Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12624000711516
Ethics application status
Approved
Date submitted
24/05/2024
Date registered
7/06/2024
Date last updated
7/06/2024
Date data sharing statement initially provided
7/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Omega-3 indices following chia and flax seed comsumption in populations following a low fat, wholefood, plant-based dietary pattern
Scientific title
Omega-3 indices in healthy adult populations following low fat, wholefood, plant-based dietary patterns following consumption of chia and flax seeds high in alpha-linolenic acid.
Secondary ID [1] 312221 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Omega-3 deficiency 333903 0
Condition category
Condition code
Diet and Nutrition 330581 330581 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Flax and chia seeds (22.5 grams of flax seeds and 22.5 grams of chia seeds containing ~10.25 grams of ALA) in a population following a whole food plant-based diet.

The flax and chia seeds will be incorporated daily (45g/day) into participants existing diets by mixing or adding to meals i.e. sprinkled on oats for 8 weeks.

Adherence will be monitored by asking participants to return all seeds which were not consumed during the 8 week intervention.

Both groups will be asked to continue eating their existing low fat (<20%) whole food plant-based diets. Additionally, both groups will also complete a validated online 24 hour diet recall to measure adherence to the intervention.
Intervention code [1] 328668 0
Treatment: Other
Comparator / control treatment
Continued habitual diet (no seed intervention in a population following a whole food plant-based diet)
Control group
Active

Outcomes
Primary outcome [1] 338335 0
Omega-3 index
Timepoint [1] 338335 0
Baseline and at 8 weeks post-baseline
Secondary outcome [1] 435468 0
alpha-linolenic acid
Timepoint [1] 435468 0
Baseline and at 8 weeks post-baseline
Secondary outcome [2] 435469 0
omega-6 fatty acids
Timepoint [2] 435469 0
Baseline and at 8 weeks post-baseline
Secondary outcome [3] 435470 0
Eicosapentaenoic acid
Timepoint [3] 435470 0
Baseline and at 8 weeks post-baseline
Secondary outcome [4] 435471 0
Docosahexaenoic acid
Timepoint [4] 435471 0
Baseline and at 8 weeks post-baseline
Secondary outcome [5] 435473 0
Anthropometry (Weight, height)
Timepoint [5] 435473 0
Baseline and at 8 weeks post-baseline

Eligibility
Key inclusion criteria
• 18-years-old or older
• Habitual dietary intake of a whole food, plant-based (WFPB) low fat (<20%) diet > 6 months (Validated with a food frequency questionnaire (FFQ))
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Moderate or high fat diet ( greater than 20% of total energy intake)
• Dairy or meat intake
• Currently consuming or consumed omega-3 supplements including algal supplements in past 3 months.
* Greater than 10 grams of chia, flax, or hemp seeds consumed daily
• Flaxseed or chia seed allergy

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)
Random number generator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
5/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316599 0
Other
Name [1] 316599 0
Consultancy fund from retired professor left to nutrition and dietetics staff from the University of Wollongong to conduct research
Country [1] 316599 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 318782 0
None
Name [1] 318782 0
Address [1] 318782 0
Country [1] 318782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315382 0
University of Wollongong Human Ethics Research Commitee
Ethics committee address [1] 315382 0
Ethics committee country [1] 315382 0
Australia
Date submitted for ethics approval [1] 315382 0
11/02/2024
Approval date [1] 315382 0
10/04/2024
Ethics approval number [1] 315382 0

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

Contacts
Principal investigator
Name 134530 0
Dr Joel Craddock
Address 134530 0
The University of WOllongong, Northfields Ave, Wollongong, NSW, 2500
Country 134530 0
Australia
Phone 134530 0
+61 2 4221 4208
Fax 134530 0
Email 134530 0
jcraddock@uow.edu.au
Contact person for public queries
Name 134531 0
Joel Craddock
Address 134531 0
The University of WOllongong, Northfields Ave, Wollongong, NSW, 2500
Country 134531 0
Australia
Phone 134531 0
+61 02 42213555
Fax 134531 0
Email 134531 0
jcraddock@uow.edu.au
Contact person for scientific queries
Name 134532 0
Joel Craddock
Address 134532 0
The University of WOllongong, Northfields Ave, Wollongong, NSW 2500
Country 134532 0
Australia
Phone 134532 0
+61 02 42213555
Fax 134532 0
Email 134532 0
jcraddock@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.