AC-11 Supplement and Biological Aging | NCT05310123

Studies
AC-11 Supplement and Biological Aging

NCT05310123

Sponsor

TruDiagnostic

Status

Unknown status

Last Update Posted

Apr 11, 2022Actual

Enrollment

32Estimated

Phase

Phase 2

Conditions

Aging

Interventions

AC-11

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2021Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Mar 2, 2022

First Submission Date that Met QC Criteria

Mar 25, 2022

First Posted Date

Apr 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2022

Last Update Posted Date

Apr 11, 2022Actual

Name	Class
Optigenex, Inc	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AC-11	Experimental	6 months of treatment with AC-11	Dietary Supplement: AC-11

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AC-11	Dietary Supplement	6-months of treatment with AC-11	AC-11

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Methylation age clock testing	Epigenetic testing	Change in epigenetic age from baseline to 6 months
Telomere Test	Epigenetic testing	Change in telomere length from baseline to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Phillip Gallegos	Thrive Medicine Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Thrive Medicine Clinic		Sugar Land	Texas	77478	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.