2021 PMT iAge® Intervention Trial by Edifice Health

Sponsor

Edifice Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04983017

Collaborator

(none)

750

Enrollment

Locations

Arms

11.7

Anticipated Duration (Months)

375

Patients Per Site

32.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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®).

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammation Inflammaging	Dietary Supplement: Dietary supplement Other: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Participants will receive a formulation of dietary supplements based on the iAge test. Different formulations contain different combinations of dietary supplements.Participants will receive a formulation of dietary supplements based on the iAge test. Different formulations contain different combinations of dietary supplements.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 10, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in immune protein biomarkers from Baseline to end of study intervention [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)
Change in values for hemoglobin, A1C, high sensitivity C-reactive protein (hs-CRP), and lipid panel from Baseline to end of study intervention [Measured at Baseline, Day 50, Day 120 and Day 210]
Blood samples measured for hemoglobin, A1C, hs-CRP, and lipid panel
Anthropometric and metabolic measurements from Baseline to end of study intervention [Measured at Baseline, Day 50, Day 120 and Day 210]
Measurement of height, weight, body mass index (BMI), waist-to-hip ratio
Change in cardiovascular health from Baseline to end of study intervention [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
Correlation of iAge score with ankle bone density score [Measured at a single time point during the duration of the study]
Measurement of ankle bone density using the GE Achilles Lunar Express ultrasonometer
Correlation of iAge score with hearing test score [Measured at a single time point during the duration of the study]
Measurement of hearing acuity using the Shoebox Audiometry System
Change in frailty and mobility from Baseline to end of study intervention [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.

Other Outcome Measures

Track fitness performance biometrics from Baseline to end of study intervention [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
Assessment of skin and scalp health from Baseline to end of study intervention [Measured at Baseline, Day 50, Day 120 and Day 210]
Facial and scalp photos will be taken using an iPAD
Saliva sample collection [Measured at Baseline in a subset of participants]
General and oral health assessment through saliva sample collection in a subset of participants
Changes in the gut microbiome at Baseline to end of study intervention in a subset of participants [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
Correlation of standard venipuncture with at-home Tasso, ADX100m and ViveBio collection system in predicting iAge [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
Changes in metabolomic profile [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
Skin pH [Measured at Baseline, Day 50, Day 120 and Day 210 in a subset of participants]
Skin pH probe

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	La Follette Ob-Gyn & Aesthetics	Greenbrae	California	United States	94904
2	Herman Clinical Research, LLC	Suwanee	Georgia	United States	30024

Sponsors and Collaborators

Edifice Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Lizellen La Follette, MD, OBGYN, Edifice Health

ClinicalTrials.gov Identifier:

NCT04983017

Other Study ID Numbers:

EH_21_01_PMT_iAge_INT

First Posted:

Jul 30, 2021

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lizellen La Follette, MD, OBGYN, Edifice Health

inflammatory age (iAge®)

immunosenescence

immune phenotyping

systemic chronic inflammation

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Jun 10, 2022