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:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02729857
Eligibility Criteria:
Inclusion Criteria:
* 18 - 30 years of age
* Healthy or diagnosed with familial hypercholesterolemia (FH) (mutation in gene coding for LDL-receptor). FH subjects can be included if they are:
1. Untreated
2. Treated with low dose statin (\<20 mg atorvastatin, \<10-20 mg simvastatin or \<5-10 mg rosuvastatin)
3. Treated with high dose statin and willing to use low dose statin during the last 4 weeks prior to both study visits (total 8 week period)
4. Treated with high dose statins and willing to discontinue statin treatment during the last 4 weeks prior to both study visits (total 8 week period)
* BMI 18.5 - 30 kg/m2
* Stabile weight the last three months prior to the first study visit (weight change less than ± 5 % of body weight)
Exclusion Criteria:
* CRP \>10 mg/L
* TG \>4 mmol/L
* Comorbidities including diabetes type I and II, coronary heart disease, haemophilia, anaemia, gastro intestinal disease, renal failure and hyperthyroidism
* Pregnant or lactating
* Allergic or intolerant to gluten or egg
* Not willing to stop using n-3 fatty acid supplements during the last 4 weeks prior to both study visits
* Using medications affecting lipid metabolism or inflammation, except statins for FH subjects
* Hormone treatment (except contraception and thyroxin (stabile dose last 3 months))
* Donating blood 2 months within or during study period
* Tobacco smoking
* Large alcohol consumption (\>40g daily)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT02729857
Study Brief:
Protocol Section:
NCT02729857