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NCT07241377
A Study in Healthy Adults to Compare the Bioavailability of EPA + DHA From Two Microalgal Sources to One Fish Source and Placebo
Conditions: Absorption of Omega-3, Omega-3 Supplementation, Healthy Participants
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 120
Sponsor: RDC Clinical Pty Ltd
Location: RDC Clinical Fortitude Valley Queensland
Summary
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.
Eligibility Criteria
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. 3\. Participant's body mass index (BMI) must be between 18 and 32 kg/m2 (inclusive), and considered to be of healthy weight in the opinion of the investigator.
4. Intakes of EPA+DHA of \
Source: ClinicalTrials.gov (NCT07241377). StuddyBuddy aggregates publicly available trial information.