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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02465294
Eligibility Criteria:
Inclusion Criteria:
To participate in the study you must:
* Be age 18 to 75 years
* Have a BMI ≥ 25
* Be willing to receive random assignment to probiotic or placebo supplementation
* Be willing to and able to complete the Informed Consent Form in English
* Be willing to complete questionnaires, records, and diaries associated with the study and to complete all study visits
* Be committed to losing weight over the 12-week study period
* Be willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements).
* Be willing to provide a social security number (SS#) to receive study payment? Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
Exclusion Criteria:
To participate in the study you must NOT:
* Have used another investigational product within 3 months of enrolling in the study
* Be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months
* Be allergic to milk, soy, or yeast
* Have gained or lost at least 10 lbs in the previous 3 months
* Have had uncontrolled angina (severe chest pain) within the past 6 months
* Have insulin-dependent diabetes (oral medications are not exclusionary)
* Use weight-loss medications
* Have had cancer treatment (radiation, chemotherapy, or surgery) within the past 6 months or any other treatment or condition known to weaken the immune system (e.g., systemic corticosteroids or HIV/AIDS)
* Be currently being treated for or have any of the following physician-diagnosed diseases or conditions: inflammatory bowel disease, celiac disease, short bowel syndrome, or any other malabsorptive syndrome?
* Have any physical condition deemed likely to significantly interfere with your ability to participate in a lifestyle intervention involving eating and physical activity changes
* Be currently participating in Weight Watcher's or another weight loss program
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02465294
Study Brief:
Protocol Section:
NCT02465294