AgingPhase 2NCT05310123
AC-11 Supplement and Biological Aging
A Phase 2 study testing AC-11 in people with Aging, run by TruDiagnostic at 1 site in United States.
Trial summary
This is a prospective non-randomized clinical study of 24 patients to evaluate the effects of the AC-11®. The study will evaluate the effectiveness of the supplement's ability to reverse epigenetic markers of biological age. The duration of the study will be 6 months. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- AC-11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women of any ethnicity.
- Age Range 55 years and older
- The patient must be able to comply with the treatment plan and laboratory tests
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)
- Diagnosis of a transient ischemic attack in the 6 months prior to screening
- Patients infected with hepatitis C or HIV
Show all 12Show 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 a required blood sample for testing
- As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
- If the patient has previously used AM/PM HealthSpan system supplements at any time before the start of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of AC-11® Supplementation in Reversing Epigenetic Markers of Biological Aging Including Those Related to Telomere Length
This is a prospective non-randomized clinical study of 24 patients to evaluate the effects of the AC-11®. The study will evaluate the effectiveness of the supplement's ability to reverse epigenetic markers of biological age. The duration of the study will be 6 months.
- Conditions
- Aging
- Being tested
- AC-11
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-11Dietary supplement
6-months of treatment with AC-11
| Study group | Role | What they receive |
|---|---|---|
| AC-11 | Experimental | 6 months of treatment with AC-11 Receives: Dietary Supplement: AC-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation age clock testing
Epigenetic testing
Measured: Change in epigenetic age from baseline to 6 months
Telomere Test
Epigenetic testing
Measured: Change in telomere length from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start26 May 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, non-randomized
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optigenex, Inc
- Responsible party
- Sponsor
- Investigators
- Phillip Gallegos, Principal investigator, Thrive Medicine Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310123
- Sponsor's protocol ID
- OI-AC11-001
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guthrie OW, Xu H. Reduced Phosphorylation of Histone Variant H2Ax in the Organ Of Corti Is Associated With Otoprotection from Noise Injury. Otolaryngology 2013; 3:131.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of AC-11® Supplementation in Reversing Epigenetic Markers of Biological Aging Including Those Related to Telomere Length
- ClinicalTrials.gov ID
- NCT05310123
- Acronym / sponsor ID
- OI-AC11-001
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Collaborators
- Optigenex, Inc
- Study start
- 26 May 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 4 Apr 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.
This is a prospective non-randomized clinical study of 24 patients to evaluate the effects of the AC-11®. The study will evaluate the effectiveness of the supplement's ability to reverse epigenetic markers of biological age. The duration of the study will be 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, non-randomized
| Arm | Type | Receives |
|---|---|---|
| AC-11 | Experimental | Dietary Supplement: AC-116 months of treatment with AC-11 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women of any ethnicity.
- Age Range 55 years and older
- The patient must be able to comply with the treatment plan and laboratory tests
Key exclusion criteria (12 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)
- 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 |
|---|---|---|
| AC-116-months of treatment with AC-11 | Dietary supplement | AC-11 |
Primary outcome
Methylation age clock testing
Time frame: Change in epigenetic age from baseline to 6 months
Epigenetic testing
Telomere Test
Time frame: Change in telomere length from baseline to 6 months
Epigenetic testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- BackgroundGuthrie OW, Xu H. Reduced Phosphorylation of Histone Variant H2Ax in the Organ Of Corti Is Associated With Otoprotection from Noise Injury. Otolaryngology 2013; 3:131.
- Individual participant dataSharing planned: No
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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.
Phillip Gallegos principal investigator
Thrive Medicine Clinic
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 AC-11 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 3 inclusion and 12 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 Apr 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?
Methylation age clock testing (time frame: Change in epigenetic age from baseline to 6 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?
On the ClinicalTrials.gov record for NCT05310123, which also lists 1 linked publication.
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 Apr 2022.