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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000836932

Acronym

LTFISH-20

Enrollment

Registered

2020-08-24

Start date

2020-07-03

Completion date

2020-09-07

Last updated

2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

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.

Outcome results