AgingPhase 2NCT05535608
Targeting the Nine Hallmarks of Aging on DNA Methylation
A Phase 2 study testing SRW Cel System in people with Aging, run by TruDiagnostic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- SRW Cel System
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Regenerative Wellness Center
Salt Lake City, Utah, 84117
Lisa Sanders, 801-797-5901, info@regwellness.com
Daniel Garcia, 8017975901, info@regwellness.com
About this study
Official title: The Impact of a Natural Ingredients and App Based Intervention Targeting the Nine Hallmarks of Aging on DNA Methylation
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.
Read the 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.
- Conditions
- Aging
- Being tested
- SRW Cel System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRW Cel SystemDietary supplement
Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: SRW Cel System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological age
The primary outcome measure for the study is biological age, measured by DNA methylation, using blood and saliva samples collected from patients.
Measured: Change in epigenetic age from baseline to 12 months
Secondary outcomes (2)
Inflammatory marker IL-6
(IL-6 will also be assessed at 3, 6, and 12 months.
Measured: Change in inflammatory marker from baseline to 12 months
C-reactive protein
C-reactive protein will also be assessed at 3, 6, and 12 months.
Measured: Change in inflammatory marker from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start15 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SRW
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535608
- Sponsor's protocol ID
- 10349
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35358003Bungau 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.
PubMed 33919088Gonzales 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.
PubMed 35098970Hong 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.
PubMed 32411700Hassan 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.
PubMed 31214247
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Natural Ingredients and App Based Intervention Targeting the Nine Hallmarks of Aging on DNA Methylation
- ClinicalTrials.gov ID
- NCT05535608
- Acronym / sponsor ID
- 10349
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Collaborators
- SRW
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRW Cel system | Experimental | Dietary Supplement: SRW Cel SystemCel1, Cel2, Cel3 Patients will take all three supplements once daily. Patients will take 2 capsules of each supplement in the morning with food. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRW Cel SystemDietary supplement | Dietary supplement | SRW Cel system |
Primary outcome
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.
2 secondary outcomes
Inflammatory marker IL-6
Time frame: Change in inflammatory marker from baseline to 12 months
C-reactive protein
Time frame: Change in inflammatory marker from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 35358003Blagosklonny 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.
- Background: PubMed 33919088Bungau 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.
- Background: PubMed 35098970Gonzales 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.
- Background: PubMed 32411700Hong 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.
- Background: PubMed 31214247Hassan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SRW Cel System in people with Aging, run by TruDiagnostic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological age (time frame: Change in epigenetic age from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535608, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.