The Impact of a Natural Ingredients and App Based Intervention Targeting the Nine Hallmarks of Aging on DNA Methylation
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Biological age
Study Overview
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.
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
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 90 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: SRW Cel System (Dietary Supplement)
Outcomes
Primary Outcomes
Biological age
Time Frame: 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 Outcomes
- C-reactive protein(Change in inflammatory marker from baseline to 12 months)
- Inflammatory marker IL-6(Change in inflammatory marker from baseline to 12 months)