Safety & Efficacy of Extended Longevity Protocol

Aging Clinical Trial

Official title:

The Safety and Effectiveness of the Extended Longevity Protocol on the Epigenetic Aging Rate in Healthy Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05296993
• Other study ID #: TD-EL-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 25, 2021
• Est. completion date: December 2023

Study information

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

Clinical Trial Summary

The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age.

Description:

This is a prospective non-randomized clinical study of 15 patients to determine if the safety and effectiveness of the Extended Longevity Protocol's impact on the nine determinant factors of aging can decelerate aging.

There is evidence that the Extended Longevity Protocol decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of the Extended Longevity Protocol as an effective treatment option to improve clinical care of healthy individual's biological age thus prolonging longevity.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• 8 Men and 7 Women

• Must between 55-75 years old

• Patient must be able to comply with treatment plan and laboratory tests

• Patients must have adequate immune system function, with no known immunodeficiency disease

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) disease

• 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 required blood sample for testing

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Extracts found in the Extended Longevity supplements
Ingredients found in these serums are all naturally occurring, and extracted from a variety of plant species.

Locations

Country	Name	City	State
United States	Quantum Functional Medicine	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
TruDiagnostic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetic Age	Serum epigenetic aging test	Testing will compare the change in results from baseline to 3 months
Primary	Epigenetic Age	serum epigenetic aging test	Testing will compare the change in results after completion of intervention with baseline