AC-11 Supplement and Biological Aging

Aging Clinical Trial

Official title:

Investigation of AC-11® Supplementation in Reversing Epigenetic Markers of Biological Aging Including Those Related to Telomere Length

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05310123
• Other study ID #: OI-AC11-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 26, 2021
• Est. completion date: October 2022

Study information

• Verified date: April 2022
• Source: TruDiagnostic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Men and women of any ethnicity.

2. Age Range 55 years and older

3. The patient must be able to comply with the treatment plan and laboratory tests

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision

2. No immune system issues or immunodeficiency disease

3. No history of viral illness which could be reactivated by immune downregulation

4. Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)

5. Diagnosis of a transient ischemic attack in the 6 months prior to screening

6. Patients infected with hepatitis C or HIV

7. Patients with Body Mass Index (BMI) > 40 kg/m2

8. Presence of active infection

9. 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

10. Unable or unwilling to provide a required blood sample for testing

11. As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.

12. If the patient has previously used AM/PM HealthSpan system supplements at any time before the start of the trial.

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• AC-11
6-months of treatment with AC-11

Locations

Country	Name	City	State
United States	Thrive Medicine Clinic	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
TruDiagnostic	Optigenex, Inc

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methylation age clock testing	Epigenetic testing	Change in epigenetic age from baseline to 6 months
Primary	Telomere Test	Epigenetic testing	Change in telomere length from baseline to 6 months