A Study in Healthy Subjects to Compare the Bioavailability of EPA + DHA (GOBO)

RDC Clinical

Status and phase: Active, not recruiting; Phase 4

Conditions: Healthy; Optimal Absorption of Omega-3

Treatments: Dietary Supplement: life's Omega O3020DS; Dietary Supplement: life's Omega 1035DS; Dietary Supplement: Fish Oil; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06629103

2023-5-12-GOBO

Details and patient eligibility

About

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

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. 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%

6. 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 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.
3. More specifically, history or presence of diabetes, high triglycerides (>150 mg/dL), or high cholesterol (>200 mg/dL).
4. Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
5. 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.
6. History of coagulation disorder or current anticoagulation therapy.
7. 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.
8. Has participated in another clinical trial (randomised participants only) within 30 days prior to the first dose of study medication.
9. 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.
10. Regular use (more than once per week) of omega-3 supplements (e.g., fish/krill/algae/flaxseed oil) within 2 months; or has consumed any omega-3 supplements or omega-3-rich foods (e.g., fortified products, or fatty fish >2x/week) within 14 days before the first dose.
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 more than 14 alcoholic drinks per week) within the past 2 years based on the judgement of the investigator.
13. Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
14. Has increase 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).

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's Omega 1035DS

Active Comparator group

Treatment:

Dietary Supplement: life's Omega 1035DS

life'sTM Omega O3020DS

Active Comparator group

Treatment:

Dietary Supplement: life's Omega O3020DS

MEG-3TM 1812 TG

Active Comparator group

Treatment:

Dietary Supplement: Fish Oil

Placebo

Placebo Comparator group

Treatment:

Other: Placebo