Guided Metabolic Detox Program

September 27, 2023 updated by: Standard Process Inc.

Effects of Standard Process's SP Detox Balance Dietary Supplements on Metabolic Detoxification

Adequate antioxidant supply is essential for maintaining metabolic homeostasis and reducing oxidative stress during detoxification. The emerging evidence suggests that certain classes of phytonutrients can help support the detoxification process by stimulating the liver to produce detoxification enzymes or acting as antioxidants that neutralize the harmful effects of free radicals. This study was designed to examine the effects of a guided 28-day metabolic detoxification program in healthy adults. The participants were randomly assigned to consume a whole food, multi-ingredient supplement (education and intervention) or control (education and healthy meal) daily for the duration of the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the focus is on a cohort of healthy adults enrolled in a guided detoxification program that included a healthy diet education session with or without 28-day nutritional supplementation with a whole food, proprietary multicomponent blend. The primary objective was to determine the improvement in quality of life by a validated self-reported wellness questionnaire known as Promis Global 10. The secondary outcomes were to quantify the functional markers of metabolic detoxification in blood and urine compared to the study baseline to understand the efficacy of the study formulation as part of 28-day nutritional supplementation with a whole food, proprietary multicomponent blend.

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
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • De-Rusha Clinic, Northwestern Health Sciences University

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:

  • Willingness to comply with study protocol for 30 days
  • No allergy to any study products (check formulation section below)
  • Participant is over 18 years of age or older
  • Participant 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.
  • Participant 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.

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 or the use of anticoagulant medications in the preceding 4 weeks and for duration of study
  • Pregnant and nursing women are excluded from participation and women of childbearing age expecting to be pregnant soon will be excluded from the study
  • TC levels less than 220
  • 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
  • Substance Use - Use of ethanol within 24 hours of the evaluation visits (baseline, 4 weeks)
  • 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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Education and healthy diet
The healthy diet education session included a PowerPoint presentation on healthy dietary guidelines and sample recipes of healthy meals.
Experimental: Detox
The guided component of the detoxification program included an additional PowerPoint presentation with the information about the investigational product, directions, and dosing information for its consumption.
Dietary supplement: SP Detox Program
The production use and disposal of toxic chemicals and synthetic materials have increased the risk of exposure to health-threatening toxins. Causal relationships between toxic chemicals and diseases have been well established. However, many patients endure chronic symptoms that are associated with exposure to toxins before advanced stages of specific diseases are realized. Thus, there is a great demand for noninvasive laboratory tests that can provide timely assessment of chemical exposure and the capability of hepatic detoxification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Promis Global 10 (Self- reported Wellness) Questionnaire
Time Frame: 28 days
The PROMIS Global short form was scored into a Global Physical Health component and Global Mental Health component. The summed raw scores from PROMIS Global were converted into standardized T-score distributions such that a 50 represents the average (mean) for the US general population. A high score always represents more of the concept being measured.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Serum Antioxidants
Time Frame: 28 days
Total Antioxidant Capacity ( μM ) measured as the combined antioxidant activities of all serum constituents, including vitamins, proteins, lipids, glutathione, and uric acid. This assay will be performed using a commercial kit following manufacturer's instruction.
28 days
Oxidative Stress
Time Frame: 28 days
Colorimetric method to study redox status of peripheral blood mononuclear cells (PBMCs) in Relative fluorescence units (RFU)
28 days
Detoxification Enzyme Activity - SOD
Time Frame: 28 days
Assessment of SOD activity (units/mL) using an assay that utilizes a tetrazolium salt for detection of superoxide radicals generated by xanthine oxidase and hypoxanthine using a colorimetric method.
28 days
Detoxification Enzyme Activity - GST
Time Frame: 28 days
Total GST activity (units/mL) measured by quantifying the conjugation of 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione using a glutathione S-transferase assay kit
28 days
Urinary Detox marker
Time Frame: 28 days
Excreted Porphyrins concentration in urine (nmol/mg)
28 days
Hepatic detox marker -1
Time Frame: 28 days
Excreted D-glucaric acid concentration in urine ((nM/mg)
28 days
Hepatic detox marker -2
Time Frame: 28 days
Excreted Mercapturic acid concentration in urine ((μM/mM)
28 days
Total Glutathione
Time Frame: 28 days
Serum concentration of Glutathione (uM) was measured as part of a fluorometric assay.
28 days

Collaborators and Investigators

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

Sponsor

Standard Process Inc.

Collaborators

Northwestern Health Sciences University

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)

March 6, 2022

Primary Completion (Actual)

August 27, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SP-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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