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

Big Bold Health

Status

Completed

Conditions

Aging

Inflammation

Immunity Disorders

Treatments

Dietary Supplement: HTB Rejuvenate

Study type

Interventional

Funder types

Industry

Identifiers

NCT05234203

BBH-PRS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts 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