2021 PMT iAge® Intervention Trial by Edifice Health

September 17, 2024 updated by: Lizellen La Follette, MD, Edifice Health

Randomized, Double-Blinded, Placebo-Controlled Study With Immunotype Specific Dietary Supplements to Improve Inflammatory Age® by Edifice Health

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®).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This decentralized, double-blind, randomized, placebo-controlled study will identify interventions that may lower a participant's inflammatory age (iAge®) and will increase the number of participants with objective and subjective health information that have associated iAge® scores. The study will also (1) correlate secondary endpoints with baseline and subsequent iAge® scores, (2) confirm the compatibility of the iAge® test with the Tasso device, ADX100 or ViveBio home blood collection systems, and (3) confirm the compatibility of the iAge® test with saliva home sample collection kit.

Ambulatory adults, 18 years old and over of diverse ethnicities will be invited to participate in this study from a single site in Marin County. We will choose an equal number of male and female participants by selecting households within a 60 mile radius of the study site.

The study involves fasting blood sample collection to measure and characterize immunomes and inflammatory biomarkers, metabolites, lipid panel, hemoglobin, hemoglobin A1C, and high-sensitivity c-reactive protein (hsCRP). Participants will be asked to provide a blood sample by routine venipuncture at Baseline and approximately 2, 4 and 7 months after the start of the dietary supplement/placebo.

Participants will be given interventions to be taken daily based on their associated immunogroup cluster after each iAge® test is completed. Participants can continue on their current supplements but should not start any new supplements except those given by the study. This study has a different intervention for nine of the ten immunotype clusters. All interventions are i) generally recognized as safe (GRAS) or ii) from compounds at similar concentrations to those found in foods. Participants will be placed in one of ten immunotype clusters after each iAge® test and randomized either to a placebo or the given formulation to be taken once daily (either one, two or three pills depending on the formulation). A participant who changes his/her immunotype cluster after a follow up iAge® test will be given a new dietary intervention (or placebo based on their previous category).

All participants will also be given a Whoop wearable watch to collect information on strain, sleep and heart rate variability. Participants will be asked to complete questionnaires assessing mood, stress level, well-being, cognition, health and lifestyle. We will also obtain the following measurements: (1) Height and weight, (2) blood pressure, (3) waist and hip measurements, (4) pulse wave velocity (PWV) to measure arterial stiffness (5) timed up and go to assess frailty and (6) facial and scalp photos.

A gut microbiome sampling using a third party kit for fecal collection will be obtained at each designated time point from those participants who agree to have fecal sample collection. A subset of participants will have the following procedures done at any time point during the study: (1) saliva collection, (2) heel bone density, (3) audiometry test, (4) home blood sample collection using the Tasso device, ADX100, and ViveBio device.

Study Type

Interventional

Enrollment (Actual)

781

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Greenbrae, California, United States, 94904
        • La Follette Ob-Gyn & Aesthetics
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Herman Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dietary supplements
Dietary supplements are either (1) designated as Generally Recognized As Safe (GRAS) by the Food and Drug Administration or (2) compounds at similar concentrations to those found in foods.
Dietary supplement: Dietary supplement
iron bisglycinate manganese chloride vitamin D2 guar gum indole-3-carbinol L-methionine piceatannol biotin caffeine beta-carotene lutein zinc sulfate
Placebo Comparator: Placebo
Placebo-matched formulations
Other: Placebo
Matched Placebo to Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory age (iAge®) scores from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Measurement of iAge® scores in all study participants. Peripheral blood samples will be collected, processed and analyzed and iAge is measured using standardized procedures, immune phenotyping and artificial intelligence algorithms.
Measured at Baseline, Day 50, Day 120 and Day 210

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in immune protein biomarkers from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Blood sample measurements of the levels of the biomarkers Eotaxin-1 (CCL11), Interferon-gamma, Growth Regulated Oncogene-alpha, Monokine Induced by Gamma Interferon (MIG) and TNF-related Apoptosis Inducing Ligand (TRAIL)
Measured at Baseline, Day 50, Day 120 and Day 210
Change in values for hemoglobin, A1C, high sensitivity C-reactive protein (hs-CRP), and lipid panel from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Blood samples measured for hemoglobin, A1C, hs-CRP, and lipid panel
Measured at Baseline, Day 50, Day 120 and Day 210
Anthropometric and metabolic measurements from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Measurement of height, weight, body mass index (BMI), waist-to-hip ratio
Measured at Baseline, Day 50, Day 120 and Day 210
Change in cardiovascular health from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Measurement of blood pressure, pulse wave velocity using the Whithings Cardio device and heart rate variability with the Whoop wearable
Measured at Baseline, Day 50, Day 120 and Day 210
Correlation of iAge score with ankle bone density score
Time Frame: Measured at a single time point during the duration of the study
Measurement of ankle bone density using the GE Achilles Lunar Express ultrasonometer
Measured at a single time point during the duration of the study
Correlation of iAge score with hearing test score
Time Frame: Measured at a single time point during the duration of the study
Measurement of hearing acuity using the Shoebox Audiometry System
Measured at a single time point during the duration of the study
Change in frailty and mobility from Baseline to end of study intervention
Time Frame: Measured at Baseline and Day 210
Timed Up and Go (TUG) test will be use to measure the length of time in seconds it takes for the participant to stand from a chair, walk 3 meters, turn around and sit back in the chair. TUG is a simple sensitive test to assess mobility, balance, walking ability, and fall risk in older adults.
Measured at Baseline and Day 210

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Track fitness performance biometrics from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Measurement and monitoring of sleep, strain, and heart rate variability using the WHOOP wearable device
Measured at Baseline, Day 50, Day 120 and Day 210
Assessment of skin and scalp health from Baseline to end of study intervention
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210
Facial and scalp photos will be taken using an iPAD
Measured at Baseline, Day 50, Day 120 and Day 210
Saliva sample collection
Time Frame: Measured at Baseline in a subset of participants
General and oral health assessment through saliva sample collection in a subset of participants
Measured at Baseline in a subset of participants
Changes in the gut microbiome at Baseline to end of study intervention in a subset of participants
Time Frame: Measured at a single time point during the duration of the study in a subset of participants
Evaluate changes in the gut microbiome using the Thryve Gut Health Test Kit to collect stool samples
Measured at a single time point during the duration of the study in a subset of participants
Correlation of standard venipuncture with at-home Tasso, ADX100m and ViveBio collection system in predicting iAge
Time Frame: Measured at Baseline in a subset of participants
Capillary blood collection using the at-home Tasso, ADX100 and ViveBio collection system in a subset of study participants
Measured at Baseline in a subset of participants
Changes in metabolomic profile
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants
In a subset of participants, metabolite analysis of blood plasma using high-throughput technology
Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants
Skin pH
Time Frame: Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants
Skin pH probe
Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edifice Health

Investigators

  • Principal Investigator: David Furman, PhD, Chairman of the Scientific Advisory Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2021

Primary Completion (Actual)

September 9, 2022

Study Completion (Actual)

September 9, 2022

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH_21_01_PMT_iAge_INT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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