Effects of 21-day Purification Program on Healthy Adults

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05877365

Run by

Standard Process Inc.

People needed

32

Starts

2023-06-15

Expected to finish

2024-01-15

Last updated by the study team

2024-11-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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
• 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

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)
• 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

Where it is running

• Keiser University Spine Care Clinic — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

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