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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
uow-humanethics@uow.edu.au
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
This intervention study is designed to assess and quantify the effect of flax and chia seeds, which are high in alpha-linolenic acid (ALA) which can theoretically be converted into the long chain omega 3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The population will be those habitually following a low fat, whole food plant-based diet. This population has been selected as they have a low total, and omega-6 fat intake, which can compete with ALA for conversion to DHA and EPA.

The proposed study will consist of a randomised controlled intervention for 8 weeks in a population following a low fat (<20% of total energy intake) whole food plant-based diet including:
1) Flax and chia seeds (22.5 grams of flax seeds and 22.5 grams of chia seeds containing ~10.25 grams of ALA + habitual low fat whole food plant-based diet Or 2) Continued habitual low fat whole food plant-based diet. It is hypothesied that the chia/flax intervention will not induce a significant difference in omega-3 indices
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.