Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000836932
Ethics application status
Approved
Date submitted
18/06/2020
Date registered
24/08/2020
Date last updated
14/09/2021
Date data sharing statement initially provided
24/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate the plasma absorption of 4 (four) EPA/DHA formulations on increasing
Omega-3 fatty acid concentration in healthy participants over an 8-week period.
Scientific title
A study to evaluate the plasma absorption of 4 (four) EPA/DHA formulations on increasing
Omega-3 fatty acid concentration in healthy participants over an 8-week period.
Secondary ID [1] 301537 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LTFISH-20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood absorption of Omega 3 fatty acid 317898 0
Condition category
Condition code
Alternative and Complementary Medicine 315935 315935 0 0
Other alternative and complementary medicine
Metabolic and Endocrine 316379 316379 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to compare the effect of 4 (four) Eicosapentaenoic acid
(EPA)/Docosahexaenoic acid (DHA) formulations at different doses on increasing omega-3 fatty acid concentrations in healthy participants over an 8-week period. The first formulation is standard EPA/DHA oil from Fish and the second formulation is EPA/DHA from Krill. For the final 2 formulations it will be the same oil Fish or Krill oil with added AquaCelle.

Approximately 80 (20 per group) otherwise healthy adult male or female participants, aged over 18 will be recruited. Following preliminary screening via telephone, potential participants will
attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, physical assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be allocated to one of four groups (total n=80). Both participants and investigators will be blinded to the make-up of the treatment. Participants will take the allocated investigational product daily for a period of 8 weeks. Additional fasting blood samples will be taken at 2,4,6 and 8 weeks. Participants will be advised to avoid omega-3 containing products for the entire study duration. Participants will be monitored for compliance with the protocol by a combination of telephone and email communications.

The investigational product:

Standard fish oil 800 mg (1 capsule providing approximately 500 mg EPA+DHA)
Fish oil 800 mg with AquaCelle (1 capsule providing approximately 500 mg EPA+DHA)
Krill Oil 750 mg (2 capsules providing approximately 180 mg EPA+DHA)
Krill Oil 750 mg (2 capsules providing approximately 180 mg EPA+DHA) with AquaCelle

Adherence will be monitored by product return at completion of participation.
Intervention code [1] 317840 0
Treatment: Other
Comparator / control treatment
The comparator groups are:
- Standard fish oil 800 mg (1 capsule providing approximately 500 mg EPA+DHA)
- Krill Oil 750 mg (2 capsules providing approximately 180 mg EPA+DHA)

Participants will take the allocated investigational product daily for a period of 8 weeks. Additional fasting blood samples will be taken at 2,4,6 and 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 324141 0
Change in cellular EPA concentrations as measured by blood plasma concentrations
Timepoint [1] 324141 0
Baseline, 2, 4, 6 and 8 weeks.
Primary outcome [2] 324142 0
Changes to Omega-6:3 ratio as measured in red blood cell concentrations
Timepoint [2] 324142 0
Baseline, 2,4,6 and 8 weeks.
Primary outcome [3] 324143 0
Time to change (speed of response) in omega 3 plasma levels via serum assay over an 8 week period
Timepoint [3] 324143 0
Baseline 2, 4, 6 and 8 weeks.
Secondary outcome [1] 383859 0
Cholesterol profile measured via serum assay (total cholesterol, LDL and HDL)
Timepoint [1] 383859 0
Baseline, 2, 4, 6 and 8 weeks
Secondary outcome [2] 383860 0
Evaluate tolerability of product through study specific questionnaire
Timepoint [2] 383860 0
Baseline, 2, 4, 6, and 8 weeks.
Secondary outcome [3] 383861 0
Assess product tolerability through reporting of adverse events (e.g. gastrointestinal upset) collected by phone or face to face interview.
Timepoint [3] 383861 0
Baseline, 2, 4, 6, and 8 weeks
Secondary outcome [4] 384913 0
Additional Primary outcome - Change in cellular DHA concentrations as measured by blood plasma concentrations
Timepoint [4] 384913 0
Baseline, Week 2, 4, 6 and 8.
Secondary outcome [5] 384914 0
Assess fatty acid profile measured by blood concentrations via serum assay (including Myristic, Palmitic, Palmitelaidic, Palmitoleic, Stearic, Elaidic, Oleic, Linoelaidic, Linoleic, Arachidic, gamma-Linolenic, Eicosenoic, alpha-Linolenic, Eicosadienoic, Behenic, Dihomo-g-linolenic, Arachidonic, Lignoceric, Eicosapentaenoic, Nervonic, Docosatetraenoic, Docosapentaenoic - n6, Docosapentaenoic - n3, Docosahexaenoic)
Timepoint [5] 384914 0
Baseline, Week 2, 4, 6, and 8.

Eligibility
Key inclusion criteria
- Men and women aged over 18 years with normal dietary habits (no medically prescribed diet or slimming diet)
- No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including
uncontrolled diabetes or thyroid disease) or haemotogical abnormalities that are uncontrolled.
- Participant’s full agreement and ability to consent to participation in the study
- Participant’s ability to participate fully and comply with demands of the study including
attendance at all scheduled blood collection time points.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Allergy to fish or shellfish
- Previous history of hematologic diseases (eg, known susceptibility to thrombosis)
- Concomitant use of anticoagulant drugs (eg Warfarin Sodium) and any other prescribed
medication except for females on the oral contraceptive pill
- Female participants currently pregnant or undergoing fertility treatment
- Regular use of supplements containing omega-3 fatty acids, regular consumption of foods
supplemented with omega-3 fatty acids such as some breads and milk products, consumption of fish as part of regular dietary patterns, high alcohol consumption (greater than 21 standard drinks/week)
- Reported participation in another omega-3 trial within 1 month before the start of the study
- Recent history (within 12 months) of substance abuse including alcohol
- Development of serious, adverse events/reactions including but not limited to; fainting, life threatening dehydration and/or serious bruising from blood sampling, excessive and prolonged
diarrhoea or gastrointestinal upset from fish oil consumption.
- Received treatment (radio &/or chemotherapy) for cancer (excluding SCC or BCC skin
cancer) in past 2 years.
- Current smoker.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2020
Date of last participant enrolment
Anticipated
26/06/2021
Actual
7/09/2020
Date of last data collection
Anticipated
26/11/2021
Actual
2/11/2020
Sample size
Target
80
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 305975 0
Commercial sector/Industry
Name [1] 305975 0
Pharmako Biotechnologies Pty Ltd
Country [1] 305975 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pharmako Biotechnologies Pty Ltd
Address
36 Campbell Ave Cromer
NSW 2099 AUS
Country
Australia
Secondary sponsor category [1] 306436 0
Commercial sector/Industry
Name [1] 306436 0
RDC Global Pty Ltd
Address [1] 306436 0
3B/76 Doggett Street, Newstead, QLD 4006
Country [1] 306436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306215 0
Bellberry Limited
Ethics committee address [1] 306215 0
Ethics committee country [1] 306215 0
Australia
Date submitted for ethics approval [1] 306215 0
Approval date [1] 306215 0
01/05/2020
Ethics approval number [1] 306215 0

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

Contacts
Principal investigator
Name 103126 0
Dr David Briskey
Address 103126 0
RDC Global Pty Ltd
3B/76 Doggett Street Newstead, QLD, 4006
Country 103126 0
Australia
Phone 103126 0
+61421 784 077
Fax 103126 0
Email 103126 0
[email protected]
Contact person for public queries
Name 103127 0
Amanda Rao
Address 103127 0
RDC Global Pty Ltd
3B/76 Doggett Street Newstead, QLD 4006
Country 103127 0
Australia
Phone 103127 0
+61 414 488 559
Fax 103127 0
Email 103127 0
[email protected]
Contact person for scientific queries
Name 103128 0
Amanda Rao
Address 103128 0
RDC Global Pty Ltd
3B/76 Doggett Street Newstead, QLD 4006
Country 103128 0
Australia
Phone 103128 0
+61 414 488 559
Fax 103128 0
Email 103128 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
No IPD will be shared


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.