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 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT02653495
Eligibility Criteria:
Inclusion criteria for the METABOLIC SYNDROME COHORT( Participants must have 3 or more of the following 5 risk factors):
* Abdominal Obesity, given as a waist circumference: Men \>102 cm (\>40 in) Women \> 88 cm (\>35 in)
* Triglycerides \>150 mg/dl
* HDL Cholesterol: Men \< 40 mg/dl Women \< 50 mg/dl
* Blood Pressure \>130/ \>85 mm Hg - or controlled on antihypertensive medication
* Fasting Glucose \> 100 mg/dl
Inclusion criteria for the HEALTHY CONTROLS (Participants must have all of the requirements below) :
* body mass index 18.5 - 25 kg/m2
* HDL female \> 50 mg/dL, male \> 40 mg/dL
* fasting glucose \< 100 mg/dL
* triglycerides \<150 mg/dL,
* waist circumference of a female \< 88 cm, male \< 102 cm)
* \- Blood pressure \< or = to 120/80 (based on an average of 3 readings taken 5 minutes apart after the consent form has been signed)
Exclusion criteria :
* Currently undergoing treatment for the metabolic syndrome
* The average of 2 BP readings \> 150/90 (based on 2 B/Ps taken at screening visit 1).
* Hepatitis A, B and C
* NSAIDs and/or Aspirin ingestion within the last 14 days
* Self-reported history of any active autoimmune diseases
* Self-reported ingestion of statins within the last 3 months
* Self-reported antibiotic use within the last 3 months
* Anti-inflammatory drugs including biologics and corticosteroids within last 3 months( nasal spray and topical applications are OK)or Omega 3 Fatty Acids.
* Self-reported hx of cancer treatment within the last year
* Allergy to eggs
* History of Guillain-Barre syndrome
* Pregnant ( determined by point of care testing at screening visit 1).
* HIV positive
* Self-reported history of flu vaccination within the past 3 months.
* Any self-reported infection in the week of the visit except the first two visits (Screening visit 1 and Screening visit 2) and the last visit (Study visit #5) that could be rescheduled.
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Study Population Description The population from which the groups will be selected are resident of New York City.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02653495
Study Brief:
Protocol Section:
NCT02653495