2021 PMT iAge® Intervention Trial by Edifice Health
Stopped early · Not applicable · Has a placebo group
Conditions studied: Chronic Inflammation, Inflammaging
In brief
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®).
Key facts
- Study ID
- NCT04983017
- Run by
- Edifice Health
- People needed
- 781
- Starts
- 2021-08-10
- Expected to finish
- 2022-09-09
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18+ years old
- Ambulatory
- Willing and able to comply with the study protocol
You may not qualify if…
- 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 dycrasias or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anticoagulation medication
- A medical or psychiatric condition or occupational responsibilities that would preclude subject compliance with the protocol
- History of Guillain-Barre syndrome
Where it is running
- La Follette Ob-Gyn & Aesthetics — Greenbrae, California, United States
- Herman Clinical Research, LLC — Suwanee, Georgia, United States
Full record on ClinicalTrials.gov
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