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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT06195566
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult volunteers (age ≥ 18 years old);
* Overweight (BMI 25 - 29.9 kg/m2) and obese grade I individuals (with BMI 30 - 34.9 kg/m2);
* Written consent of the participant after being informed;
* Ownership of a smartphone running Android or iOS.
Exclusion Criteria:
* Non-compliance;
* Ongoing treatment with immunosuppressive and/or anti-inflammatory medications (NSAIDs, glucocorticoids, chemotherapy, biologicals);
* Ongoing treatment with glucose lowering drugs, except if anti-diabetic medication has not been stopped - for metformin one month, for GLP-1 RA, tirzepatide - two months prior enrolment;
* Presence of autoimmune and/or inflammatory disease (autoimmune thyroid disease, psoriasis, inflammatory bowel disease);
* Skin conditions hindering application of continuous glucose monitoring systems;
* Diabetes or prediabetes as diagnosed by ADA/WHO criteria according to fasting glucose and/or HbA1c;
* High risk alcohol consumption - according to NIAAA - National Institute on Alcohol Abuse and Alcoholism (for men - more than 4 drinks on any day or more than 14 drinks per week; for women - more than 3 drinks on any day or more than 7 drinks per week);
* Factors otherwise limiting the participation in the study according to the judgement of the investigator;
* Pregnancy or intention to get pregnant during the study timeline.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06195566
Study Brief:
Protocol Section:
NCT06195566