Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000278437
Ethics application status
Approved
Date submitted
18/05/2007
Date registered
24/05/2007
Date last updated
24/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Older People, Omega-3, and Cognitive Health
Scientific title
An 18 month study investigating the effects of long chain omega-3 polyunsaturated fatty acids supplementation on cognition and wellbeing in older people.
Secondary ID [1] 369 0
Commonwealth Scientific Industrial Research Organisation: le51
Universal Trial Number (UTN)
Trial acronym
EPOCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
age-related cognitive decline in older adults 1818 0
Condition category
Condition code
Neurological 1909 1909 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
18 month intervention of either: ACTIVE: long chain omega-3 polyunsaturated fatty acids (430mg DHA; 150 mg EPA) Participants will consume 2 capsules in the morning and 2 in the evening for 18 months.
Intervention code [1] 1768 0
Behaviour
Comparator / control treatment
PLACEBO: Olive oil capsules
Participants will consume 2 capsules in the morning and 2 in the evening for 18 months.
Control group
Placebo

Outcomes
Primary outcome [1] 2715 0
Rate of cognitive decline
Timepoint [1] 2715 0
Participants will be assessed on a broad battery of cognitive tasks and measures of wellbeing, at 4 six-monthly intervals.
Primary outcome [2] 2716 0
Change in well being measures
Timepoint [2] 2716 0
Participants will be assessed on a broad battery of cognitive tasks and measures of wellbeing, at 4 six-monthly intervals.
Secondary outcome [1] 4583 0
Secondary outcomes are:
plasma fatty acid changes
blood pressure, oxidative stress and inflammation.
Timepoint [1] 4583 0
Markers of plasma fatty acid status, oxidative stress, systemic inflammation, and blood pressure will be assessed at each of the 4 six-monthly assessment points.

Eligibility
Key inclusion criteria
• fluency in the English language • agree to not commence own n-3 fish-oil (or algal) supplementation throughout the duration of the study
Minimum age
65 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• already taking n-3 fish-oil (or algal) supplements • inability to swallow capsules• physically unable to attend laboratory/use pen and paper • diagnosed with intellectual disability, clinical depression, dementia • score < 24 on the dementia screeening measure at screening, have had head injury, stroke, coronary artery bypass surgery, any known degenerative neurological disease, history of alcohol or drug abuse

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation concealed when it was done by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
longitudinal, 4 repeat testings at 6-monthly intervals. Participants, test administrators, and data anlayst will be blinded until after the main outcome data is analysed for an effect.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2054 0
University
Name [1] 2054 0
Brailsford Robertson Award (Adelaide University)
Country [1] 2054 0
Australia
Funding source category [2] 2055 0
Government body
Name [2] 2055 0
Commonwealth Scientific Industrial Research Organisation
Country [2] 2055 0
Australia
Funding source category [3] 243936 0
Government body
Name [3] 243936 0
National Health and Medical Research Council
Country [3] 243936 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Industrial Research Organisation
Address
PO Box 10041, Adelaide BC, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 1862 0
None
Name [1] 1862 0
n/a
Address [1] 1862 0
Country [1] 1862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3818 0
CSIRO Human Nutrition
Ethics committee address [1] 3818 0
Ethics committee country [1] 3818 0
Australia
Date submitted for ethics approval [1] 3818 0
Approval date [1] 3818 0
02/05/2007
Ethics approval number [1] 3818 0
06/19

Summary
Brief summary
Study design: a parallel 18-month randomised, double-blind, placebo-controlled intervention trial with repeated measures every 6 months, totalling 4 measurement points.
Participants: 400 men & women, aged 65-90 years.
Intervention: Half the participants will receive fish-oil capsules and the other half will receive placebo capsules for 18 months.
Outcome measures: cognitive performance and cognitive change, well-being, blood pressure, oxidative stress, and inflammation.
Demographic and nutritional data will be collected as covariates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27871 0
Address 27871 0
Country 27871 0
Phone 27871 0
Fax 27871 0
Email 27871 0
Contact person for public queries
Name 10957 0
Dr Vanessa Danthiir
Address 10957 0
CSIRO Human Nutrition
PO Box 10041 (Gate 13 Kintore Avenue)
Adelaide BC SA 5000
Country 10957 0
Australia
Phone 10957 0
+61 8 8305 0605
Fax 10957 0
+61 8 83038899
Email 10957 0
vanessa.danthiir@csiro.au
Contact person for scientific queries
Name 1885 0
Vanessa Danthiir
Address 1885 0
CSIRO Human Nutrition
PO Box 10041 (Gate 13 Kintore Avenue)
Adelaide BC SA 5000
Country 1885 0
Australia
Phone 1885 0
+61 8 83050605
Fax 1885 0
+61 8 83038899
Email 1885 0
vanessa.danthiir@csiro.au

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
EmbaseSubjective well-being in older adults: Folate and vitamin B12 independently predict positive affect.2015https://dx.doi.org/10.1017/S0007114515002949
EmbaseCross-sectional relationships of serum 25-OH-D metabolite of vitamin D with cognition and mood in a Cognitively-Healthy older cohort.2016https://dx.doi.org/10.2174/2211556005666160325202613
EmbaseAn 18-mo randomized, double-blind, placebo-controlled trial of DHA-rich fish oil to prevent age-related cognitive decline in cognitively normal older adults.2018https://dx.doi.org/10.1093/ajcn/nqx077
EmbaseThe older people, omega-3, and cognitive health (EPOCH) trial design and methodology: A randomised, double-blind, controlled trial investigating the effect of long-chain omega-3 fatty acids on cognitive ageing and wellbeing in cognitively healthy older adults.2011https://dx.doi.org/10.1186/1475-2891-10-117
N.B. These documents automatically identified may not have been verified by the study sponsor.