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:
NCT05921266
Eligibility Criteria:
Inclusion Criteria:
* Age: 40-64 years old, inclusive
* Obesity \[BMI ≥30 kg/m2\]
* Ability to read, write, and speak English
* Competence to provide written informed consent
Exclusion Criteria:
* Pregnant or breastfeeding women, or women who intend to become pregnant within the study period
* History of uncontrolled hypertension
* History of uncontrolled type 1 or type 2 diabetes mellitus
* Significant cardiac disease or chest pain in the last 6 months
* History of untreated depression or anxiety
* History of cognitive impairment
* History of uncontrolled significant GI disease (e.g., IBS, Crohn's disease)
* Allergy or intolerance to one or more of the intervention components
* Undergoing treatment for active cancer
* History of neurodegenerative disorders (e.g., multiple sclerosis)
* Presence of any condition affecting swallowing ability
* Any other medical condition that the investigators deem would adversely affect the participant's safety or ability to complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
64 Years
Study:
NCT05921266
Study Brief:
Protocol Section:
NCT05921266