A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo (GOBO 2)

RDC Clinical

Status and phase: Enrolling; Phase 3

Conditions: Healthy Participants; Absorption of Omega-3; Omega-3 Supplementation

Treatments: Other: Placebo; Dietary Supplement: life'sTM omega O3020DS nTG; Dietary Supplement: MEG-3 3323rTG; Dietary Supplement: life'sTM omega O1035DS nTG

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07241377

2024-20-08-GOBO2

Details and patient eligibility

About

This is a randomised, double-blind, parallel, placebo-controlled study in healthy adults to compare the absorption of two microalgal formulations, to a fish oil and a placebo. Participant will take their assigned study product for 6 weeks and attend the clinic for 4 visits.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent obtained before any trial related assessments are performed.

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).

   v. 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 <200 mg per day based on the FFQ

5. Agree not to change current diet and exercise frequency or intensity during entire study period

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 based on medical history and routine laboratory test results.
2. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematologic, 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 subject or the validity of the study results.
3. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
4. 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, or soybean or corn.
5. History of coagulation disorder or current anticoagulation therapy.
6. Has been on a significantly abnormal* diet, as deemed by the investigator, during the 4 weeks preceding the first dose of study medication. *an abnormal diet will be considered if the participant has elected to change to a more or less restricted diet of any description (e.g., change to or from a vegetarian, vegan, gluten-free, lactose-free, etc.) or significantly increases or decreases their daily caloric intake.
7. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
8. Has used prescription medication (excluding oral contraceptive and hormonal replacement therapy) within 4 weeks of screening or OTC medication within 7 days before the first dose that may affect omega-3 absorption or any study outcomes. This may include but is not limited to: high-dose NSAIDs, bile acid sequestrants, statins, GLP-1 receptor agonists, anticoagulants and anti-inflammatory drugs. Occasional ibuprofen, paracetamol and low-dose aspirin use is permitted.
9. Regular use* of omega-3 supplements and/or regular fatty fish consumption within 2 months. *Regular use is defined as more than once per week of either fish oil, krill oil, microalgal oil supplements, or fatty fish.
10. Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
11. History of substance abuse or treatment (including more than 14 alcoholic drinks per week) within the past 2 years based on the judgement of the investigator.
12. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
13. Has increased bleeding from existing pathological conditions or anticipates surgery (including dental) prior to, throughout, or within 1 week after study participation.
14. Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrent ischemic events

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

life'sTM Omega O1035DS nTG

Experimental group

Description:

life'sTM Omega O1035DS is a nTG derived from microalgae with minimum 365 mg DHA, minimum 100 mg EPA, and minimum 520 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks.

Treatment:

Dietary Supplement: life'sTM omega O1035DS nTG

life'sTM Omega O3020DS nTG

Experimental group

Description:

life'sTM Omega O3020DS is a nTG derived from microalgae with minimum 210 mg DHA, minimum 300 mg EPA, and minimum 510 mg/g DHA + EPA. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks.

Treatment:

Dietary Supplement: life'sTM omega O3020DS nTG

MEG-3TM 3223 rTG

Active Comparator group

Description:

The fish oil will be MEG-3TM 3223 rTG with minimum 230 mg DHA, minimum 320 mg EPA, and minimum 640 mg/g Omega-3. All Omega-3 oils will be diluted with high oleic sunflower oil for a total (EPA + DHA) content of 300 mg/capsule. Each subject will consume three capsules for a total intake of 900 mg (EPA+DHA)/day for 6 weeks.

Treatment:

Dietary Supplement: MEG-3 3323rTG

Placebo

Placebo Comparator group

Description:

The placebo capsules will be a mixture of corn and soybean oils. 515 mg corn oil and 515 mg soybean oil. Each subject will consume three capsules for a day for 6 weeks.

Treatment:

Other: Placebo