Targeting the Nine Hallmarks of Aging on DNA Methylation

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535608
• Other study ID #: 10349
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: TruDiagnostic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• SRW Cel System
Dietary supplement

Locations

Country	Name	City	State
United States	Regenerative Wellness Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
TruDiagnostic	SRW

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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