Clinical trial NCT05234203: 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
Overall status: COMPLETED
Phase: NA
Conditions: Immunity Disorders
Aging
Inflammation
Keywords: Inflammaging
Immunosenescence
Polyphenol
Phytochemical
Phytonutrient
Tartary buckwheat
Fagopyrum tataricum
Lead sponsor: Big Bold Health, PBC
Sponsor class: INDUSTRY
Collaborators: name: TruDiagnostic
First posted: 2022-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, interventional, single-arm, open-label pilot study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Epigenetic immune age
timeFrame: Change from baseline to 90 days
Secondary outcomes:
measure: Leukocyte profiling
timeFrame: Change from baseline to 90 days
Other outcomes:
Locations:
city: Bainbridge Island
country: United States
facility: Big Bold Health PBC
state: Washington
Study officials:
affiliation: Big Bold Health
name: Jeffrey S Bland, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Big Bold Health
name: Austin D Perlmutter, MD
role: STUDY_DIRECTOR
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