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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of salmon on metabolic and inflammatory markers in healthy women
Scientific title
Measuring postprandial inflammatory and metabolic markers in blood to assess the health impact of salmon in healthy female participants after a fatty meal
Secondary ID [1] 296294 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fat metabolism 309974 0
Condition category
Condition code
Metabolic and Endocrine 308746 308746 0 0
Normal metabolism and endocrine development and function

Study type
Description of intervention(s) / exposure
The 16 participants will attend in groups of 1-3. Each participant will be invited to attend 3 study visits with a washout period of ~7 days. In each of the study visits, participants will arrive at the research unit in Massey university, Auckland. They will be given a meal containing potatoes and 40g of fat from cream, Each meal will also contain ~120g of intact salmon, homogenized salmon or salmon oil plus deffatted salmon.

Participants will be asked to finish the meal within 15 minutes and adherence monitored via direct supervision.

The meals will be matched for moisture. All meals contain around 550 kcals (foodworks 9, 2016 NZ food files).

A cannula will be inserted into the forearm of the participant and blood will be taken before the meal is consumed or 30 minutes, 1, 2, 3, 4 and 6 hours after the meal is consumed.
Intervention code [1] 312623 0
Treatment: Other
Comparator / control treatment
Intact salmon meal
Control group

Primary outcome [1] 307731 0
Measure the bioavailabilty of omega- 3 in the blood (using Cmax and AUC)
Timepoint [1] 307731 0
0 hours, 30 minutes and 1, 2,3, 4 and 6 hours post meal (primary endpoint)
Secondary outcome [1] 352685 0
Measure blood triglyceride level (using Cmax and AUC)
Timepoint [1] 352685 0
0 hours, 30 minutes and 1, 2, 3,4 and 6 hours post meal

Key inclusion criteria
A healthy female aged between 18 and 45 years, with a regular menstrual cycle and a normal body weight (body mass index between 18 and 30 kg/m2) at initial assessment.
Minimum age
18 Years
Maximum age
45 Years
Can healthy volunteers participate?
Key exclusion criteria
• Are pregnant or trying to get pregnant (during the study period)
• Suffer from cancer, HIV/Aids or inflammatory bowel disease
• Think you have a weak immune system
• Use herbal supplements or fish oil regularly
• Take immunosuppressive drugs
• Recently donated blood or have a fear of needles
• Smoke
• Take any lipid lowering drugs or supplements or hypertensive drugs
• Are dieting or have any eating disorders
• Have a dislike, intolerance or allergy to dairy and/or fish
• Have a history of heart disease
• Have a history of diabetes, hypertension, high cholesterol
• Have a history of gastrointestinal disorder or liver disease
• Vigorously active

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which the meals will be given to participants will be determined using 3 pre-generated unique sequences. Each participant will be randomly allocated to one of the 4 sequences using simple randomization generated from a calculator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 20911 0
New Zealand
State/province [1] 20911 0

Funding & Sponsors
Funding source category [1] 300886 0
Name [1] 300886 0
Riddet Centre of Research Excellence
Address [1] 300886 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
Country [1] 300886 0
New Zealand
Primary sponsor type
Massey University
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
New Zealand
Secondary sponsor category [1] 300450 0
Name [1] 300450 0
Address [1] 300450 0
Country [1] 300450 0

Ethics approval
Ethics application status
Ethics committee name [1] 301659 0
Massey University Human Ethics Committee
Ethics committee address [1] 301659 0
Massey University
Tennent drive
Palmerston North
New Zealand
Ethics committee country [1] 301659 0
New Zealand
Date submitted for ethics approval [1] 301659 0
Approval date [1] 301659 0
Ethics approval number [1] 301659 0
Southern A, Application SOA 18/53

Brief summary

The main aim of this study is to investigate if salmon structure is important in fat metabolism. To test this we will be undertaking a single meal crossover study in healthy female participants and fat-induced blood markers measured.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 87694 0
Dr Noha Nasef
Address 87694 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
Country 87694 0
New Zealand
Phone 87694 0
+64 69519421
Fax 87694 0
Email 87694 0
Contact person for public queries
Name 87695 0
Dr Noha Nasef
Address 87695 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
Country 87695 0
New Zealand
Phone 87695 0
+64 69519421
Fax 87695 0
Email 87695 0
Contact person for scientific queries
Name 87696 0
Dr Noha Nasef
Address 87696 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
Country 87696 0
New Zealand
Phone 87696 0
+64 69519421
Fax 87696 0
Email 87696 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Not approved by ethics
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary