Safety and Effectivness of Quercetin & Dasatinib on Epigenetic Aging

August 2, 2021 updated by: TruDiagnostic

The Safety and Effectivness of Quercetin and Dasatinib on the Epigenetic Aging Rates in Healthy Individuals

Assessing the effects of Quercitin and Dasatinib over a 16 week period on participatns' epigenetic biological aging. The patients are being tested at baseline, halfway point, and after the trial period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective non-randomized clinical study of 20-25 patients to evaluate the effectiveness of Quercetin and Dasatinib supplements on the patient's epigenetic aging rate. The investigators predict that Quercetin and Dasatinib combined will slow cell proliferation and thus decelerate the rate of aging.

There is evidence that Quercetin and Dasatinib slows cell proliferation and decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of Quercetin and Dasatinib as an effective treatment option to improve clinical care of healthy individual's epigenetic aging rate thus prolonging longevity.

Despite considerable effort, successful treatment of reversing one's biological age has been shown to be a difficult therapeutic challenge. There is evidence that Dasatinib+Quercetin(Quercetin and Dasatinib) is a safe and effective treatment option to improve clinical care of healthy individual's biological age. Studies have shown that Dasatinib+Quercetin slows cell proliferation and decelerates aging and the risk of age-related diseases.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32819
        • The Institute for Hormonal Balance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women
  • Ages 40 and older
  • Patient must be able to comply with treatment plan and laboratory tests

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 down regulation
  • 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 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
  • Unable or unwilling to provide 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 Quercetin and Dasatinib.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quercetin and Dasatinib supplements
500mg Quercetin and 50mg Dasatinib oral capsules on Monday, Tuesday, Wednesday (3 days in a row) per month for the duration of 6 months.
Drug: Dasatinib plus Quercetin
Dasatinib plus Quercetin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epigenetic Age Test
Time Frame: Change from baseline to 6 months
Change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examining Methylation changes
Time Frame: Change from baseline to 6 months
Methylation analysis via the Illumina 850k epic array. Methylation will be assessed at 850,000 spots on the DNA, these are located on CpG sites. These are the spots on DNA that have cytosine and guanine right next to each other.
Change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TruDiagnostic

Investigators

  • Principal Investigator: Edwin Lee, MD, The Institute for Hormonal Balance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHB-QD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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