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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT03458494
Eligibility Criteria:
Inclusion Criteria:
* Men and women.
* 18 years or older.
* Women who are not pregnant.
* A BMI ranging between 27 and 34
Exclusion Criteria:
* Unexplained elevation in serum transaminases (i.e. \>1.5 times the upper limit of normal) or with evidence of active liver disease, including primary biliary cirrhosis or pre-existing gallbladder disease.
* Severe renal dysfunction (serum creatinine \>2.0mg/dL).
* Excessive alcohol consumption (\>2 drinks/day).
* Preexisting CVD.
* Stable exertional angina pectoris requiring sublingual nitroglycerin within the prior 3 months.
* Uncontrolled T2D (fasting glucose \>126 mg/dl) or other significant endocrine disease.
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg).
* History of pancreatitis within 1 yr. prior to screening.
* Subjects on lipid-lowering or diabetes medications.
* Smoking.
* Pregnancy.
* Body mass index (BMI) below 27 or greater than 34 kg/m2
* Participants will also be excluded for drug abuse, extreme dietary habits, multiple food allergies, extreme levels of physical or athletic activity, or by changes in body weight \>20 lbs. during the last 6 months.
* Inability to follow any of the experimental diets or to perform the sampling required for this study.
* Thyroid diseases.
* Use of omega-3 supplements (unless it is discontinued one month prior to the beginning of the study).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03458494
Study Brief:
Protocol Section:
NCT03458494