Aging, Immunity Disorders, Inflammation
Conditions
Keywords
Inflammaging, Immunosenescence, Polyphenol, Phytochemical, Phytonutrient, Tartary buckwheat, Fagopyrum tataricum
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.
Interventions
DIETARY_SUPPLEMENTHTB Rejuvenate
90 days of BID dosing of 2 capsules of HTB Rejuvenate
Sponsors
TruDiagnostic
Big Bold Health, PBC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, interventional, single-arm, open-label pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed