Safety & Efficacy of Extended Longevity Protocol

Sponsor

TruDiagnostic (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05296993

Collaborator

(none)

Enrollment

Location

Arm

30.2

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aging	Dietary Supplement: Extracts found in the Extended Longevity supplements	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extracts The ingredients found in these serums are all naturally occurring ingredients extracted from a variety of plant species: Pinetonal, Thyvolve, Telogenic, Sentophagy, Inflasolve, Stemegenis, and CMEnhance	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.

Arm

Intervention/Treatment

Experimental: Extracts

The ingredients found in these serums are all naturally occurring ingredients extracted from a variety of plant species: Pinetonal, Thyvolve, Telogenic, Sentophagy, Inflasolve, Stemegenis, and CMEnhance

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.

Outcome Measures

Primary Outcome Measures

Epigenetic Age [Testing will compare the change in results from baseline to 3 months]
Serum epigenetic aging test
Epigenetic Age [Testing will compare the change in results after completion of intervention with baseline]
serum epigenetic aging test

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quantum Functional Medicine	Carlsbad	California	United States	92008

Sponsors and Collaborators

TruDiagnostic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TruDiagnostic

ClinicalTrials.gov Identifier:

NCT05296993

Other Study ID Numbers:

TD-EL-001

First Posted:

Mar 25, 2022

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 11, 2022