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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07373392
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years
* Prediabetes (FPG 100-125 mg/dL or HbA1c 42-47 mmol/mol), or Type 1 or Type 2 diabetes
* Elevated cholesterol or triglycerides (TC ≥200 mg/dL, LDL 130-189 mg/dL, or TG \>150 mg/dL)
* Either no lipid-lowering medication or stable dose for ≥4 weeks
* Able to swallow capsules and understand Danish
* Willing to maintain lifestyle habits and provide stool and blood samples
Exclusion Criteria:
* Antibiotic use in the past 3 months
* Severe dyslipidemia (\>500 mg/dL triglycerides)
* Significant liver, kidney, thyroid disease
* Pregnancy or breastfeeding
* GI surgery or chronic GI disease (IBD, IBS, Crohn's disease)
* Long-term medications influencing lipid/glucose metabolism (except approved antidiabetic medications)
* Participation in another trial within 3 months
* Capsule intake \<80%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07373392
Study Brief:
Protocol Section:
NCT07373392