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Chronic InflammationNCT04983017

2021 PMT iAge® Intervention Trial by Edifice Health

A study testing Dietary supplement in people with Chronic Inflammation and Inflammaging, run by Edifice Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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®). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Inflammation, Inflammaging
What is being tested?
Dietary supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
781 participants
Where
2 sitesUnited States
Study dates
10 Aug 2021to 9 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18+ years old
  • Ambulatory
  • Willing and able to comply with the study protocol

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • La Follette Ob-Gyn & Aesthetics

    Greenbrae, California, 94904

  • Herman Clinical Research, LLC

    Suwanee, Georgia, 30024

Other trials in United States

About this study

Official title: 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®).

Read the 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.

Being tested
Dietary supplement, Placebo
Keywords
inflammatory age (iAge®), immunosenescence, immune phenotyping, systemic chronic inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary supplementDietary supplement

    iron bisglycinate manganese chloride vitamin D2 guar gum indole-3-carbinol L-methionine piceatannol biotin caffeine beta-carotene lutein zinc sulfate

  • PlaceboOther

    Matched Placebo to Intervention

Study groups in NCT04983017
Study groupRoleWhat they receive
Dietary supplementsActive comparatorDietary 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.
Receives: Dietary Supplement: Dietary supplement
PlaceboPlacebo comparatorPlacebo-matched formulations
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

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

  2. Change in values for hemoglobin, A1C, high sensitivity C-reactive protein (hs-CRP), and lipid panel from Baseline to end of study intervention

    Blood samples measured for hemoglobin, A1C, hs-CRP, and lipid panel

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

  3. Anthropometric and metabolic measurements from Baseline to end of study intervention

    Measurement of height, weight, body mass index (BMI), waist-to-hip ratio

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

  4. Change in cardiovascular health from Baseline to end of study intervention

    Measurement of blood pressure, pulse wave velocity using the Whithings Cardio device and heart rate variability with the Whoop wearable

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

  5. Correlation of iAge score with ankle bone density score

    Measurement of ankle bone density using the GE Achilles Lunar Express ultrasonometer

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

  6. Correlation of iAge score with hearing test score

    Measurement of hearing acuity using the Shoebox Audiometry System

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

  7. Change in frailty and mobility from Baseline to end of study intervention

    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: Measured at Baseline and Day 210

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start10 Aug 2021
  3. Primary completion9 Sep 2022
  4. Study completion9 Sep 2022

Why it stopped: There was no significant difference between placebo and control.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Model description
Participants will receive a formulation of dietary supplements based on the iAge test. Different formulations contain different combinations of dietary supplements.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
781 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983017
Sponsor's protocol ID
EH_21_01_PMT_iAge_INT
Status last verified
Sep 2024
First submitted
26 Jul 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Veselkov K, Gonzalez G, Aljifri S, Galea D, Mirnezami R, Youssef J, Bronstein M, Laponogov I. HyperFoods: Machine intelligent mapping of cancer-beating molecules in foods. Sci Rep. 2019 Jul 3;9(1):9237. doi: 10.1038/s41598-019-45349-y.

    PubMed 31270435

  • Woo G, Fernandez M, Hsing M, Lack NA, Cavga AD, Cherkasov A. DeepCOP: deep learning-based approach to predict gene regulating effects of small molecules. Bioinformatics. 2020 Feb 1;36(3):813-818. doi: 10.1093/bioinformatics/btz645.

    PubMed 31504186

  • BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

    PubMed 13688369

  • Damin AE, Nitrini R, Brucki SMD. Cognitive Change Questionnaire as a method for cognitive impairment screening. Dement Neuropsychol. 2015 Jul-Sep;9(3):237-244. doi: 10.1590/1980-57642015DN93000005.

    PubMed 29213967

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865

  • Sayed N, Gao T, Ribshirani R, Hastie T, Cui L, Kuznetsova T, Rosenberg-Hasson Y, Ostan R, Monti D, Lehallier B, Shen-Orr S, Maecker HT, Dekker CL, Wyss-Coray T, Franceschi , Jojic V, Haddad F, Montoya JG, Wu JC and Furman D. An Inflammatory Clock Predicts Multi-morbidity, Immunosenescence and Cardiovascular Aging in Humans. (2019) bioRxiv 840363; doi: https://doi.org/10.1101/840363

  • Bradley, C. L. A. R. E. The well-being questionnaire. Chur, Switzerland, Harwood Academic Publishers, 1994.

  • Fung EB, Kwiatkowski JL, Huang JN, Gildengorin G, King JC, Vichinsky EP. Zinc supplementation improves bone density in patients with thalassemia: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Oct;98(4):960-71. doi: 10.3945/ajcn.112.049221. Epub 2013 Aug 14.

    PubMed 23945720

  • Awad A, Zaglool AW, Ahmed SAA, Khalil SR. Transcriptomic profile change, immunological response and disease resistance of Oreochromis niloticus fed with conventional and Nano-Zinc oxide dietary supplements. Fish Shellfish Immunol. 2019 Oct;93:336-343. doi: 10.1016/j.fsi.2019.07.067. Epub 2019 Jul 25.

    PubMed 31352117

  • Guzman-Rivero M, Verduguez-Orellana A, Montano K, Cloetens L, Rojas E, Akesson B, Sejas E. The immune response in patients with cutaneous leishmaniasis and the influence of zinc supplementation. Biomed Pharmacother. 2015 Feb;69:56-62. doi: 10.1016/j.biopha.2014.11.006. Epub 2014 Nov 15.

    PubMed 25661338

  • Green JA, Lewin SR, Wightman F, Lee M, Ravindran TS, Paton NI. A randomised controlled trial of oral zinc on the immune response to tuberculosis in HIV-infected patients. Int J Tuberc Lung Dis. 2005 Dec;9(12):1378-84.

    PubMed 16466061

  • Guzman-Rivero, M., Verduguez-Orellana, A., Cordova, M., Maldonado, L., Medina, M., Sejas, E., & Åkesson, B. (2014). Effect of zinc on immune functions in patients with pulmonary tuberculosis. Biomedicine & Preventive Nutrition, 4(2), 245-250.

  • Acevedo-Murillo JA, Garcia Leon ML, Firo-Reyes V, Santiago-Cordova JL, Gonzalez-Rodriguez AP, Wong-Chew RM. Zinc Supplementation Promotes a Th1 Response and Improves Clinical Symptoms in Fewer Hours in Children With Pneumonia Younger Than 5 Years Old. A Randomized Controlled Clinical Trial. Front Pediatr. 2019 Nov 14;7:431. doi: 10.3389/fped.2019.00431. eCollection 2019.

    PubMed 31803694

  • Ranasinghe P, Wathurapatha WS, Ishara MH, Jayawardana R, Galappatthy P, Katulanda P, Constantine GR. Effects of Zinc supplementation on serum lipids: a systematic review and meta-analysis. Nutr Metab (Lond). 2015 Aug 4;12:26. doi: 10.1186/s12986-015-0023-4. eCollection 2015.

    PubMed 26244049

  • Rosenkranz E, Hilgers RD, Uciechowski P, Petersen A, Plumakers B, Rink L. Zinc enhances the number of regulatory T cells in allergen-stimulated cells from atopic subjects. Eur J Nutr. 2017 Mar;56(2):557-567. doi: 10.1007/s00394-015-1100-1. Epub 2015 Nov 20.

    PubMed 26589301

Questions about this trial

What is this clinical trial studying?

A study testing Dietary supplement in people with Chronic Inflammation and Inflammaging, run by Edifice Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: There was no significant difference between placebo and control.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983017, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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