Randomized, Double-Blinded, Placebo-Controlled Study With Immunotype Specific Dietary Supplements to Improve Inflammatory Age® by Edifice Health
Trial ID: NCT04983017
Status: TERMINATED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-08-10
Completion date: 2022-09-09
Sponsor: Edifice Health
Conditions: Chronic Inflammation; Inflammaging
Interventions: Dietary supplement; Placebo
Locations: La Follette Ob-Gyn & Aesthetics; Herman Clinical Research, LLC
Countries: United States; United States
Enrollment: 781
Age range: 18 Years - None
Sex: ALL

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®).

Eligibility criteria:
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 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

Outcomes:
Change in inflammatory age (iAge®) scores from Baseline to end of study intervention