Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000336482p
Ethics application status
Not yet submitted
Date submitted
2/04/2025
Date registered
22/04/2025
Date last updated
22/04/2025
Date data sharing statement initially provided
22/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Mussels as a snack option to increase the omega-3 index and markers of recovery in female endurance athletes
Scientific title
The Effect of Mussel Consumption on Omega-3 Index and Recovery Markers in Female Endurance Athletes
Secondary ID [1] 314109 0
Nill known
Universal Trial Number (UTN)
Trial acronym
The Mussels Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrient Deficiency 336902 0
Post-exercise recovery 337024 0
Condition category
Condition code
Diet and Nutrition 333370 333370 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of two study arms. Those in the intervention group (Mussel snack group) will consume 90 grams of cooked, vacuum-packed blue mussels as a snack on five non-consecutive days per week for 12 weeks. Mussels will be provided in pre-portioned, food-safe packaging and stored in dedicated food-only refrigerators. Participants will be given safe storage instructions and simple preparation ideas to support adherence, but no specific cooking method is required. Mussels are provided as a whole food source rich in omega-3 fatty acids, protein, iron, and other key micronutrients. All participants will maintain their usual diet and training routine. Adherence will be monitored through daily self-reported tallies via REDCap and biweekly food records using the Easy Diet Diary app. Both groups will undergo baseline and post-intervention testing at Deakin University (Burwood or Waurn Ponds), including DEXA body composition scans, venous blood sampling at Dorevitch Pathology, and finger-prick blood tests. The intervention is not personalised or titrated, and all data collection and support will be managed by trained research staff, including an Accredited Practising Dietitian (APD).
Intervention code [1] 330682 0
Treatment: Other
Comparator / control treatment
The control group (Nut snack group) will consume an isocaloric portion of mixed nuts (approximately 90g) as a snack five times per week for 12 weeks. Nuts will be provided in pre-portioned packs, with participants instructed to maintain their usual diet and training. The control group follows the same procedures and assessment schedule as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 340940 0
Any change in omega-3 index in apparently healthy female endurance athletes consuming mussels compared to an isocaloric nut-based control.
Timepoint [1] 340940 0
Baseline (Week 0) and Post-intervention completion (Week 12).
Secondary outcome [1] 445539 0
Any change in vitamin D levels in apparently healthy female endurance athletes consuming mussels compared to an isocaloric nut-based control.
Timepoint [1] 445539 0
Baseline (Week 0) and Post-intervention completion (Week 12).
Secondary outcome [2] 445540 0
Any change in iron status (including ferritin, haemoglobin, and transferrin saturation) in a mussel-consumption group compared to the nut-based controll. (This is a composite secondary outcome)
Timepoint [2] 445540 0
Baseline (Week 0) and Post-intervention completion (Week 12).
Secondary outcome [3] 445541 0
Any change in post-exercise recovery in apparently healthy female endurance athletes consuming mussels compared to an isocaloric nut-based control.
Timepoint [3] 445541 0
Daily throughout the 12-week intervention.

Eligibility
Key inclusion criteria
Participants must be 1) female adults ( aged between 18-50 years), 2) with a training history of two years or more (specific to cycling, running, triathlon), 3) currently completing endurance-based training more than two times per week or with an average exercise training duration of more than 5 hours per week, 4) healthy and free of injury and, 5) eumenorrheic (experiencing regular natural menstrual cycles 21-35 days in length) or stable use of hormonal contraceptives for at least three months before testing. 6) Participants must live in Victoria, Australia, and be willing to travel to either Deakin Geelong or Burwood Campus on six occasions and a nearby Dorevitch Pathology on two separate occasions.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they 1) self-report as vegetarian or vegan; 2) allergy to nuts or shellfish or 3) are regular consumers of shellfish/oily fish ( more than once per week over the past 3 months); 4) currently participating in a weight loss program or special diet (ketogenic, low carb or similar); 5) smokers; 6) BMI higher than 29.9 kg/m2; 7) acute or terminal illness; 8) with a current injury or functional impairment that would limit inclusion in the trial; 9) use of supplements (vitamin D, omega-3) or medication known to affect iron status; 10) current chronic disease including cancer, diabetes, cardiovascular disease, chronic liver disease, and gastrointestinal disorders that affects nutrient absorption; 11) cognitive impairment; or inability to commit to the study and its requirements and be randomised to their experimental group. These criteria minimise confounding influences on omega-3 status, iron levels, and recovery markers while ensuring participant safety and study validity.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
1/05/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318615 0
Commercial sector/Industry
Name [1] 318615 0
Fisheries Research and Development Corporation (FRDC)
Country [1] 318615 0
Australia
Funding source category [2] 318758 0
Commercial sector/Industry
Name [2] 318758 0
Yumbah Mussels Holdings PTY
Country [2] 318758 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 321021 0
None
Name [1] 321021 0
Address [1] 321021 0
Country [1] 321021 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317219 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 317219 0
Ethics committee country [1] 317219 0
Australia
Date submitted for ethics approval [1] 317219 0
23/04/2025
Approval date [1] 317219 0
Ethics approval number [1] 317219 0

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

Contacts
Principal investigator
Name 140386 0
Dr David Lee Hamilton
Address 140386 0
Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 140386 0
Australia
Phone 140386 0
+61 392445207
Fax 140386 0
Email 140386 0
[email protected]
Contact person for public queries
Name 140387 0
David Lee Hamilton
Address 140387 0
Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 140387 0
Australia
Phone 140387 0
+61 392445207
Fax 140387 0
Email 140387 0
[email protected]
Contact person for scientific queries
Name 140388 0
David Lee Hamilton
Address 140388 0
Geelong Waurn Ponds Campus, 75 Pigdons Road, Waurn Ponds, VIC 3216
Country 140388 0
Australia
Phone 140388 0
+61 392445207
Fax 140388 0
Email 140388 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Due to the Industry Partnership in place and to guarantee confidentiality of the participants, individual participants data for this trial won't be available.
This data is part of a pilot test and won't be considered for sharing at the time.
If this changes, it will be updated in the registry.



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.