Phase
Condition
N/ATreatment
Fish Oil
life's Omega 1035DS
Placebo
Clinical Study ID
Ages 18-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Written informed consent obtained before any trial related assessments areperformed.
- Healthy adult females ages 18-64 who are neither pregnant nor breastfeeding orhealthy 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 toscreening, are considered not to be of child-bearing potential), who are notsurgically sterilized, must have a negative pregnancy test at screening and bewilling to practice one of the following appropriate contraceptive methods until thelast visit: i. Sexual abstinence. ii. Oral contraceptives. iii. Trans dermal patchesor depot injection of a progestogen drug (starting at least 4 weeks prior to productadministration). iv. Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, orvaginal ring (placed at least 4 weeks prior to product administration). Contraceptives must be effective before the randomization visit.
Participant's body mass index (BMI) must be between 18 and 30 kg/m2 (inclusive) andparticipant must weigh a minimum of 50 kg (110 lbs)
Intakes of EPA+DHA of less than 200mg per day based on the FFQ
Omega-3 Index less than 4%
Agree not to change current diet and exercise frequency or intensity during entirestudy period
Exclusion
Exclusion criteria:
Participant has any health conditions that would prevent from fulfilling the studyrequirements, put the participant at risk or would confound the interpretation ofthe study results as judged by the Investigator on medical history and routinelaboratory test results.
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 theopinion of the Investigator, would jeopardize the safety of the participant or thevalidity of the study results.
More specifically, history or presence of diabetes, high triglycerides (>150 mg/dL),or high cholesterol (>200 mg/dL).
Has a clinically significant abnormal finding on the medical assessment, medicalhistory, vital signs or clinical laboratory results at screening.
History or presence of allergic or adverse response to omega-3-acid ethyl esters ortriglycerides (EPA or DHA), or related drugs, or sensitivity or allergy to fish orshellfish.
History of coagulation disorder or current anticoagulation therapy.
Has been on a significantly abnormal* diet, as deemed by the investigator, duringthe 4 weeks preceding the first dose of study medication. *an abnormal diet will beconsidered if the participant has elected to change to a more or less restricteddiet of any description (e.g., change to or from a vegetarian, vegan, gluten-free,lactose-free, etc.) or significantly increases or decreases their daily caloricintake.
Has participated in another clinical trial (randomised participants only) within 30days prior to the first dose of study medication.
Has used prescription medication (excluding oral contraceptive and hormonalreplacement therapy) within 4 weeks of screening or OTC medication within 7 daysbefore the first dose that may affect omega-3 absorption or any study outcomes. Thismay 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.
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-3supplements or omega-3-rich foods (e.g., fortified products, or fatty fish >2x/week)within 14 days before the first dose.
Has smoked or used tobacco products within 60 days prior to the first dose of studymedication.
History of substance abuse or treatment (including more than 14 alcoholic drinks perweek) within the past 2 years based on the judgement of the investigator.
Has a positive urine screen for drugs of abuse (amphetamines, barbiturates,benzodiazepines, cocaine, cannabinoids, opiates).
Has increase bleeding from existing pathological conditions or anticipates surgeryprior to, throughout, or within 1 week after study participation.
Has any dental appointment scheduled throughout or within 1 week after studyparticipation.
Has had a transient ischemic attack (TIA) or stroke or is at high risk for recurrentischemic events.
Has had or currently has lesions with a propensity to bleed (such as ulcers).
Study Design
Connect with a study center
RDC Clinical
Brisbane, Queensland 4000
AustraliaSite Not Available
RDC Clinical
Brisbane 2174003, Queensland 2152274 4000
AustraliaSite Not Available

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