acids, 84:153-161.

Presentations:

Milte CM, Parletta N, Street SJ, Coates AM, Buckley JD, Howe PRC (2012). Long chain omega-3 fatty acid supplementation improves cognition and mood in older Australians with memory problems. Oral presentation, International Society for the Study of Fatty Acids and Lipids (ISSFAL), Vancouver, Canada 26-30 May.

Sinn N, Milte CM, Street SJ, Coates AM, Buckley JD, Howe PRC (2010). Effects of omega-3 fatty acids EPA versus DHA on depressive symptoms in elderly people with mild cognitive impairment. Peer-reviewed oral presentation, Nutrition Society Australia conference, Perth, Australia, 29 Nov-3 Dec.

Sinn N, Milte CM, Street SJ, Coates AM, Buckley JD, Howe PRC (2010). Effects of omega-3 fatty acids EPA versus DHA on depressive symptoms in elderly people with mild cognitive impairment. Peer-reviewed, extended oral presentation, International Seafood and Health Conference, Melbourne 7-10 November.

Sinn N, Milte CM, Coates AM, Buckley JD, Howe PRC (2010). Erythrocyte polyunsaturated fatty acid status, memory, mood and cognition in older adults with mild cognitive impairment and healthy controls. Peer reviewed poster presentation, International Society for the Study of Fatty Acids & Lipids, 29 May-2 June, Maastricht, Belgium.

Milte C, Sinn N, Coates AM, Buckley JD, Young R, Howe PRC (2009). Erythrocyte polyunsaturated fatty acid status, memory and cognition in older adults with mild cognitive impairment and healthy controls. Peer-reviewed oral presentation, Nutrition Society Conference, Newcastle Australia, 8-11 December. Published in Conference Abstracts Nutrition Society of Australia and Nutrition Society of New Zealand 2009: III. AMJ 2010, 1, 1, 97-112 (p.103).


Street S, Sullivan K, Hills A, Sinn N, Milte C, Buckley J, Howe P (2009). Interaction of n-3 polyunsaturated fatty acids and exercise predict reduced risk of mild cognitive impairment: preliminary results. Oral presentation for the Institute of Health and Biomedical Innovation (IHI) Inspires Conference, 17-18 November, Brisbane.
Public notes

Contacts
Principal investigator
Name 29245 0
Dr Natalie Parletta
Address 29245 0
School of Population Health
University of South Australia
GPO Box 2471
Adelaide SA 5001
Australia
Country 29245 0
Australia
Phone 29245 0
+61 8 8302 1757
Fax 29245 0
Email 29245 0
[email protected]
Contact person for public queries
Name 12492 0
Dr Natalie (Sinn) Parletta
Address 12492 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 12492 0
Australia
Phone 12492 0
+61 8 8302 1757
Fax 12492 0
+61 8 8302 2178
Email 12492 0
[email protected]
Contact person for scientific queries
Name 3420 0
Dr Natalie (Sinn) Parletta
Address 3420 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 3420 0
Australia
Phone 3420 0
+61 8 8302 1757
Fax 3420 0
+61 8 8302 2178
Email 3420 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AITelomere shortening in elderly individuals with mild cognitive impairment may be attenuated with ?-3 fatty acid supplementation: A randomized controlled pilot study2013https://doi.org/10.1016/j.nut.2013.09.013
N.B. These documents automatically identified may not have been verified by the study sponsor.