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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT06758856
Eligibility Criteria:
Inclusion Criteria:
* Male or female participant of any race or ethnicity between 18-70 years of age (inclusive) at the time of informed consent
* BMI between 25-35 kg/m2
* Non-smoker
* Willing to consume 3 eggs per day for one dietary period of 4 weeks
* Willing to avoid eggs during the rest of the study including washout period breaks except for eggs that are provided
* Willing to fast before the baseline and dietary period lab visits
* Willing to provide a 24-hr prior day food record at the dietary period lab visits
* Willing to provide or collect biological specimen samples at the baseline and dietary period lab visits
* Willing to follow the study protocol including maintaining usual lifestyle during the entire study
Exclusion Criteria:
* Male or female \< 18 years or \> 70 years of age at the time of consent
* BMI \< 25 kg/m2; or BMI \> 35 kg/m2
* Pregnant or planning to become pregnant during the course of the study; currently breastfeeding or postpartum \< 6 months
* Use of hormone therapy including birth control pills
* Follows a vegan diet
* Current smoker (any form of nicotine, e-cigarettes, etc)
* Use of recreational drugs (may affect metabolic pathway for choline)
* Presence of chronic illnesses, e.g., heart disease, diabetes, cancer, celiac disease, inflammatory bowel disease (Crohn's disease and ulcerative colitis), gastrointestinal liver or kidney diseases or alcoholism
* Diagnosis of trimethylaminuria (genetic disorder affecting choline use in body)
* Use of antibiotics in the last 2 months
* Use of prebiotics, probiotics or dietary fiber (i.e., Metamucil) supplements in the last 2 months
* Have allergies to eggs or any anaphylactic food allergies
* Have a schedule or lifestyle patterns incompatible with the study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06758856
Study Brief:
Protocol Section:
NCT06758856