The Impact of a Polyphenol-Rich Supplement on Epigenetic and Cellular Markers of Immune Age

December 5, 2022 updated by: Big Bold Health, PBC
This is a prospective, interventional, single-arm, open-label pilot study of 50 patients to evaluate the effect of a polyphenol-rich nutritional supplement on epigenetic and cellular markers of immune age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to understand the impact of a polyphenol-rich supplement on measurements of epigenetic immune age and immune cell patterns germane to immune age over a 90-day period. The primary objective of this trial is to assess the effects of the supplement, HTB Rejuvenate™, on immune age markers. The secondary objective of this trial is to assess the effects of the supplement, HTB Rejuvenate, on leukocyte immune profiles including T cell subsets and granulocytes.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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
    • Washington
      • Bainbridge Island, Washington, United States, 98110-1793
        • Big Bold Health PBC

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women of any ethnicity.
  • Age Range - 18 - 85 (inclusive)
  • Participant must be able to comply with treatment plan and laboratory tests including ability and willingness to perform home venous blood draw using Tasso device.
  • Participant must be able to read, write and speak English fluently
  • Participant must have an established primary care provider
  • Participant must be willing and able to consume 4 capsules per day throughout the duration of study period

Exclusion Criteria:

  • History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
  • Known immune system issues or immunodeficiency disease
  • 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
  • Participants infected with hepatitis C or HIV
  • Body Mass Index (BMI) greater than or equal to 40 kilograms per meter squared
  • Presence of active infection in previous 4 weeks
  • Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the Clinical Investigator would render a participant unsuitable to participate in the study
  • Unable or unwilling to provide required blood sample for testing
  • Current or previous use of known prescription immunomodulating products (e.g. glucocorticoids, tumor necrosis factor (TNF)-alpha inhibitors) in the month prior to the start of the trial.
  • Taking a concentrated polyphenol-focused supplement in the month prior to the start of the trial (e.g., quercetin, Epigallocatechin gallate (EGCG), resveratrol, curcumin, berberine, soy isoflavones, rutin, luteolin fisetin) or products that contain Tartary buckwheat
  • A known history of blood dyscrasias including coagulopathy
  • Current use of prescription anticoagulant medications
  • Current pregnancy, planned attempts to conceive during study period or sexually active females not using contraception, as well as lactating/nursing females
  • Current job that requires night-shift work
  • Known allergy to polyphenolics
  • Known allergy to buckwheat or Tartary buckwheat
  • Investors or immediate family of investors in Big Bold Health
  • Any person deemed by Clinical Investigator as low likelihood of complying with study protocol (e.g. evidence of history of non-compliance, history of poor follow-up, multiple or complex scheduling conflicts).
  • Planned surgical procedure during study period

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HTB Rejuvenate
4 capsules of study interventional supplement delivered as 2 capsules two times a day for 90 days.
Dietary supplement: HTB Rejuvenate
90 days of BID dosing of 2 capsules of HTB Rejuvenate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetic immune age
Time Frame: Change from baseline to 90 days
Measurement of changes in methylation patterns on DNA related to immune age using the TruAge Biological Age test, which tests for methylation at 850,000 separate locations on DNA
Change from baseline to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukocyte profiling
Time Frame: Change from baseline to 90 days
Relative numbers of T cell subsets and granulocytes obtained using deconvolution analysis from epigenetic data obtained from the TruAge Biological Age test, which tests for methylation at 850,000 separate locations on DNA
Change from baseline to 90 days

Collaborators and Investigators

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

Sponsor

Big Bold Health, PBC

Collaborators

TruDiagnostic

Investigators

  • Principal Investigator: Jeffrey S Bland, Ph.D, Big Bold Health
  • Study Director: Austin D Perlmutter, MD, Big Bold Health

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)

March 25, 2022

Primary Completion (Actual)

October 7, 2022

Study Completion (Actual)

October 7, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH-PRS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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