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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT05295134
Eligibility Criteria:
Inclusion Criteria:
1. Be able to give written informed consent
2. Be between 18 and 75 years of age
3. Be in generally good health as determined by the investigator
4. Serum triglyceride levels between 151 mg/dL (1.71 mmol/L) and 499 mg/dL (5.65 mmol/L)
Exclusion Criteria:
1. Are less than 18 and greater than 75 years of age
2. Females are pregnant, lactating or wish to become pregnant during the study
3. Are hypersensitive to any of the components of the test product,
4. Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigator's judgement, entry to the study
5. Have an active gastrointestinal disorder or previous gastrointestinal surgery
6. Have a known family history of hyperlipidemia
7. Having a condition or have taken a medication or supplement that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results, including triglyceride lowering medications (e.g., fibrates and statins) and supplements (e.g., plant sterols/stanols, fish oil supplements, and vitamin B complex supplements)
8. Have not made any major dietary changes in the past 3 months
9. History of illicit drug use
10. Subjects who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial
11. Subjects may not be receiving treatment involving experimental drugs
12. If the subject has participated in a recent experimental trial, the trial must have been completed not less than 60 days prior to this study
13. Have a malignant disease or any concomitant end-stage organ disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05295134
Study Brief:
Protocol Section:
NCT05295134