AC-11 Supplement and Biological Aging

NCT ID: NCT05310123

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, non-randomized
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AC-11

6 months of treatment with AC-11

Group Type EXPERIMENTAL

AC-11

Intervention Type DIETARY_SUPPLEMENT

6-months of treatment with AC-11

Interventions

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AC-11

6-months of treatment with AC-11

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Optigenex, Inc

UNKNOWN

Sponsor Role collaborator

TruDiagnostic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phillip Gallegos

Role: PRINCIPAL_INVESTIGATOR

Thrive Medicine Clinic

Locations

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Thrive Medicine Clinic

Sugar Land, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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OI-AC11-001

Identifier Type: -

Identifier Source: org_study_id

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