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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01729793
Eligibility Criteria:
Inclusion Criteria:
1. If female, not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgical with \>1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
2. Healthy as determined by laboratory results, medical history and physical exam
3. Agrees to comply with study protocols
4. Has given voluntary, written, informed consent to participate in the study -
Exclusion Criteria:
1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
2. Gastrointestinal lesions/ulcer, diabetes, or any condition requiring the use of prescribed medications for treatment
3. Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
4. History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable.
5. History of bleeding disorders, or significant blood loss in the past 3 months
6. Use of blood thinning medications.
7. Use of anti-inflammatory medications, including over-the-counter pain relievers within the past 14 days.
8. Use of prescription medication (other than birth control), vitamins, minerals or other natural health products within the past 3 days. .
9. Alcohol use \>2 standard alcoholic drinks per day and/or alcohol or drug abuse within the past year
10. Allergy or sensitivity to study supplement ingredients, study meal ingredients or allergy or sensitivity to yeasts or molds/fungi.
11. Participation in a clinical research trial within 30 days prior to randomization
12. Individuals who are cognitively impaired and/or who are unable to give informed consent
13. Use of fish oil supplements within 10 days of randomization and during the trial
14. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT01729793
Study Brief:
Protocol Section:
NCT01729793