Targeting the Nine Hallmarks of Aging on DNA Methylation

NCT05535608 | Unknown Phase 2

• 1 other identifier: 10349
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Inflammatory marker IL-6

  Change in inflammatory marker from baseline to 12 months

• C-reactive protein

  Change in inflammatory marker from baseline to 12 months

Study Arms (1)

SRW Cel system

EXPERIMENTAL

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

Interventions

SRW Cel System DIETARY_SUPPLEMENT

Dietary supplement

SRW Cel system

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of any ethnicity
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TruDiagnostic: lead
• SRW: collaborator

Study Sites (1)

Regenerative Wellness Center

Salt Lake City, Utah, 84117, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 35358003 BACKGROUND

• 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):2407. doi: 10.3390/molecules26092407.

  PMID: 33919088 BACKGROUND

• 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.

  PMID: 35098970 BACKGROUND

• 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.

  PMID: 32411700 BACKGROUND

• 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.

  PMID: 31214247 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: August 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

US (1)