Clinical trial NCT06629103: A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA
Official title: A Randomized, Double-blind Placebo-controlled Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA from Two Microalgal Sources to One Fish Source
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Optimal Absorption of Omega-3
Healthy
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomised, double-blind placebo-controlled study in healthy subjects to compare the absorption of two microalgal formulations, to a fish oil and a placebo.


Eligibility criteria: Inclusion criteria:

1. Written informed consent obtained before any trial related assessments are performed.
2. 2. Healthy adult females ages 18-64 who are neither pregnant nor breastfeeding or healthy adult males ages 18-64 at the time of consent.

   a. Female participants of child-bearing potential (females who are post-menopausal, i.e., when there has been no menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until the last visit: i. Sexual abstinence. ii. Oral contraceptives. iii. Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).

   iv. Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration).

   Contraceptives must be effective before the randomization visit.
3. Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) and participant must weigh a minimum of 50 kg (110 lbs)
4. Intakes of EPA+DHA of less than 200mg per day based on the FFQ
5. Omega-3 Index less than 4%

Exclusion criteria:

1. Participant has any health conditions that would prevent from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the Investigator on medical history and routine laboratory test results.
2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.

   1. More specifically, history or presence of diabetes, high triglycerides (greater than 150 mg/dL), or high cholesterol (greater than 200 mg/dL).
   2. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
   3. History or presence of allergic or adverse response to omega-3-acid ethyl esters or triglycerides (EPA or DHA), or related drugs, or sensitivity or allergy to fish or shellfish.
   4. History of coagulation disorder or current anticoagulation therapy.
   5. Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
   6. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
   7. Has used any over the counter (OTC) medication within 7 days prior to the first dose of study medication. (except for occasional Ibuprofen and Paracetamol use)
   8. Has used omega-3 supplements, fish oil, krill oil, or flaxseed within 2 months prior to the first dose of study medication.
   9. Has consumed canola oil, walnuts, or any product supplemented with omega-3 fatty acids (e.g., orange juice) or fatty fish more than 2x/week within 14 days prior to the first dose of study medication.
   10. Has used any prescription medication within 4 weeks of the screening visit; except hormonal contraceptive, hormonal replacement therapy, or occasional use of ibuprofen or paracetamol.
   11. Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
   12. History of substance abuse or treatment (including alcohol) within the past 2 years.
   13. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
   14. Has increased bleeding from existing pathological conditions or anticipates surgery prior to, throughout, or within 1 week after study participation.
   15. Has any dental appointment scheduled throughout or within 1 week after study participation.
   16. Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrent ischemic events.
   17. Has had or currently has lesions with a propensity to bleed (such as ulcers).

Primary outcomes:
measure: To compare the bioavailability of 600mg/d of Omega-3 fatty acids by comparing the change from baseline in sum level EPA and DHA in plasma phospholipids across all treatments at the end of 6 weeks supplementation study.
timeFrame: 6 weeks
Secondary outcomes:
measure: To compare the bioavailability by 600mg/day of Omega-3 fatty acids by comparing the change from baseline in the sum level of EPA and DHA in plasma phospholipids across all treatments at the end of a 2, 4, and 6 week supplementation study.
timeFrame: 2, 4 and 6 weeks
measure: To compare the bioavailability of 600mg/day of Omega-3 fatty acids by comparing the change from baseline in Omega-3 Index across all treatments at the end of a 6 week supplementation study.
timeFrame: 6 weeks
measure: To compare the bioavailability of 600mg/day Omega-3 fatty acids by comparing the change from baseline in the plasma phospholipid levels across all treatments at week 2 and week 4 of supplementation.
timeFrame: 2 and 4 weeks
measure: To compare the changes from baseline in lipoprotein levels following consumption of the microalgal oils, fish oil or placebo at the end of a 6-week supplementation study.
timeFrame: 6 weeks
Other outcomes:
measure: Additional endpoint 1
timeFrame: 2, 4 and 6 weeks
measure: Additional endpoint 2
timeFrame: 2, 4 and 6 weeks
measure: Additional endpoint 3
timeFrame: 6 weeks
measure: Additional endpoint 3
timeFrame: 6 weeks
measure: Additional endpoint 3
timeFrame: 6 weeks
measure: Safety Endpoint 1
timeFrame: 6 weeks
measure: Safety Endpoint 2
timeFrame: 6 weeks
measure: Safety Endpoint 2
timeFrame: 6 weeks
measure: Safety Endpoint 2
timeFrame: 6 weeks
measure: Safety Endpoint 3
timeFrame: 6 weeks
measure: Safety Endpoint 3
timeFrame: 6 weeks
measure: Safety Endpoint 4
timeFrame: 6 weeks
measure: Safety Endpoint 5
timeFrame: 6 weeks
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
affiliation: RDC Clinical
name: David Briskey
role: PRINCIPAL_INVESTIGATOR
References: