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| Name | Class |
|---|---|
| TruDiagnostic | INDUSTRY |
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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.
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 Rejuvenateâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTB Rejuvenate | Experimental | 4 capsules of study interventional supplement delivered as 2 capsules two times a day for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTB Rejuvenate | Dietary Supplement | 90 days of BID dosing of 2 capsules of HTB Rejuvenate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S Bland, Ph.D | Big Bold Health | Principal Investigator |
| Austin D Perlmutter, MD | Big Bold Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Big Bold Health PBC | Bainbridge Island | Washington | 98110-1793 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28236464 | Background | 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. | |
| 31981007 | Background | 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. |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective, interventional, single-arm, open-label pilot study
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| 27079631 | Background | 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. |
| 32283341 | Background | 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. |
| Background | 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 |
| 12936943 | Background | 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. |
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| Background | 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 |
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| 39628466 | Derived | Perlmutter A, Bland JS, Chandra A, Malani SS, Smith R, Mendez TL, Dwaraka VB. The impact of a polyphenol-rich supplement on epigenetic and cellular markers of immune age: a pilot clinical study. Front Nutr. 2024 Nov 18;11:1474597. doi: 10.3389/fnut.2024.1474597. eCollection 2024. |