AgingPhase 2NCT05296993
Safety & Efficacy of Extended Longevity Protocol
A Phase 2 study testing Extracts found in the Extended Longevity supplements in people with Aging, run by TruDiagnostic at 1 site in United States.
Trial summary
The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Extracts found in the Extended Longevity supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 8 Men and 7 Women
- Must between 55-75 years old
- Patient must be able to comply with treatment plan and laboratory tests
- Patients must have adequate immune system function, with no known immunodeficiency disease
Who cannot join
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- No immune system issues or immunodeficiency disease
- No 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
- Patients infected with hepatitis, C or HIV
Show all 10Show fewer
- Patients with Body Mass Index (BMI) > 40 kg/m2
- Presence of active infection
- Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
- Unable or unwilling to provide required blood sample for testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Quantum Functional Medicine
Carlsbad, California, 92008
About this study
Official title: The Safety and Effectiveness of the Extended Longevity Protocol on the Epigenetic Aging Rate in Healthy Individuals
The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age.
Read the detailed description
This is a prospective non-randomized clinical study of 15 patients to determine if the safety and effectiveness of the Extended Longevity Protocol's impact on the nine determinant factors of aging can decelerate aging.
There is evidence that the Extended Longevity Protocol decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of the Extended Longevity Protocol as an effective treatment option to improve clinical care of healthy individual's biological age thus prolonging longevity.
- Conditions
- Aging
- Being tested
- Extracts found in the Extended Longevity supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracts found in the Extended Longevity supplementsDietary supplement
Ingredients found in these serums are all naturally occurring, and extracted from a variety of plant species.
| Study group | Role | What they receive |
|---|---|---|
| Extracts | Experimental | The ingredients found in these serums are all naturally occurring ingredients extracted from a variety of plant species: Pinetonal, Thyvolve, Telogenic, Sentophagy, Inflasolve, Stemegenis, and CMEnhance Receives: Dietary Supplement: Extracts found in the Extended Longevity supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age
Serum epigenetic aging test
Measured: Testing will compare the change in results from baseline to 3 months
Epigenetic Age
serum epigenetic aging test
Measured: Testing will compare the change in results after completion of intervention with baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start25 May 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296993
- Sponsor's protocol ID
- TD-EL-001
- Status last verified
- May 2022
- First submitted
- 4 Mar 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of the Extended Longevity Protocol on the Epigenetic Aging Rate in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05296993
- Acronym / sponsor ID
- TD-EL-001
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Mar 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.
The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age.
Detailed description
This is a prospective non-randomized clinical study of 15 patients to determine if the safety and effectiveness of the Extended Longevity Protocol's impact on the nine determinant factors of aging can decelerate aging.
There is evidence that the Extended Longevity Protocol decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of the Extended Longevity Protocol as an effective treatment option to improve clinical care of healthy individual's biological age thus prolonging longevity.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracts | Experimental | Dietary Supplement: Extracts found in the Extended Longevity supplementsThe ingredients found in these serums are all naturally occurring ingredients extracted from a variety of plant species: Pinetonal, Thyvolve, Telogenic, Sentophagy, Inflasolve, Stemegenis, and CMEnhance |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 8 Men and 7 Women
- Must between 55-75 years old
- Patient must be able to comply with treatment plan and laboratory tests
- Patients must have adequate immune system function, with no known immunodeficiency disease
Key exclusion criteria (10 listed)
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- No immune system issues or immunodeficiency disease
- No 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 |
|---|---|---|
| Extracts found in the Extended Longevity supplementsIngredients found in these serums are all naturally occurring, and extracted from a variety of plant species. | Dietary supplement | Extracts |
Primary outcome
Epigenetic Age
Time frame: Testing will compare the change in results from baseline to 3 months
Serum epigenetic aging test
Epigenetic Age
Time frame: Testing will compare the change in results after completion of intervention with baseline
serum epigenetic aging test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Extracts found in the Extended Longevity supplements 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 4 inclusion and 10 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 11 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age (time frame: Testing will compare the change in results from baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2022.