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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02924558
Eligibility Criteria:
Inclusion Criteria:
* Fasting TG level 150-499 mg/dL
* Body mass index (BMI) 25.0-39.9 kg/m2
* Score of 7-10 on Vein Access Scale
* Normally active and judged to be in general good health on basis of medical history and routine laboratory tests
Exclusion Criteria:
* Fasting blood glucose ≥126 mg/dL or known type 1 or type 2 diabetes mellitus
* Atherosclerotic cardiovascular disease
* Recent history or current significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease
* Abnormal lab test results of clinical significance (e.g., creatinine ≥1.5 mg/dL and aspartate or alanine transaminase ≥1.5 times upper limit of normal)
* History of cancer in previous 2 years
* Uncontrolled hypertension
* Recent unstable use of anti-hypertensive medication, thyroid hormone replacements, and/or medications known to substantially influence carbohydrate metabolism
* Recent use of certain blood pressure medications (e.g., beta-adrenergic blockers and/or high-dose thiazide diuretics)
* Recent use of lipid-altering drugs (e.g., statins, bile acid sequestrants, cholesterol absorption inhibitors, or fibrates)
* Recent use of diabetes medication (e.g., alpha-glucosidase inhibitors, biguanides and biguanide combinations, bile acid sequestrants, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, meglitinides, and sulfonylureas and combination sulfonylureas)
* Recent use of lipid-altering foods, herbs, or dietary supplements (e.g., niacin, sterol/stanol products, dietary fiber supplements, red rice yeast supplements)
* Recent unstable use of herbs and dietary supplements that may influence carbohdyrate metabolism
* Extreme dietary habits, dietary restrictions, or significant food allergies
* Required energy intake \<2200 kcal/day or \>3400 kcal/day
* Recent change in body weight of ±4.5 kg
* Recent use of weight loss drugs or programs
* Active infection or on antibiotic therapy
* Current or recent history of drug or alcohol abuse
* Pregnant, planning to be pregnant, or lactating females or women of childbearing potential unwilling to commit to use of a medically approved form of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT02924558
Study Brief:
Protocol Section:
NCT02924558