Effects of 21-day Purification Program on Healthy Adults

November 12, 2024 updated by: Standard Process Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33411
        • Keiser University Spine care clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Diet Only
Following the same diet as the Purification group
Experimental: Purification
Following a diet along with whole food based supplementation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Porphyrins in Urine
Time Frame: 58 days
Using a kit, urinary porphyrins will be measured.
58 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in GGT
Time Frame: 58 days
A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels
58 days
Changes in GST
Time Frame: 58 days
A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels
58 days
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.
58 days
Changes in Weight
Time Frame: 58 days
Participants will be weighed at each visit to help evaluate health
58 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Standard Process Inc.

Collaborators

Keiser University College of Chiropractic Medicine

Investigators

  • Principal Investigator: Chinmayee Panda, PhD, Standard Process Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SP-019-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Standard Process 21-Day Purification Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe