2021 PMT iAge® Intervention Trial by Edifice Health

NCT04983017 | Terminated

• 1 other identifier: EH_21_01_PMT_iAge_INT
• Study Type: interventional
• Target: 781
• Locations: 1 country
• Sites: 2

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®).

Conditions

Chronic Inflammation; Inflammaging

Keywords

inflammatory age (iAge®); immunosenescence; immune phenotyping; systemic chronic inflammation

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (7)

• Change in immune protein biomarkers from Baseline to end of study intervention

  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

  Measured at Baseline, Day 50, Day 120 and Day 210

• Anthropometric and metabolic measurements from Baseline to end of study intervention

  Measured at Baseline, Day 50, Day 120 and Day 210

• Change in cardiovascular health from Baseline to end of study intervention

  Measured at Baseline, Day 50, Day 120 and Day 210

• Correlation of iAge score with ankle bone density score

  Measured at a single time point during the duration of the study

Other Outcomes (7)

• Track fitness performance biometrics from Baseline to end of study intervention

  Measured at Baseline, Day 50, Day 120 and Day 210

• Assessment of skin and scalp health from Baseline to end of study intervention

  Measured at Baseline, Day 50, Day 120 and Day 210

• Saliva sample collection

  Measured at Baseline in a subset of participants

Study Arms (2)

Dietary supplements

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo-matched formulations

Other: Placebo

Interventions

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

Dietary supplements

Placebo OTHER

Matched Placebo to Intervention

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

Sponsors & Collaborators

• Edifice Health: lead

Study Sites (2)

La Follette Ob-Gyn & Aesthetics

Greenbrae, California, 94904, United States

Location

Herman Clinical Research, LLC

Suwanee, Georgia, 30024, United States

Location

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MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Furman, PhD

  Chairman of the Scientific Advisory Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN

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

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 30, 2021
• Study Start: August 10, 2021
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)