Effects of 21-day Purification Program on Healthy Adults

NCT05877365 | Completed

• 1 other identifier: SP-019-2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Purification; Whole Food Vitamins; Detoxification

Outcome Measures

Primary Outcomes (1)

• Porphyrins in Urine

  Using a kit, urinary porphyrins will be measured.

  58 days

Secondary Outcomes (4)

• Changes in GGT

  58 days

• Changes in GST

  58 days

• Questionnaire

  58 days

• Changes in Weight

  58 days

Study Arms (2)

Diet Only

NO INTERVENTION

Following the same diet as the Purification group

Purification

EXPERIMENTAL

Following a diet along with whole food based supplementation

Dietary Supplement: Standard Process 21-Day Purification Program

Interventions

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.

Purification

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee.
• Willingness to comply with study protocol for 58 days
• Willingness to come and provide samples on all 4 study visits
• No allergy to any study products (a complete list of what supplements will assist is provided below))
• Subject is \>18 years of age
• Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit, and is not actively planning a pregnancy
• Subject has at least two weeks wash out period between completion of a previous research study that required ingestion of any study food or drug and their start in the current study
• Willingness to stay compliant for 22 days and not participate in another research study

You may not qualify if:

• Prohibited Medications, Supplements or Herbal Products
• Subjects who are experiencing any adverse events due to any nutraceutical, OTC, or pharmaceutical or investigational products
• Celiac and other gastrointestinal health concerns
• Subjects may not receive any other investigational products not part of normal clinical care
• Lipid lowering drugs in the preceding 4 weeks and for duration of study \[examples- statins, cholesterol absorption inhibitors like Ezetimibe (Zetia), PCSK9 inhibitors like Alirocumab (Praluent), Evolocumab (Repatha) etc.\]
• The use of anticoagulant medications in the preceding 4 weeks and for duration of study \[Examples: apixaban (Eliquis), betrixaban (Bevyxxa), edoxaban (Savaysa), and rivaroxaban (Xarelto) etc.\]
• 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)

Sponsors & Collaborators

• Standard Process Inc.: lead
• Keiser University College of Chiropractic Medicine: collaborator

Study Sites (1)

Keiser University Spine Care Clinic

West Palm Beach, Florida, 33411, United States

Location

Related Publications (14)

• 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.

  PMID: 22315626 BACKGROUND

• Liska DJ. The detoxification enzyme systems. Altern Med Rev. 1998 Jun;3(3):187-98.

  PMID: 9630736 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.

  PMID: 16781626 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.

  PMID: 26167297 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.

  PMID: 27418630 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.

  PMID: 2547649 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.

  PMID: 12809732 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.

  PMID: 15346644 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.

  PMID: 21179168 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.

  PMID: 29164133 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.

  PMID: 27924283 BACKGROUND

• Brewster MA. Biomarkers of xenobiotic exposures. Ann Clin Lab Sci. 1988 Jul-Aug;18(4):306-17.

  PMID: 3044268 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.

  PMID: 33488302 BACKGROUND

• 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.

  PMID: 40860479 DERIVED

Study Officials

• Chinmayee Panda, PhD

  Standard Process Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: diet only vs whole food supplement based intervention

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: May 26, 2023
• Study Start: June 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

US (1)