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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234203
• Other study ID #: BBH-PRS-001
• Status: Completed
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: October 7, 2022

Study information

• Verified date: December 2022
• Source: Big Bold Health, PBC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Immune System Diseases
• Immunity Disorders
• Inflammation

Intervention

Dietary Supplement:
• HTB Rejuvenate
90 days of BID dosing of 2 capsules of HTB Rejuvenate

Locations

Country	Name	City	State
United States	Big Bold Health PBC	Bainbridge Island	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Big Bold Health, PBC	TruDiagnostic

Country where clinical trial is conducted

United States, 

References & Publications (17)

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Del Bo' C, Bernardi S, Marino M, Porrini M, Tucci M, Guglielmetti S, Cherubini A, Carrieri B, Kirkup B, Kroon P, Zamora-Ros R, Liberona NH, Andres-Lacueva C, Riso P. Systematic Review on Polyphenol Intake and Health Outcomes: Is there Sufficient Evidence to Define a Health-Promoting Polyphenol-Rich Dietary Pattern? Nutrients. 2019 Jun 16;11(6):1355. doi: 10.3390/nu11061355. — View Citation

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Nishimura, M., Ohkawara, T., Sato, Y., Satoh, H., Suzuki, T., Ishiguro, K., ... & Nishihira, J. (2016). Effectiveness of rutin-rich Tartary buckwheat (Fagopyrum tataricum Gaertn.)'Manten-Kirari'in body weight reduction related to its antioxidant properties: A randomised, double-blind, placebo-controlled study. Journal of Functional Foods, 26, 460-469. https://doi.org/10.1016/j.jff.2016.08.004

Santos JC, Ribeiro ML, Gambero A. The Impact of Polyphenols-Based Diet on the Inflammatory Profile in COVID-19 Elderly and Obese Patients. Front Physiol. 2021 Jan 12;11:612268. doi: 10.3389/fphys.2020.612268. eCollection 2020. — View Citation

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Stojkovic L, Zec M, Zivkovic M, Bundalo M, Boškovic M, Glibetic M, Stankovic A. Polyphenol-Rich Aronia melanocarpa Juice Consumption Affects LINE-1 DNA Methylation in Peripheral Blood Leukocytes in Dyslipidemic Women. Front Nutr. 2021 Jun 17;8:689055. doi: 10.3389/fnut.2021.689055. eCollection 2021. — View Citation

Wieslander G, Fabjan N, Vogrincic M, Kreft I, Janson C, Spetz-Nystrom U, Vombergar B, Tagesson C, Leanderson P, Norback D. Eating buckwheat cookies is associated with the reduction in serum levels of myeloperoxidase and cholesterol: a double blind crossover study in day-care centre staffs. Tohoku J Exp Med. 2011 Oct;225(2):123-30. doi: 10.1620/tjem.225.123. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Leukocyte profiling	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	Change from baseline to 90 days