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

Sponsor

Big Bold Health, PBC (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05234203

Collaborator

TruDiagnostic (Industry)

Enrollment

Location

Arm

6.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immunity Disorders Aging Inflammation	Dietary Supplement: HTB Rejuvenate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, interventional, single-arm, open-label pilot studyProspective, interventional, single-arm, open-label pilot study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Epigenetic immune age [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

Secondary Outcome Measures

Leukocyte profiling [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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