2021 PMT iAge® Intervention Trial by Edifice Health (NCT04983017) | Clinical Trial Compass
TerminatedNot Applicable
2021 PMT iAge® Intervention Trial by Edifice Health
Stopped: There was no significant difference between placebo and control.
United States781 participantsStarted 2021-08-10
Plain-language summary
This is a decentralized, double-blind, randomized, placebo-controlled study to assess the effectiveness of different dietary supplements in decreasing systemic chronic inflammation (SCI) and lowering inflammatory age (iAge®). iAge® is a metric for age-related chronic inflammation and immune function decline calculated from a standard blood draw utilizing immune phenotyping and artificial intelligence algorithms. SCI is a natural process that occurs within the body. It is believed to accelerate the process of biological aging. As opposed to acute inflammation, iAge® is not a reflection of illness, infection, trauma or injury. It naturally occurs in the ambulatory healthy population as we age as a function of the body.
This study will use immunotype specific dietary supplement formulations to improve a participant's Inflammatory Age® (iAge®).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18+ years old
* Ambulatory
* Willing and able to comply with the study protocol
Exclusion Criteria:
* Participants with any condition that may preclude venipuncture or venous blood draws will be excluded.
* Participants with known allergies to interventions will be removed from the study.
* Vulnerable subjects including children, employees and those with cognitive disabilities will not be included in this study.
* Male participants on iron supplementation
* Participants on \>1 mg manganese, \>5 mg biotin
* Pregnant women
* Nursing women
* Membership in the clinical study team
* Any condition that might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol
At the time of enrollment:
* Active systemic or serious concurrent illness
* History of immunodeficiency
* Any known or suspected impairment of immunologic function
* Diabetes mellitus treated with any diabetic medication
* Moderate to severe renal disease
* Blood pressure greater than 140/90
* Chronic hepatitis B or C
* Recent or current use of immunosuppressive medication
* Malignancy other than squamous cell or basal cell skin cancer, including solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia, which might jeopardize volunteer safety or compliance with the protocol
* Autoimmune disease
* Auto-inflammatory disease
* History of blood dycras…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in inflammatory age (iAge®) scores from Baseline to end of study intervention
Timeframe: Measured at Baseline, Day 50, Day 120 and Day 210