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Completed

NCT Number: NCT05877365

Effects of 21-day Purification Program on Healthy Adults

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keiser University Spine Care Clinic

West Palm Beach, Florida, 33411, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Porphyrins in Urine

    Time frame: 58 days

    Using a kit, urinary porphyrins will be measured.

Secondary outcomes

  1. Changes in GGT

    Time frame: 58 days

    A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels

  2. Changes in GST

    Time frame: 58 days

    A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels

  3. Questionnaire

    Time frame: 58 days

    PROMIS Global 10 Health Questionnaire will be used for the participant to evaluate their own health on a scale from 1-5.

  4. Changes in Weight

    Time frame: 58 days

    Participants will be weighed at each visit to help evaluate health

Sponsors and collaborators

Lead sponsor

Standard Process Inc.

Industry

Collaborators

  • Keiser University College of Chiropractic Medicine

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 26, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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