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

Not Applicable

Completed

• Conditions: Aging; Immunity Disorders; Inflammation
• Interventions: Dietary Supplement: HTB Rejuvenate

• Registration Number: NCT05234203
• Lead Sponsor: Big Bold Health, PBC

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.

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Study Start: 2022-03-25
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HTB Rejuvenate	HTB Rejuvenate	4 capsules of study interventional supplement delivered as 2 capsules two times a day for 90 days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Big Bold Health PBC; 🇺🇸 Bainbridge Island, Washington, United States