An interventional study of SP Detox Program in Detoxification Response, sponsored by Standard Process Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Standard Process Inc. · Not applicable, Interventional, and Supportive care
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.
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.
Standard Process Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prohibited Medications, Supplements or Herbal Products
The healthy diet education session included a PowerPoint presentation on healthy dietary guidelines and sample recipes of healthy meals.
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
Promis Global 10 (Self- reported Wellness) Questionnaire
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.
Time frame: 28 days
Total Serum Antioxidants
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.
Time frame: 28 days
Oxidative Stress
Colorimetric method to study redox status of peripheral blood mononuclear cells (PBMCs) in Relative fluorescence units (RFU)
Time frame: 28 days
Detoxification Enzyme Activity - SOD
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.
Time frame: 28 days
Detoxification Enzyme Activity - GST
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
Time frame: 28 days
Urinary Detox marker
Excreted Porphyrins concentration in urine (nmol/mg)
Time frame: 28 days
Hepatic detox marker -1
Excreted D-glucaric acid concentration in urine ((nM/mg)
Time frame: 28 days
Hepatic detox marker -2
Excreted Mercapturic acid concentration in urine ((μM/mM)
Time frame: 28 days
Total Glutathione
Serum concentration of Glutathione (uM) was measured as part of a fluorometric assay.
Time frame: 28 days
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Standard Process Inc.