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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT05984550
Eligibility Criteria:
Inclusion Criteria:
1. Male/females of 18 to 80 years of age.
2. Able to provide written Informed Consent.
3. BMI 25.0-44.9 kg/m².
4. Able to follow verbal and written study directions.
5. Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
6. Able to maintain consistent diet and lifestyle habits according to the study.
Exclusion Criteria:
* 1\. Diabetes.
2.Premenopausal or menopause \<1 year.
3.Persons who have received hormone replacement therapy within the past 6 months.
4.Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
5.Unstable weight (\>3% change during the last 2 months before entering the study).
6.Significant organ system dysfunction or disease.
7.Present cancer or history of cancer that has been in remission for \<5 years.
8.Polycystic ovary syndrome.
9.Major psychiatric illness.
10.Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study.
11.Metal implants.
12.Persons who consume \>14 units of alcohol per week.
13.Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05984550
Study Brief:
Protocol Section:
NCT05984550