De-Rusha Clinic, Northwestern Health Sciences University
Bloomington, Minnesota, 55431, United States
NCT Number: NCT06061289
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Bloomington, Minnesota, 55431, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: 28 days
Colorimetric method to study redox status of peripheral blood mononuclear cells (PBMCs) in Relative fluorescence units (RFU)
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.
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
Time frame: 28 days
Excreted Porphyrins concentration in urine (nmol/mg)
Time frame: 28 days
Excreted D-glucaric acid concentration in urine ((nM/mg)
Time frame: 28 days
Excreted Mercapturic acid concentration in urine ((μM/mM)
Time frame: 28 days
Serum concentration of Glutathione (uM) was measured as part of a fluorometric assay.
Standard Process Inc.
Industry
Effects of Standard Process's SP Detox Balance Dietary Supplements on Metabolic Detoxification
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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.