Targeting the Nine Hallmarks of Aging on DNA Methylation

The Impact of a Natural Ingredients and App Based Intervention Targeting the Nine Hallmarks of Aging on DNA Methylation

SRW Laboratories has formulated the Cel System protocol, a group of three formulas designed to interact with each of the 9 Hallmarks of Aging and combined this with an App that supports positive lifestyle changes, with a view that, if we can positively impact each Hallmark, we can support healthy aging.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: SRW Cel System

Detailed Description

This study will measure the impact of the Cel System protocol on the biological clocks of the participants, as well as measure established biomarkers associated with the 9 Hallmarks and note any aesthetic changes you may experience to establish evidence of the effect of the Cel System Protocol over time.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Recruiting
      • Regenerative Wellness Center
      • Contact: Lisa Sanders; Phone Number: 801-797-5901; Email: info@regwellness.com
      • Contact: Daniel Garcia; Phone Number: 8017975901; Email: info@regwellness.com
      • Principal Investigator: Steve Warren, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women of any ethnicity
• 55 years and older
• Female subjects must be post-menopausal
• Participant must be able to comply with treatment plan and laboratory tests
• Participant must be able to read, write, and speak English fluently
• Participant must have a smartphone and be able to download and use the App
• Participant must have an established primary care provider
• Participant must be willing and able to consume study supplements throughout the duration of study period

Exclusion Criteria:

• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Known immune system issues or immunodeficiency disease
• History of viral illness which could be reactivated by immune downregulation
• Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
• Diagnosis of a transient ischemic attack in the 6 months prior to screening
• Participants infected with hepatitis C or HIV
• Presence of active infection in previous 4 weeks
• Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the Clinical Investigator would render a participant unsuitable to participate in the study
• Unable or unwilling to provide required blood sample for testing
• Current or previous use of known prescription immunomodulating products (e.g. glucocorticoids, TNF-alpha inhibitors) in the month prior to the start of the trial.
• A known history of blood dyscrasias including coagulopathy
• Any person deemed by the Investigator as having a low likelihood of complying with study protocol (e.g. evidence of history of non-compliance, history of poor follow-up, multiple or complex scheduling conflicts).
• Planned surgical procedure during study period
• Participants who are actively engaged in a weight loss program or have started any new medications during the duration of the trial that can potentially interfere with the study, as deemed appropriate by Principal Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRW Cel system; Cel1, Cel2, Cel3 Patients will take all three supplements once daily. Patients will take 2 capsules of each supplement in the morning with food.	Dietary supplement: SRW Cel System; Dietary supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological age	The primary outcome measure for the study is biological age, measured by DNA methylation, using blood and saliva samples collected from patients.	Change in epigenetic age from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory marker IL-6	(IL-6 will also be assessed at 3, 6, and 12 months.	Change in inflammatory marker from baseline to 12 months
C-reactive protein	C-reactive protein will also be assessed at 3, 6, and 12 months.	Change in inflammatory marker from baseline to 12 months

Collaborators and Investigators

• Sponsor: TruDiagnostic
• Collaborators: SRW

Publications and helpful links

General Publications

• Blagosklonny MV. Cell senescence, rapamycin and hyperfunction theory of aging. Cell Cycle. 2022 Jul;21(14):1456-1467. doi: 10.1080/15384101.2022.2054636. Epub 2022 Mar 31. Review.
• Bungau S, Vesa CM, Abid A, Behl T, Tit DM, Purza AL, Pasca B, Todan LM, Endres L. Withaferin A-A Promising Phytochemical Compound with Multiple Results in Dermatological Diseases. Molecules. 2021 Apr 21;26(9). pii: 2407. doi: 10.3390/molecules26092407. Review.
• Gonzales MM, Garbarino VR, Marques Zilli E, Petersen RC, Kirkland JL, Tchkonia T, Musi N, Seshadri S, Craft S, Orr ME. Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD): A Pilot Clinical Trial. J Prev Alzheimers Dis. 2022;9(1):22-29. doi: 10.14283/jpad.2021.62.
• Hong W, Mo F, Zhang Z, Huang M, Wei X. Nicotinamide Mononucleotide: A Promising Molecule for Therapy of Diverse Diseases by Targeting NAD+ Metabolism. Front Cell Dev Biol. 2020 Apr 28;8:246. doi: 10.3389/fcell.2020.00246. eCollection 2020. Review.
• Hassan FU, Rehman MS, Khan MS, Ali MA, Javed A, Nawaz A, Yang C. Curcumin as an Alternative Epigenetic Modulator: Mechanism of Action and Potential Effects. Front Genet. 2019 Jun 4;10:514. doi: 10.3389/fgene.2019.00514. eCollection 2019. Review.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 10349 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No