Effects of 21-day Purification Program on Healthy Adults

Sponsor

Standard Process Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05877365

Collaborator

Keiser University College of Chiropractic Medicine (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Standard Process 21-Day Purification Program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

diet only vs whole food supplement based interventiondiet only vs whole food supplement based intervention

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Porphyrins in Urine [58 days]
Using a kit, urinary porphyrins will be measured.

Secondary Outcome Measures

Changes in GGT [58 days]
A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels
Changes in GST [58 days]
A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels
Questionnaire [58 days]
PROMIS Global 10 Health Questionnaire will be used for the participant to evaluate their own health on a scale from 1-5.
Changes in Weight [58 days]
Participants will be weighed at each visit to help evaluate health

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Standard Process Inc.
Keiser University College of Chiropractic Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

How to Reduce Your Exposure to chemicals at home, work and play

Publications

Responsible Party:

Standard Process Inc.

ClinicalTrials.gov Identifier:

NCT05877365

Other Study ID Numbers:

SP-019-2

First Posted:

May 26, 2023

Last Update Posted:

May 26, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Standard Process Inc.

Purification

Whole Food Vitamins

Detoxification

Study Results

No Results Posted as of May 26, 2023