Effects of 21-day Purification Program on Healthy Adults

Healthy Clinical Trial

Official title:

Effects of Standard Process's 21-day Guided Purification Program on Metabolic Health in College Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05877365
• Other study ID #: SP-019-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: May 2023
• Source: Standard Process Inc.
• Contact: Chinmayee Panda, PhD
• Phone: 2624956571
• Email: cpanda[@]standardprocess.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 15, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

• If on a chronic medication (that does not result in exclusion), subject has been on stable dose for at least two months prior to screening visit

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Standard Process 21-Day Purification Program
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Standard Process Inc.	Keiser University College of Chiropractic Medicine

References & Publications (13)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Porphyrins in Urine	Using a kit, urinary porphyrins will be measured.	58 days
Secondary	Changes in GGT	A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels	58 days
Secondary	Changes in GST	A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels	58 days
Secondary	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
Secondary	Changes in Weight	Participants will be weighed at each visit to help evaluate health	58 days

External Links

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