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

Primary Purpose

Immunity Disorders, Aging, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HTB Rejuvenate
Sponsored by
Big Bold Health, PBC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Immunity Disorders focused on measuring Inflammaging, Immunosenescence, Polyphenol, Phytochemical, Phytonutrient, Tartary buckwheat, Fagopyrum tataricum

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Big Bold Health PBC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HTB Rejuvenate

Arm Description

4 capsules of study interventional supplement delivered as 2 capsules two times a day for 90 days.

Outcomes

Primary Outcome Measures

Epigenetic immune age
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

Secondary Outcome Measures

Leukocyte profiling
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

Full Information

First Posted
February 1, 2022
Last Updated
December 5, 2022
Sponsor
Big Bold Health, PBC
Collaborators
TruDiagnostic
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1. Study Identification

Unique Protocol Identification Number
NCT05234203
Brief Title
The Impact of a Polyphenol-Rich Supplement on Epigenetic and Cellular Markers of Immune Age
Official Title
The Impact of a Polyphenol-Rich Supplement on Epigenetic and Cellular Markers of Immune Age
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
October 7, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Big Bold Health, PBC
Collaborators
TruDiagnostic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity Disorders, Aging, Inflammation
Keywords
Inflammaging, Immunosenescence, Polyphenol, Phytochemical, Phytonutrient, Tartary buckwheat, Fagopyrum tataricum

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, interventional, single-arm, open-label pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HTB Rejuvenate
Arm Type
Experimental
Arm Description
4 capsules of study interventional supplement delivered as 2 capsules two times a day for 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
HTB Rejuvenate
Intervention Description
90 days of BID dosing of 2 capsules of HTB Rejuvenate
Primary Outcome Measure Information:
Title
Epigenetic immune age
Description
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
Time Frame
Change from baseline to 90 days
Secondary Outcome Measure Information:
Title
Leukocyte profiling
Description
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
Time Frame
Change from baseline to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Bland, Ph.D
Organizational Affiliation
Big Bold Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Austin D Perlmutter, MD
Organizational Affiliation
Big Bold Health
Official's Role
Study Director
Facility Information:
Facility Name
Big Bold Health PBC
City
Bainbridge Island
State/Province
Washington
ZIP/Postal Code
98110-1793
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Impact of a Polyphenol-Rich Supplement on Epigenetic and Cellular Markers of Immune Age

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