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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03956433
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible to the pilot study if they present with two to four of the criteria for metabolic syndrome (MetS), at least one of them being alteration of fasting triglycerides or HDL-C cholesterol. MetS is defined when three of the following criteria are met:
* elevated waist circumference (men ≥ 102 cm; women ≥ 88 cm)
* elevated fasting triglycerides (≥ 150 mg/dL)
* reduced fasting HDL-cholesterol (men ≤ 40 mg/dL; women ≤ 50 mg/dL)
* elevated blood pressure (systolic ≥ 130 mmHg and/or diastolic ≥ 85 mmHg) or hypotensive treatment
* elevated fasting glucose (≥ 110 mg/dL)
Exclusion Criteria:
Participants are excluded if three or more clinical criteria for metabolic syndrome are met. Additionally, major exclusion criteria are:
* regular drug therapy with impact on serum lipids;
* diabetes (fasting glucose \> 1.26 g/L, or anti-diabetic treatment);
* recent history of cancer or cancer treatment (less than 2 years);
* active or recently diagnosed intestinal malabsorption or disorders associated with malabsorption: Crohn's disease, short bowel syndrome, Pancreatic insufficiency , cystic fibrosis, Tropical Sprue, whipple's disease, chronic pancreatitis, gastrojejunostomy, surgical treatments for obesity, cholestasis, biliary atresia, parasite infections, HIV/AIDS
* familial dyslipidemia;
* use of medication known to cause malabsorption: tetracycline, cholestyramine, thiazide diuretics, aluminum/magnesium hydroxide, colchicine, neomycin, methotrexate, methyldopa, and allopurinol, and laxatives
* illegal drug use, chronic alcoholism or active smoking;
* intensive physical exercise (≥ 5 hour/week);
* consumption of nutritional supplements containing DHA, BG or AC;
* history of allergy or intolerance to any components used in BEFs, celiac disease, lactose intolerance, allergy to milk or egg proteins;
* institutionalised patients, those who lack autonomy to consent or are unable to meet all examinations;
* women who are pregnant, lactating or actively trying to conceive;
* participation in other clinical trials that may impact on outcome;
* subjects deprived of their liberty by judicial or administrative decision.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03956433
Study Brief:
Protocol Section:
NCT03956433