Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001256460
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
6/10/2025
Date registered
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12/11/2025
Date last updated
Help: Date last updated
12/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
12/11/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
Preliminary Validation of a semi-quantitative Food Frequency Questionnaire (FFQ) to Assess Omega-3 Long Chain Polyunsaturated Fatty Acid Intakes in New Zealanders.
Scientific title
Preliminary Validation of a semi-quantitative Food Frequency Questionnaire (FFQ) to Assess Omega-3 Long Chain Polyunsaturated Fatty Acid Intakes in New Zealanders.
Additional trial identifiers [1] 315517 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Omega-3 status 339108 0
Anxiety 339109 0
Depression 339299 0
Condition category
Condition code
Diet and Nutrition 335397 335397 0 0
Other diet and nutrition disorders
Mental Health 335955 335955 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
FFQ Development:
An electronic, semi-quantitative FFQ has been developed to assess usual dietary intakes of foods containing n-3 LC-PUFA over the previous three months. The New Zealand Food composition database (2024) was used to find all foods that contained n-3 LC-PUFA. Food items that are contributors to n-3 LC-PUFA intake were identified and included in the FFQ (= 0.02 g/100 g). Internet searches and visits to local supermarkets were conducted to identify products fortified with EPA and/or DHA. Included food groups are seafood, meat, eggs, dairy products, baked goods/desserts, fast foods, condiments and sauces, and n-3 fortified products. Given the varying levels of n-3 LC-PUFA within food groups, specific New Zealand fish, shellfish and meat varieties are specified in the FFQ. The FFQ includes questions about specific cuts of lamb, beef, pork, venison and chicken, as well as offal meats. Questions are also asked about whether meat products are eaten with the fat trimmed, and if chicken is consumed with or without skin. Due to the wide variety of omega-3 and fish oil supplements available, open-ended questions are used to assess their intakes and the specific brand, EPA and DHA concentrations, and dose are asked for. The frequency of consumption of foods in the FFQ range from never, to intake per month, per week and per day. Diagrams, images of a food on a standard dinner plate (Crispim, Fisberg, Marchioni, & Steluti, 2017), and quantities (g) have been used to allow study participants to visualise and more accurately estimate portion sizes. The online electronic FFQ was created in Research Electronic Data Capture (REDCap), a secure online platform for building and managing survey data and has been pilot tested in 12 adults to ensure functionality and ease of use. The n-3 LC-PUFA intakes (g/day) generated from the FFQ will be total n-3 LC-PUFA, total n-3 LC-PUFA per food grouping, and intakes of EPA, DPA, and DHA. The FFQ takes between 10 to 20 minutes to complete (based on preliminary testing in 10 adults).
Participants will complete the developed FFQ, mood questionnaires (PHQ-8 and GAD-7), weighed food records (Four days over 2 weeks) and blood spot collection at home. All questionnaires will be delivered electronically via REDCap. Once participants have provided written informed consent demographic information, and self-reported height (cm) and weight (kg) will be collected. A single drop of capillary blood (~1 mL) will be collected from each participant for the measurement of erythrocyte phospholipid n-3 LC-PUFA using dried blood spot (DBS) cards. Participants will complete the FFQ, and a 4-day weighed food record. Participants will complete the FFQ again three weeks later. Data collection will be underaken between November 2025 and February 2026.
Intervention code [1] 332139 0
Not applicable
Description of the comparator or control
Weighed Food Diary
Weighed food records (FR) are considered the ‘gold standard’ dietary assessment method as they do not rely on memory or quantity estimation. Previous research has shown that a 3-day FR was long enough to capture fatty acid intakes, however these did not specifically look at n-3 fatty acids. For the purposes of this validation study, a 4-day weighed FR has been chosen to more accurately capture dietary intakes of n-3 LC-PUFA. Subjects will be required to record their food intake for a period of four non-consecutive days, including one weekend day. Participants will do this using a pen and paper method. Dietary recording will be completed over two weeks, and recording days will be randomly assigned by the researcher. If an assigned day is impractical for the participant, an alternative day will be assigned. Having the dietary recording conducted two days per week reduces participant burden and captures potential weekly variability in dietary intakes. Each subject will be provided with an example FR and given written instructions on how to accurately measure foods and complete the FR. Participants are required to record what they ate, how much they ate and how the food was prepared. All ingredients used to make a meal will be recorded individually. If subjects are eating away from home they will be told to estimate, to the best of their ability, the weight or amounts of foods that they have consumed. The importance of maintaining normal dietary patterns and nutrition habits will be heavily emphasised, and subjects will be asked to indicate if the food recorded represented their normal dietary intake. The food diary will be returned by either email or post based on the participant’s preference. Dietary data will be analysed in Foodworks nutrient analysis software (version 10, Xyris Software) using NZ FOODfiles (2018) and Australian Food Composition Databases (AFCD, 2019).
Control group
Active

Outcomes
Primary outcome [1] 342969 0
Validity of a developed FFQ for estimating n-3 LC-PUFA intake compared with 4-day food records and erythrocyte phospholipids.
Timepoint [1] 342969 0
The FFQ is completed twice (three weeks apart). The food diary and blood samples are collected at the start of the trial with the first FFQ completion.
Secondary outcome [1] 452967 0
Total n-3 LC-PUFA concentration (%), calculated as EPA + DPA + DHA.
Timepoint [1] 452967 0
The blood samples are collected only once using Whatman blood spot cards at the beginning of the trial.
Secondary outcome [2] 452968 0
Anxiety score
Timepoint [2] 452968 0
At the beginning of the trial only once.
Secondary outcome [3] 453434 0
Depression Score
Timepoint [3] 453434 0
Measured at the beginning of the trial. only once.

Eligibility
Key inclusion criteria
18 years of age,
Must consume an omnivorous diet (i.e. consume animal proteins and vegetables),
Maintained a constant diet in the previous three months (i.e. no food restrictions or dieting regimes).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
A sample size of 50 will allow estimation of correlations as low as 0.4. In addition, this will enable estimation of differences in dietary intakes between measures to a +/- 95% precision level of 0.3 standard deviation (SD) of the difference, and estimations of Bland-Altman limits of agreement to a precision of 0.5SD. To account for potential dropout, a minimum of 60 participants will be recruited. Correlations between n-3 status and anxiety and depression will be conducted. Modelling approaches using the method of triads, Pearson’s or Spearman’s correlations, will be used. The method of triads model will be used to estimate a validity coefficient (?) for the relationship between the FFQ and an estimated “true” intake n-3 LC-PUFAs. Validity coefficients closer to 1 indicate a closer relationship between the estimated dietary score and the estimated “true” intake. For this analysis, validity coefficients between 0.2 and 0.6 will be considered moderate validity, and > 0.6 will be regarded as indicative of high validity. The inter-method agreement between the FFQ and weighed food records for the estimated n-3 LC-PUFA intake (mg/day) will be assessed using Bland-Altman plots. The mean difference (bias) and limits of agreement (defined as bias ± 1.96 SD of the mean difference) will be calculated. Test-retest reliability will also use Bland-Altman plots to assess reliability for continuous data, and kappa coefficients calculated for categorical data. Intakes of PUFAs will be described, as well as contribution of food sources to intakes. Results will be presented graphically where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2026
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
29/05/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 27419 0
New Zealand
State/province [1] 27419 0

Funding & Sponsors
Funding source category [1] 320111 0
Government body
Name [1] 320111 0
Ministry for Primary Industries
Country [1] 320111 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 322672 0
None
Name [1] 322672 0
Address [1] 322672 0
Country [1] 322672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318663 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 318663 0
Ethics committee country [1] 318663 0
New Zealand
Date submitted for ethics approval [1] 318663 0
07/07/2025
Approval date [1] 318663 0
22/09/2025
Ethics approval number [1] 318663 0
AH30043

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

Contacts
Principal investigator
Name 144850 0
A/Prof Andrea Braakhuis
Address 144850 0
University of Auckland, Faculty Medical Health Science, 85 Park Road, Grafton, Auckland, 1023
Country 144850 0
New Zealand
Phone 144850 0
+6493737599
Fax 144850 0
Email 144850 0
[email protected]
Contact person for public queries
Name 144851 0
Lillian Morton
Address 144851 0
University of Auckland, Faculty Medical Health Science, 85 Park Road, Grafton, Auckland, 1023
Country 144851 0
New Zealand
Phone 144851 0
+64 275190374
Fax 144851 0
Email 144851 0
[email protected]
Contact person for scientific queries
Name 144852 0
Dr Lillian Morton
Address 144852 0
University of Auckland, Faculty Medical Health Science, 85 Park Road, Grafton, Auckland, 1023
Country 144852 0
New Zealand
Phone 144852 0
+64 275190374
Fax 144852 0
Email 144852 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email to either [email protected] or [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.