Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT01564160
Eligibility Criteria:
Inclusion Criteria:
* The individual is fluent in English and understands the study requirements
* The participant is willing and able to comply with all requirements defined within this protocol.
* The individual is willing to provide written informed consent
* The individual is male or female
* The individual is between 18 and 65 years of age
* The individual's blood EPA+DPA+DHA ≤ 5.2% at screening
Exclusion Criteria:
* The individual is unable to or refuses to provide written informed consent
* The individual has taken omega-3 supplements within 3 months of screening.
* Supplements containing any of the following sources of omega-3s will exclude the individual from the study: fish oil, flax oil, krill oil, green-lipped mussel, chia, perilla, algea
* The individual's blood EPA+DPA+DHA ≥ 5.2% at screening
* The individual is female and pregnant or breastfeeding, or plans to be during the trial period
* The individual has known allergies product ingredients (fish/seafood)
* The individual has any significant medical illness or condition
* The individual has reported a history of drug dependence or substance abuse (excluding nicotine)
* The individual is taking lipid-altering medications (statins, niacin, carnitine, fibrates etc.)
* The individual is unable to abstain from caffeine, alcohol or physical activity for 24 hours before each treatment visit
* The individual will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the participant from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01564160
Study Brief:
Protocol Section:
NCT01564160