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Immunity DisordersNCT05234203

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

A study testing HTB Rejuvenate in people with Immunity Disorders and Aging, run by Big Bold Health, PBC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Immunity Disorders, Aging, Inflammation
What is being tested?
HTB Rejuvenate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
25 Mar 2022to 7 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Big Bold Health PBC

    Bainbridge Island, Washington, 98110-1793

Other trials in United States

About this study

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.

Read the 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.

Being tested
HTB Rejuvenate
Keywords
Inflammaging, Immunosenescence, Polyphenol, Phytochemical, Phytonutrient, Tartary buckwheat, Fagopyrum tataricum
Medical subject headings
Immune System Diseases, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTB RejuvenateDietary supplement

    90 days of BID dosing of 2 capsules of HTB Rejuvenate

Study groups in NCT05234203
Study groupRoleWhat they receive
HTB RejuvenateExperimental4 capsules of study interventional supplement delivered as 2 capsules two times a day for 90 days.
Receives: Dietary Supplement: HTB Rejuvenate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change from baseline to 90 days

Secondary outcomes (1)

  1. 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

    Measured: Change from baseline to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start25 Mar 2022
  3. Primary completion7 Oct 2022
  4. Study completion7 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, interventional, single-arm, open-label pilot study
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234203
Sponsor's protocol ID
BBH-PRS-001
Status last verified
Dec 2022
First submitted
1 Feb 2022
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kontis V, Bennett JE, Mathers CD, Li G, Foreman K, Ezzati M. Future life expectancy in 35 industrialised countries: projections with a Bayesian model ensemble. Lancet. 2017 Apr 1;389(10076):1323-1335. doi: 10.1016/S0140-6736(16)32381-9. Epub 2017 Feb 22.

    PubMed 28236464

  • Gensous N, Garagnani P, Santoro A, Giuliani C, Ostan R, Fabbri C, Milazzo M, Gentilini D, di Blasio AM, Pietruszka B, Madej D, Bialecka-Debek A, Brzozowska A, Franceschi C, Bacalini MG. One-year Mediterranean diet promotes epigenetic rejuvenation with country- and sex-specific effects: a pilot study from the NU-AGE project. Geroscience. 2020 Apr;42(2):687-701. doi: 10.1007/s11357-019-00149-0. Epub 2020 Jan 24.

    PubMed 31981007

  • Fitzgerald KN, Hodges R, Hanes D, Stack E, Cheishvili D, Szyf M, Henkel J, Twedt MW, Giannopoulou D, Herdell J, Logan S, Bradley R. Potential reversal of epigenetic age using a diet and lifestyle intervention: a pilot randomized clinical trial. Aging (Albany NY). 2021 Apr 12;13(7):9419-9432. doi: 10.18632/aging.202913. Epub 2021 Apr 12.

    PubMed 33844651

  • Stojkovic L, Zec M, Zivkovic M, Bundalo M, Boskovic 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.

    PubMed 34222308

  • Sharma, R., & Padwad, Y. (2020). Perspectives of the potential implications of polyphenols in influencing the interrelationship between oxi-inflammatory stress, cellular senescence and immunosenescence during aging. Trends in Food Science & Technology, 98, 41-52. https://doi.org/10.1016/j.tifs.2020.02.004

  • 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.

    PubMed 33584335

  • Bahramsoltani R, Ebrahimi F, Farzaei MH, Baratpourmoghaddam A, Ahmadi P, Rostamiasrabadi P, Rasouli Amirabadi AH, Rahimi R. Dietary polyphenols for atherosclerosis: A comprehensive review and future perspectives. Crit Rev Food Sci Nutr. 2019;59(1):114-132. doi: 10.1080/10408398.2017.1360244. Epub 2017 Sep 25.

    PubMed 28812379

  • Amiot MJ, Riva C, Vinet A. Effects of dietary polyphenols on metabolic syndrome features in humans: a systematic review. Obes Rev. 2016 Jul;17(7):573-86. doi: 10.1111/obr.12409. Epub 2016 Apr 15.

    PubMed 27079631

  • Sharma R, Padwad Y. Plant-polyphenols based second-generation synbiotics: Emerging concepts, challenges, and opportunities. Nutrition. 2020 Sep;77:110785. doi: 10.1016/j.nut.2020.110785. Epub 2020 Mar 2.

    PubMed 32283341

  • da Silveira Vasconcelos, M., de Oliveira, L. M. N., Mota, E. F., de Siqueira Oliveira, L., Gomes-Rochette, N. F., Nunes-Pinheiro, D. C. S., ... & de Melo, D. F. (2020). Consumption of rich/enrich phytonutrients food and their relationship with health status of population. In Phytonutrients in Food (pp. 67-101). Woodhead Publishing. https://doi.org/10.1016/B978-0-12-815354-3.00006-X

  • Liu RH. Health benefits of fruit and vegetables are from additive and synergistic combinations of phytochemicals. Am J Clin Nutr. 2003 Sep;78(3 Suppl):517S-520S. doi: 10.1093/ajcn/78.3.517S.

    PubMed 12936943

  • Huda MN, Lu S, Jahan T, Ding M, Jha R, Zhang K, Zhang W, Georgiev MI, Park SU, Zhou M. Treasure from garden: Bioactive compounds of buckwheat. Food Chem. 2021 Jan 15;335:127653. doi: 10.1016/j.foodchem.2020.127653. Epub 2020 Jul 24.

    PubMed 32739818

  • Dziedzic K, Gorecka D, Szwengiel A, Sulewska H, Kreft I, Gujska E, Walkowiak J. The Content of Dietary Fibre and Polyphenols in Morphological Parts of Buckwheat (Fagopyrum tataricum). Plant Foods Hum Nutr. 2018 Mar;73(1):82-88. doi: 10.1007/s11130-018-0659-0.

    PubMed 29435700

  • Caputo M, Bona E, Leone I, Sama MT, Nuzzo A, Ferrero A, Aimaretti G, Marzullo P, Prodam F. Inositols and metabolic disorders: From farm to bedside. J Tradit Complement Med. 2020 Mar 24;10(3):252-259. doi: 10.1016/j.jtcme.2020.03.005. eCollection 2020 May.

    PubMed 32670820

  • 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.

    PubMed 21931228

Questions about this trial

What is this clinical trial studying?

A study testing HTB Rejuvenate in people with Immunity Disorders and Aging, run by Big Bold Health, PBC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epigenetic immune age (time frame: Change from baseline to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234203, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.

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