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
As we get older, it is difficult to eat the right amount of food and get the right nutrients every day. When we do not get enough nutrients in our diet, this can sometimes lead to various diseases or conditions. Fish and seafood provide some valuable nutrients including protein, zinc, iodine and vitamin D. In particular, fish and seafood also contain fatty acids (called EPA and DHA) which may reduce the amount of inflammation in your body. Meat products also contain protein, zinc, iron, some B vitamins and fatty acids. Most people eat more red meat compared to fish and we do not know much about how this affects inflammation. You can’t see inflammation, but higher levels have been associated with arthritis, diabetes, eye diseases, heart disease, depression and even obesity. We are interested in reducing these levels of inflammation in the body because this may reduce the risk for these diseases. Many people do not eat a lot of fish, and so we want to find out whether increasing the amount of fish/seafood in our diet (to approximately 4 meals per week) will help levels of inflammation compared to people who eat a usual amount of fish/seafood (0-1 meal of fish/seafood a week) and eat a diet that is higher in red meat.
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.