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| Name | Class |
|---|---|
| Keiser University College of Chiropractic Medicine | OTHER |
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This is a study to assess the impact of Standard Process's 21-Day Purification Program on metabolic health. Participants will be given the opportunity to consume the complex combination of vitamins, minerals, and antioxidants that comprise the 21-Day Guided Purification Program by Standard Process.
Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load we are exposed to daily may take a toll on our physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the human body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Only | No Intervention | Following the same diet as the Purification group | |
| Purification | Experimental | Following a diet along with whole food based supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Process 21-Day Purification Program | Dietary Supplement | Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load humans are exposed to daily may take a toll on physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality. |
| Measure | Description | Time Frame |
|---|---|---|
| Porphyrins in Urine | Using a kit, urinary porphyrins will be measured. | 58 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in GGT | A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels | 58 days |
| Changes in GST | A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels |
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Inclusion Criteria:
Exclusion Criteria:
Prohibited Medications, Supplements or Herbal Products
Pregnant and nursing women are excluded from participation and women of childbearing age expecting to be pregnant soon will be excluded from the study
Subjects with untreated endocrine, neurological, or infectious disease
Subjects with the diagnosis of HIV disease or AIDS
Significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment)
Rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, polymyositis, scleroderma, polymyalgia rheumatic, temporal arteritis or Reiter's Syndrome
Psoriasis, Deep vein thrombosis or pulmonary embolus (blood clot to lungs)
History of cancer
Serious medical illness like high TG levels >150 mg/DL for example
Substance Use - Use of ethanol within 24 hours of the evaluation visits (all 4 visits)
Any other sound medical, psychiatric and/or social reason as determined by the PI
Co-enrollment in other studies is restricted. Study staff should be notified of co-enrollment as it may require the approval of the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Chinmayee Panda, PhD | Standard Process Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keiser University Spine Care Clinic | West Palm Beach | Florida | 33411 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22315626 | Background | Sears ME, Genuis SJ. Environmental determinants of chronic disease and medical approaches: recognition, avoidance, supportive therapy, and detoxification. J Environ Public Health. 2012;2012:356798. doi: 10.1155/2012/356798. Epub 2012 Jan 19. | |
| 9630736 | Background | Liska DJ. The detoxification enzyme systems. Altern Med Rev. 1998 Jun;3(3):187-98. |
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diet only vs whole food supplement based intervention
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| 58 days |
| Questionnaire | PROMIS Global 10 Health Questionnaire will be used for the participant to evaluate their own health on a scale from 1-5. | 58 days |
| Changes in Weight | Participants will be weighed at each visit to help evaluate health | 58 days |
| 16781626 | Background | Liska D, Lyon M, Jones DS. Detoxification and biotransformational imbalances. Explore (NY). 2006 Mar;2(2):122-40. doi: 10.1016/j.explore.2005.12.009. No abstract available. |
| 26167297 | Background | Hodges RE, Minich DM. Modulation of Metabolic Detoxification Pathways Using Foods and Food-Derived Components: A Scientific Review with Clinical Application. J Nutr Metab. 2015;2015:760689. doi: 10.1155/2015/760689. Epub 2015 Jun 16. |
| 27418630 | Background | Griendling KK, Touyz RM, Zweier JL, Dikalov S, Chilian W, Chen YR, Harrison DG, Bhatnagar A; American Heart Association Council on Basic Cardiovascular Sciences. Measurement of Reactive Oxygen Species, Reactive Nitrogen Species, and Redox-Dependent Signaling in the Cardiovascular System: A Scientific Statement From the American Heart Association. Circ Res. 2016 Aug 19;119(5):e39-75. doi: 10.1161/RES.0000000000000110. Epub 2016 Jul 14. |
| 2547649 | Background | Zweier JL, Duke SS, Kuppusamy P, Sylvester JT, Gabrielson EW. Electron paramagnetic resonance evidence that cellular oxygen toxicity is caused by the generation of superoxide and hydroxyl free radicals. FEBS Lett. 1989 Jul 31;252(1-2):12-6. doi: 10.1016/0014-5793(89)80881-6. |
| 12809732 | Background | Pastore A, Federici G, Bertini E, Piemonte F. Analysis of glutathione: implication in redox and detoxification. Clin Chim Acta. 2003 Jul 1;333(1):19-39. doi: 10.1016/s0009-8981(03)00200-6. |
| 15346644 | Background | Lee DH, Blomhoff R, Jacobs DR Jr. Is serum gamma glutamyltransferase a marker of oxidative stress? Free Radic Res. 2004 Jun;38(6):535-9. doi: 10.1080/10715760410001694026. |
| 21179168 | Background | Chen CA, Wang TY, Varadharaj S, Reyes LA, Hemann C, Talukder MA, Chen YR, Druhan LJ, Zweier JL. S-glutathionylation uncouples eNOS and regulates its cellular and vascular function. Nature. 2010 Dec 23;468(7327):1115-8. doi: 10.1038/nature09599. |
| 29164133 | Background | Varadharaj S, Kelly OJ, Khayat RN, Kumar PS, Ahmed N, Zweier JL. Role of Dietary Antioxidants in the Preservation of Vascular Function and the Modulation of Health and Disease. Front Cardiovasc Med. 2017 Nov 1;4:64. doi: 10.3389/fcvm.2017.00064. eCollection 2017. |
| 27924283 | Background | Kim JA, Kim JY, Kang SW. Effects of the Dietary Detoxification Program on Serum gamma-glutamyltransferase, Anthropometric Data and Metabolic Biomarkers in Adults. J Lifestyle Med. 2016 Sep;6(2):49-57. doi: 10.15280/jlm.2016.6.2.49. Epub 2016 Sep 30. |
| 3044268 | Background | Brewster MA. Biomarkers of xenobiotic exposures. Ann Clin Lab Sci. 1988 Jul-Aug;18(4):306-17. |
| 33488302 | Background | Bonakdar RA, Sweeney M, Dalhoumi S, Adair V, Garvey C, Hodge T, Herrala L, Barbee A, Case C, Kearney J, Smith K, Hwang J. Detoxification Enhanced Lifestyle Intervention Targeting Endotoxemia (DELITE) in the Setting of Obesity and Pain: Results of a Pilot Group Intervention. Integr Med (Encinitas). 2020 Oct;19(5):16-28. |
| 40860479 | Derived | Panda C, Kruse R, Williams K, Nance B, Gudavalli M, Pourafshar S, Metzger B, Komarnytsky S. Metabolic reset purification program improves antioxidant balance and gut microbiome in individuals transitioning to a healthier diet. Front Nutr. 2025 Aug 11;12:1621709. doi: 10.3389/fnut.2025.1621709. eCollection 2025. |