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

NCT05234203 | Completed

• 1 other identifier: BBH-PRS-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunity Disorders; Aging; Inflammation

Keywords

Inflammaging; Immunosenescence; Polyphenol; Phytochemical; Phytonutrient; Tartary buckwheat; Fagopyrum tataricum

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline to 90 days

Secondary Outcomes (1)

• Leukocyte profiling

  Change from baseline to 90 days

Study Arms (1)

HTB Rejuvenate

EXPERIMENTAL

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

Dietary Supplement: HTB Rejuvenate

Interventions

HTB Rejuvenate DIETARY_SUPPLEMENT

90 days of BID dosing of 2 capsules of HTB Rejuvenate

HTB Rejuvenate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Big Bold Health, PBC: lead
• TruDiagnostic: collaborator

Study Sites (1)

Big Bold Health PBC

Bainbridge Island, Washington, 98110-1793, United States

Location

Related Publications (18)

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  BACKGROUND

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• Perlmutter A, Bland JS, Chandra A, Malani SS, Smith R, Mendez TL, Dwaraka VB. The impact of a polyphenol-rich supplement on epigenetic and cellular markers of immune age: a pilot clinical study. Front Nutr. 2024 Nov 18;11:1474597. doi: 10.3389/fnut.2024.1474597. eCollection 2024.

  PMID: 39628466 DERIVED

MeSH Terms

Conditions

Immune System Diseases; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey S Bland, Ph.D

  Big Bold Health

  PRINCIPAL INVESTIGATOR

• Austin D Perlmutter, MD

  Big Bold Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, single-arm, open-label pilot study

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: March 25, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

US (1)