Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001694202
Ethics application status
Approved
Date submitted
9/10/2018
Date registered
15/10/2018
Date last updated
22/01/2020
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
22/01/2020
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
Yes
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
Treatment
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/10/2018
Actual
24/10/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
1/07/2019
Date of last data collection
Anticipated
31/05/2019
Actual
1/08/2019
Sample size
Target
16
Accrual to date
Final
13
Recruitment outside Australia
Country [1] 20911 0
New Zealand
State/province [1] 20911 0
Auckland

Funding & Sponsors
Funding source category [1] 300886 0
Other
Name [1] 300886 0
Riddet Centre of Research Excellence
Country [1] 300886 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country
New Zealand
Secondary sponsor category [1] 300450 0
None
Name [1] 300450 0
Address [1] 300450 0
Country [1] 300450 0

Ethics approval
Ethics application status
Approved
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
4442
Ethics committee country [1] 301659 0
New Zealand
Date submitted for ethics approval [1] 301659 0
27/08/2018
Approval date [1] 301659 0
17/09/2018
Ethics approval number [1] 301659 0
Southern A, Application SOA 18/53

Summary
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

Contacts
Principal investigator
Name 87694 0
Dr Noha Nasef
Address 87694 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 87694 0
New Zealand
Phone 87694 0
+64 69519421
Fax 87694 0
Email 87694 0
[email protected]
Contact person for public queries
Name 87695 0
Dr Noha Nasef
Address 87695 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 87695 0
New Zealand
Phone 87695 0
+64 69519421
Fax 87695 0
Email 87695 0
[email protected]
Contact person for scientific queries
Name 87696 0
Dr Noha Nasef
Address 87696 0
Riddet Institute
Massey University
Tennent drive
Palmerston North
New Zealand
4442
Country 87696 0
New Zealand
Phone 87696 0
+64 69519421
Fax 87696 0
Email 87696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by ethics


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.