Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000619943
Ethics application status
Approved
Date submitted
16/06/2011
Date registered
16/06/2011
Date last updated
5/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inflammatory changes following a dietary intervention in the elderly.
Scientific title
Effects of a high seafood diet on markers of inflammation in a group of Australian men and women over 64 years of age.
Secondary ID [1] 253581 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 261142 0
Condition category
Condition code
Inflammatory and Immune System 259298 259298 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an 8 week study. For the duration of the study, one group will be randomized to a fish group in which they will receive 3-4 serves of fish per week that contains various amounts of long chain omega 3 fatty acids to reach a target level of ~800 mg/day EPA + DHA.
Intervention code [1] 257820 0
Lifestyle
Comparator / control treatment
The control group will consume their usual diet for the duration of the study, that includes 3-4 serves of red meat (including pork) per week.
Control group
Active

Outcomes
Primary outcome [1] 259912 0
Plasma CRP
Timepoint [1] 259912 0
Baseline and end of study (ie. week 0 and week 8)
Primary outcome [2] 259913 0
Red blood cell fatty acids
Timepoint [2] 259913 0
Baseline and end of study (ie. week 0 and week 8)
Secondary outcome [1] 268806 0
Clinical: Blood pressure, plasma lipids (TC, Triglycerides, HDL-C, LDL-C, glucose)
Timepoint [1] 268806 0
Baseline and end of study (ie. week 0 and week 8)
Secondary outcome [2] 268807 0
Centre for Epidemiologic Studies-Depression Scale
Timepoint [2] 268807 0
Baseline and end of study (ie. week 0 and week 8)
Secondary outcome [3] 268808 0
Inflammatory markers/cytokines: Plasma IL-6, IL-1, TNF-alpha, ICAM-1, VCAM-1, E-selectin
Timepoint [3] 268808 0
Baseline and end of study (ie. week 0 and week 8)
Secondary outcome [4] 268809 0
Body composition: DXA
Timepoint [4] 268809 0
Baseline and end of study (ie. week 0 and week 8)

Eligibility
Key inclusion criteria
- Men and women >64 years old
- Fish/seafood intake <1 serving of fish/week
- Willing to consume ~4 servings of provided fish/seafood per week OR red meat per week
- Ability to provide written informed consent
- Able to attend clinic visits at Flinders Medical Centre
Minimum age
64 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to comply with study protocol
- Allergies to seafood
- Vegetarian
- Intake of vitamin and mineral supplements within the past 3 weeks of clinic screening
- Intake of lipid-lowering supplements (eg. psyllium, fish oil capsules, soy lecithin, phytoestrogens)
- Intake of anti-inflammatory medications on a regular basis or if an acute intake, within 1 week of clinic screening visit
- On warfarin medication
- Presence of diabetes, liver, kidney, thyroid (unless controlled and stable on replacement medication)
- Presence of other endocrine disorders from self-reported medical history
- Weight loss or gain of 10% body weight or more during a period of 6 months before screening visit
- Clinically diagnosed depression or dementia.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be block randomised to follow either a higher fish diet (intervention) or a typical Australian diet that is low in fish and higher in meat (control).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258474 0
Commercial sector/Industry
Name [1] 258474 0
Australian Seafood Cooperative Research Centre
Country [1] 258474 0
Australia
Funding source category [2] 258475 0
University
Name [2] 258475 0
Flinders University
Country [2] 258475 0
Australia
Primary sponsor type
Individual
Name
Jessica Grieger
Address
Level 7-E, Nutrition and Dietetics, Flinders Medical Centre
Flinders Drive, BEDFORD PARK,  SA  5042
Country
Australia
Secondary sponsor category [1] 257615 0
None
Name [1] 257615 0
Address [1] 257615 0
Country [1] 257615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260451 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 260451 0
Ethics committee country [1] 260451 0
Australia
Date submitted for ethics approval [1] 260451 0
Approval date [1] 260451 0
04/02/2011
Ethics approval number [1] 260451 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32071 0
Address 32071 0
Country 32071 0
Phone 32071 0
Fax 32071 0
Email 32071 0
Contact person for public queries
Name 15318 0
Jessica Grieger
Address 15318 0
Nutrition and Dietetics
Level 7E-107, Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 15318 0
Australia
Phone 15318 0
+61 8 8204 7075
Fax 15318 0
Email 15318 0
jessica.grieger@flinders.edu.au
Contact person for scientific queries
Name 6246 0
Jessica Grieger
Address 6246 0
Nutrition and Dietetics
Level 7E-107, Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Country 6246 0
Australia
Phone 6246 0
+61 8 8204 7075
Fax 6246 0
Email 6246 0
jessica.grieger@flinders.edu.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
No additional documents have been identified.