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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT02840357
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 25 kg/m2 and/or Waist circumference ≥102 cm (men) and ≥88 cm (women)
* hs-CRP: ≥ 1.0 mg/L at time of screening
* Stable (\>3 months) and consistent use of all prescribed medications and/or supplements
* Non- to moderate alcohol consumer (i.e. less than 5 drinks per sitting and no more than 14 per week)
* Not taking any antibiotics within the last 3 months, or planning to take antibiotics within the next 6 months
Exclusion Criteria:
* Pregnant or breastfeeding females
* Lifetime history of any acute medical event, including but not limited to, heart attack or stroke
* Occasional or intermittent smoker (includes but not limited to tobacco and cannabis)
* Consistent smoker of \<1 year
* Recent diagnosis (within 6 months) of a serious medical condition, including but not limited to, cancer, diabetes, heart disease or hepatitis
* Recent history (within 6 months) of a clinically significant psychiatric disorder, other than mild depression
* Any disorder of the gastrointestinal system or food intolerances, including but not limited to, inflammatory bowel disease or Celiac disease
* Any food allergies or any life-threatening allergies, food or otherwise
* Regular recreational drug use of more than once per week, including but not limited to cannabis, magic mushrooms, ecstasy etc
* Difficulty providing blood samples
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02840357
Study Brief:
Protocol Section:
NCT02840357