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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT04910061
Eligibility Criteria:
Inclusion Criteria:
* Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
* Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using an acceptable methods of birth control.
* BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg).
* Having given written informed consent to participate in the research trial.
* Agrees to maintain current dietary habits and level of physical activity for the trial duration, except as directed by the Nutritionist Agrees to follow dietary guidelines, consume standardized meals, and abide by dietary guidelines for dinner prior to specified visits (as outlined by Nutritionist at screening)
Exclusion Criteria:
* Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
* Active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by Investigator.
* Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
* Have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by Investigator.
* Has consumed multivitamins or supplements (such as St. John's Wort) within 1 month prior to the study, or unwilling to discontinue use for the duration of the study
* History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.
* Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by Investigator.
* Presenting with immune suppression (e.g. autoimmune disease, HIV), as assessed by Investigator.
* Has undergone surgery in the last 3 months, or has surgery planned during the trial period, as assessed by Investigator.
* Uses concomitant medications including natural health products (excluding contraceptives and PRN or other medications, which in the Investigator's opinion, do not affect the trial outcomes or participant safety).
* Currently following a regimented or restricted diet which in the opinion of the Nutritionist and/or PI would negatively affect the study outcome or participants' ability to comply with study requirements, or has in the 3 months prior to enrollment.
* Plans to change dietary habits and/or activity level during the trial period.
* Frequent consumption of alcohol (\> 2 standard servings of alcohol/day on average).
* History of (assessed by PI) or current tobacco use (verified by positive cotinine urinalysis)
* Positive urinalysis for drugs of abuse (amphetamines, Cannabinoids, Cocaine and Opiates)
* Presenting a niacin deficiency, as assessed by Nutritionist's dietary assessment at screening, and Investigator's physical examination.
* Has difficulty swallowing capsules.
* Inability to provide blood and/or urine samples.
* Positive pregnancy test, intent to get pregnant, or breastfeeding.
* Any other condition that, in the opinion of the Investigator, could impair the Investigator's ability to complete the study outcomes and participant safety. Participating simultaneously in another clinical research protocol or having participated in another research study for which the exclusion period would not be completed
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04910061
Study Brief:
Protocol Section:
NCT04910061