Targeting the Nine Hallmarks of Aging on DNA Methylation

Sponsor
TruDiagnostic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05535608
Collaborator
SRW (Other)
50
1
1
16.5
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: SRW Cel System
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Impact of a Natural Ingredients and App Based Intervention Targeting the Nine Hallmarks of Aging on DNA Methylation
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Biological age [Change in epigenetic age from baseline to 12 months]

    The primary outcome measure for the study is biological age, measured by DNA methylation, using blood and saliva samples collected from patients.

Secondary Outcome Measures

  1. Inflammatory marker IL-6 [Change in inflammatory marker from baseline to 12 months]

    (IL-6 will also be assessed at 3, 6, and 12 months.

  2. C-reactive protein [Change in inflammatory marker from baseline to 12 months]

    C-reactive protein will also be assessed at 3, 6, and 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regenerative Wellness Center Salt Lake City Utah United States 84117

Sponsors and Collaborators

  • TruDiagnostic
  • SRW

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
TruDiagnostic
ClinicalTrials.gov Identifier:
NCT05535608
Other Study ID Numbers:
  • 10349
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 10, 2022