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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT03201068
Eligibility Criteria:
Inclusion Criteria:
* 18 and older
* Must have metabolic syndrome as defined by having at least 2 of the 5 criteria per either ATP III guidelines OR International Diabetes Federation (IDF) guidelines:
ATP III guidelines:
1. Abdominal obesity, defined as a waist circumference in men ≥102 cm (40 in) and in women ≥88 cm (35 in)
2. Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
3. Serum high-density lipoprotein (HDL) cholesterol \<40 mg/dL (1 mmol/L) in men and \<50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL cholesterol
4. Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
5. Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose
International Diabetes Federation Guidelines:
1. Increased waist circumference, with ethnic-specific waist circumference cut-points:
White and all other ethnic groups - Men ≥ 94 cm; Women ≥ 80 cm South Asians, Chinese, and Japanese - Men ≥ 90 cm; Women ≥ 80 cm
PLUS any two of the following:
2. Triglycerides ≥150 mg/dL (1.7 mmol/L) or treatment for elevated triglycerides
3. HDL cholesterol \<40 mg/dL (1.03 mmol/L) in men or \<50 mg/dL (1.29 mmol/L) in women, or treatment for low HDL
4. Systolic blood pressure ≥130, diastolic blood pressure ≥85, or treatment for hypertension
5. FPG ≥100 mg/dL (5.6 mmol/L) or previously diagnosed type 2 diabetes; an oral glucose tolerance test is recommended for patients with an elevated fasting plasma glucose, but not required.
Exclusion Criteria:
* Body Mass Index (BMI) ≥ 40
* LDL \>160 mg/dL.
* Vital signs outside of acceptable range at Screening Visit: blood pressure \>159/99, oral temperature ≥ 100°F, pulse \>100.
* Use of any of the following drugs within the last 6 months:systemic antibiotics (must be discontinued and avoided for 2 months prior to the study start), antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or immunosuppressive cytotoxic agents;
* Use of large doses of commercial probiotics consumed within the last 6 months (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (must be discontinued and avoided for one month prior to the study start). Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03201068
Study Brief:
Protocol Section:
NCT03201068