Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000572066
Ethics application status
Approved
Date submitted
12/07/2010
Date registered
16/07/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a dietary intervention designed to optimise nutritional status in women of child-bearing age
Scientific title
The effects of health related bio-markers in healthy women of child-bearing age consuming a diet higher in fish when compared to those who consumed a typical Australian diet higher in meat
Secondary ID [1] 252156 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long chain n-3 fatty acids intake and status 257696 0
Mercury intake and status 257697 0
Iron intake and status 257699 0
Condition category
Condition code
Diet and Nutrition 257871 257871 0 0
Other diet and nutrition disorders
Cardiovascular 257908 257908 0 0
Normal development and function of the cardiovascular system
Reproductive Health and Childbirth 257909 257909 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A diet higher in fish. Participants will substitute their usual meat meals with study food provided on four occasions each week. Study food comprises of a variety of Australian fish and fish products (raw and processed) and provides at least 200mg per day of docosahexanoic acid (DHA) on average. Participants will be advised to maintain their usual diet throughout the study period except for the four replacement meals and to avoid foods that are high in omega-3 fatty acids. Duration of intervention is 8 weeks with a 2-week run-in period.
Intervention code [1] 256754 0
Prevention
Intervention code [2] 256797 0
Lifestyle
Comparator / control treatment
A typical Australian diet higher in meat. Participants will substitute their usual meat meals with study food provided on four occasions each week. Study food comprises of a variety of raw and processed meat products which are matched as closely as feasible in energy, fat, protein and salt contents to the intervention study food. Participants will be advised to maintain their usual diet throughout the study period except for the four replacement meals and to avoid foods that are high in omega-3 fatty acids. Duration of the study is 8 weeks with a 2-week run-in period.
Control group
Active

Outcomes
Primary outcome [1] 258730 0
Long chain n-3 fatty acids levels in blood
Timepoint [1] 258730 0
At baseline and at 8 weeks after randomisation
Primary outcome [2] 258731 0
Mercury and methyl mercury levels in blood
Timepoint [2] 258731 0
At baseline and at 4 and 8 weeks after randomisation
Primary outcome [3] 258732 0
Iron status (iron, ferritin, transferrin and haemoglobin in blood)
Timepoint [3] 258732 0
At baseline and at 8 weeks after randomisation
Secondary outcome [1] 264771 0
Cardiovascular risk factors (Blood pressure using an automatic sphygmomanometer; total cholesterol, high-density lipoprotein, low-density lipoprotein and triglycerides by blood analysis)
Timepoint [1] 264771 0
At baseline and at 8 weeks after randomisation
Secondary outcome [2] 264772 0
Inflammatory markers (C-Reactive Protein [CRP], tumor necrosis factor-alpha [TNF-alpha], interleukin 1-beta [IL-1 beta] and interleukin 6 [IL-6] by blood analysis)
Timepoint [2] 264772 0
At baseline and at 8 weeks after randomisation
Secondary outcome [3] 264773 0
Selenium level in blood
Timepoint [3] 264773 0
At baseline and at 8 weeks after randomisation
Secondary outcome [4] 264774 0
Single-nucleotide polymorphisms of key genes associated with lipid, n-3 fatty acids and mercury metabolism by blood analysis
Timepoint [4] 264774 0
At baseline
Secondary outcome [5] 264775 0
Mean Center for Epidemiologic Studies Depression score
Timepoint [5] 264775 0
At baseline and at 8 weeks after randomisation
Secondary outcome [6] 264776 0
Body Mass Index
Timepoint [6] 264776 0
At baseline and at 8 weeks after randomisation
Secondary outcome [7] 264777 0
Body composition by dual energy x-ray absorptiometry (DXA)
Timepoint [7] 264777 0
At baseline and at 8 weeks after randomisation
Secondary outcome [8] 264778 0
Diet acceptability using a diet acceptability questionnaire
Timepoint [8] 264778 0
At 8 weeks after randomisation

Eligibility
Key inclusion criteria
Healthy women volunteers 18-50 years of age who are not pregnant and not trying to become pregnant for the duration of the study

Body Mass Index [BMI] >=18.5 to <30 kg/m2 and relatively stable in body weight over the last 3 months (less than +/- 5% of body weight change)

Provides written informed consent

Willing to comply to study procedures
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male;
>50 years of age;
Currently pregnant or trying to become pregnant, lactating, perimenopausal or postmenopausal;
BMI< 18.5 or >=30 kg/m2 or high variation in body weight over the last 3 months (+/- 5% or more of body weight change) or has intention to modify weight status during the study period;
Daily consumer of fish oil or other supplements which could interfere with lipid metabolism;
Bleeding disorder;
Type 1 or type 2 diabetes (fasting blood glucose >=7mmol/L);
Cardiovascular disease (e.g. unstable angina, heart failure, hypertension {systolic blood pressure [SBP] >140 mmHg or diastolic blood pressure [DBP] >90 mmHg, average of two readings});
Dyslipidaemia (total cholesterol > 5.5 mmol/L or triglyceride > 2 mmol/L);
Chronic inflammatory disease (e.g. rheumatoid arthritis, Crohn’s Disease, ulcerative colitis);
Taking any medication or suffering from any condition that is incompatible with the study (e.g. regular users of non-steroidal anti-inflammatory drugs);
Seafood allergy;
Vegetarian or vegan;
Irregular physical activity pattern during study period;
Usual diet includes more than one fatty fish meal per week on average;
Women working in occupations with regular exposure to mercury

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 will be concealed by the use of sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a computer programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257247 0
Other
Name [1] 257247 0
Australian Seafood Cooperative Research Centre (CRC) Company Limited
Country [1] 257247 0
Australia
Primary sponsor type
Individual
Name
Lynne Cobiac
Address
Nutrition and Dietetics
GPO Box 2100 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 256490 0
None
Name [1] 256490 0
Address [1] 256490 0
Country [1] 256490 0
Other collaborator category [1] 251366 0
Individual
Name [1] 251366 0
Campbell Thompson
Address [1] 251366 0
Discipline of Medicine
University of Adelaide
North Terrace, SA 5005
Country [1] 251366 0
Australia
Other collaborator category [2] 251367 0
Individual
Name [2] 251367 0
Jocelyn Midgley
Address [2] 251367 0
2 Chifley Drive
Mentone, VIC 3195
Country [2] 251367 0
Australia
Other collaborator category [3] 251368 0
Individual
Name [3] 251368 0
Michelle Miller
Address [3] 251368 0
Nutrition and Dietetics
Flinders University
GPO Box 2100 Adelaide SA 5001
Country [3] 251368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259266 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 259266 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 259266 0
Australia
Date submitted for ethics approval [1] 259266 0
Approval date [1] 259266 0
08/06/2010
Ethics approval number [1] 259266 0
83/10

Summary
Brief summary
Studies have shown that adequate maternal docosahexanoic acid (DHA) intake during pregnancy is an important factor for optimal development of the foetus. Fish is a good source of DHA, however, its intake in Australian women is generally low and well below recommendation. This 8-week study aims to determine if a diet higher in fish (providing an average of at least 200mg of DHA/day) obtained from consuming Australian fish 4 times a week can improve health-related bio-makers and outcomes (e.g. erythrocytes membrane n-3 concentrations, lipids, inflammatory markers, depression score) without compromising iron nutriture when compared to a typical Australian diet that is generally low in fish and higher in meat. This study will also predict the blood level of mercury if the higher fish dietary pattern was to be maintained long term.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31364 0
Address 31364 0
Country 31364 0
Phone 31364 0
Fax 31364 0
Email 31364 0
Contact person for public queries
Name 14611 0
Lily Chan
Address 14611 0
Nutrition and Dietetics
Flinders University
GPO Box 2100 Adelaide SA 5001
Country 14611 0
Australia
Phone 14611 0
+61 8 82047077
Fax 14611 0
+61 8 82046406
Email 14611 0
[email protected]
Contact person for scientific queries
Name 5539 0
Lynne Cobiac
Address 5539 0
Nutrition and Dietetics
Flinders University
GPO Box 2100 Adelaide SA 5001
Country 5539 0
Australia
Phone 5539 0
+61 8 82047068
Fax 5539 0
+61 8 82046406
Email 5539 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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