Targeting the Nine Hallmarks of Aging on DNA Methylation

NCT ID: NCT05535608

Last Updated: 2022-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SRW Cel System

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement

Interventions

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SRW Cel System

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SRW

UNKNOWN

Sponsor Role collaborator

TruDiagnostic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regenerative Wellness Center

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Lisa Sanders

Role: primary

801-797-5901

Daniel Garcia

Role: backup

8017975901

References

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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.

Reference Type BACKGROUND
PMID: 35358003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33919088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35098970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32411700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31214247 (View on PubMed)

Other Identifiers

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10349

Identifier Type: -

Identifier Source: org_study_id

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