AC-11 Supplement and Biological Aging

NCT05310123 | Unknown Phase 2

• 1 other identifier: OI-AC11-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

AC-11

EXPERIMENTAL

6 months of treatment with AC-11

Dietary Supplement: AC-11

Interventions

AC-11 DIETARY_SUPPLEMENT

6-months of treatment with AC-11

AC-11

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TruDiagnostic: lead
• Optigenex, Inc: collaborator

Study Sites (1)

Thrive Medicine Clinic

Sugar Land, Texas, 77478, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

Study Officials

• Phillip Gallegos

  Thrive Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, non-randomized

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 4, 2022
• Study Start: May 26, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)