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 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 1:37 AM
NCT ID:
NCT03719794
Eligibility Criteria:
Inclusion Criteria:
* Male and female age \> 50 years
* Presence of MetS as defined according to recent updated criteria (13): Presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off) depending on the recently published ethnic-based variations (14), triglycerides \> 1.70 mmol/l, decreased HDL-cholesterol (\< 1.0 mmol/l in men and \< 1.3 mmol/l in women), systolic blood pressure \> 130 mmHg or diastolic blood pressure \> 85 mmHg, and FPG \> 5.6 mmol/l.
* Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
* Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements).
* Able to provide informed consent.
Exclusion Criteria:
* Concurrent consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements). Subjects will be eligible for participation, however, after a two-week washout period
* Overt or documented vascular disease (coronary heart disease, cerebrovascular disease, or peripheral vascular disease).
* Participants suffering from dementia (mini mental state examination) or depression (geriatric depression scale).
* Concurrent statin therapy. (Statins have been shown to reduce vascular inflammation as measured by FDG-PET-see section 9.1).
* Color blind
* Concurrent antibiotic therapy. However, screened participants would be eligible to participate two weeks after completing their course of antibiotics (wash-out period).
* Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
* Women of childbearing potential not using effective contraception. Acceptable methods of birth control includes:
* Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants;
* Intrauterine devices (IUD) or Intrauterine system (IUS);
* Tubal ligation;
* Vasectomy of partner;
* Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap).
* Positive pregnancy test in women of childbearing potential.
* Allergy to milk, soy, or yeast.
* Use of another investigational product within 3 months of the screening visit.
* Claustrophobia
* Patient with pacemaker
* Patient with BMI greater than 40 kg/m2
* Immune disorder.
* Drug and alcohol abuse
* Current use of NSAIDs
* Liver and kidney disorders
* Bleeding/blood disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03719794
Study Brief:
Protocol Section:
NCT03719794