Guided Metabolic Detox Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Detoxification Response

Intervention / Treatment
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* Dietary Supplement: SP Detox Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Education and healthy diet<br>The healthy diet education session included a PowerPoint presentation on healthy dietary guidelines and sample recipes of healthy meals. | |
| Experimental: Detox<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 
| Oxidative Stress | Colorimetric method to study redox status of peripheral blood mononuclear cells (PBMCs) in Relative fluorescence units (RFU) | 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. | 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 | 28 days | 
| Urinary Detox marker | Excreted Porphyrins concentration in urine (nmol/mg) | 28 days | 
| Hepatic detox marker -1 | Excreted D-glucaric acid concentration in urine ((nM/mg) | 28 days | 
| Hepatic detox marker -2 | Excreted Mercapturic acid concentration in urine ((μM/mM) | 28 days | 
| Total Glutathione | Serum concentration of Glutathione (uM) was measured as part of a fluorometric assay. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Detoxification, Whole Food Vitamins, Glutathione, liver, antioxidants, SOD, GST