Detoxification ResponseNCT06061289
Guided Metabolic Detox Program
A study testing SP Detox Program in people with Detoxification Response, run by Standard Process Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Detoxification Response
- What is being tested?
- SP Detox Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
De-Rusha Clinic, Northwestern Health Sciences University
Bloomington, Minnesota, 55431
About this study
Official title: 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.
Read the 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.
- Conditions
- Detoxification Response
- Being tested
- SP Detox Program
- Keywords
- Detoxification, Whole Food Vitamins, Glutathione, liver, antioxidants, SOD, GST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP Detox ProgramDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Education and healthy diet | No intervention | The healthy diet education session included a PowerPoint presentation on healthy dietary guidelines and sample recipes of healthy meals. |
| Detox | Experimental | 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. Receives: Dietary Supplement: SP Detox Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (8)
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.
Measured: 28 days
Oxidative Stress
Colorimetric method to study redox status of peripheral blood mononuclear cells (PBMCs) in Relative fluorescence units (RFU)
Measured: 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.
Measured: 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
Measured: 28 days
Urinary Detox marker
Excreted Porphyrins concentration in urine (nmol/mg)
Measured: 28 days
Hepatic detox marker -1
Excreted D-glucaric acid concentration in urine ((nM/mg)
Measured: 28 days
Hepatic detox marker -2
Excreted Mercapturic acid concentration in urine ((μM/mM)
Measured: 28 days
Total Glutathione
Serum concentration of Glutathione (uM) was measured as part of a fluorometric assay.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start6 Mar 2022
- Primary completion27 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Detoxification ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern Health Sciences University
- Responsible party
- Sponsor
- Investigators
- Chinmayee Panda, PhD, Principal investigator, Standard Process Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061289
- Sponsor's protocol ID
- SP-016
- Status last verified
- Sep 2023
- First submitted
- 10 Mar 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sears ME, Genuis SJ. Environmental determinants of chronic disease and medical approaches: recognition, avoidance, supportive therapy, and detoxification. J Environ Public Health. 2012;2012:356798. doi: 10.1155/2012/356798. Epub 2012 Jan 19.
PubMed 22315626Bonakdar RA, Sweeney M, Dalhoumi S, Adair V, Garvey C, Hodge T, Herrala L, Barbee A, Case C, Kearney J, Smith K, Hwang J. Detoxification Enhanced Lifestyle Intervention Targeting Endotoxemia (DELITE) in the Setting of Obesity and Pain: Results of a Pilot Group Intervention. Integr Med (Encinitas). 2020 Oct;19(5):16-28.
PubMed 33488302Mostafalou S, Abdollahi M. Pesticides and human chronic diseases: evidences, mechanisms, and perspectives. Toxicol Appl Pharmacol. 2013 Apr 15;268(2):157-77. doi: 10.1016/j.taap.2013.01.025. Epub 2013 Feb 9.
PubMed 23402800Jochmanova I, Lazurova Z, Rudnay M, Bacova I, Marekova M, Lazurova I. Environmental estrogen bisphenol A and autoimmunity. Lupus. 2015 Apr;24(4-5):392-9. doi: 10.1177/0961203314560205.
PubMed 25801882Liska D, Lyon M, Jones DS. Detoxification and biotransformational imbalances. Explore (NY). 2006 Mar;2(2):122-40. doi: 10.1016/j.explore.2005.12.009. No abstract available.
PubMed 16781626Polanska K, Jurewicz J, Hanke W. Review of current evidence on the impact of pesticides, polychlorinated biphenyls and selected metals on attention deficit / hyperactivity disorder in children. Int J Occup Med Environ Health. 2013 Mar;26(1):16-38. doi: 10.2478/s13382-013-0073-7. Epub 2013 Mar 22.
PubMed 23526196Hodges RE, Minich DM. Modulation of Metabolic Detoxification Pathways Using Foods and Food-Derived Components: A Scientific Review with Clinical Application. J Nutr Metab. 2015;2015:760689. doi: 10.1155/2015/760689. Epub 2015 Jun 16.
PubMed 26167297Proudfoot AT, Krenzelok EP, Vale JA. Position Paper on urine alkalinization. J Toxicol Clin Toxicol. 2004;42(1):1-26. doi: 10.1081/clt-120028740.
PubMed 15083932Berardi JM, Logan AC, Rao AV. Plant based dietary supplement increases urinary pH. J Int Soc Sports Nutr. 2008 Nov 6;5:20. doi: 10.1186/1550-2783-5-20.
PubMed 18990209Konig D, Muser K, Dickhuth HH, Berg A, Deibert P. Effect of a supplement rich in alkaline minerals on acid-base balance in humans. Nutr J. 2009 Jun 10;8:23. doi: 10.1186/1475-2891-8-23.
PubMed 19515242Minich DM, Bland JS. Acid-alkaline balance: role in chronic disease and detoxification. Altern Ther Health Med. 2007 Jul-Aug;13(4):62-5.
PubMed 17658124Griendling KK, Touyz RM, Zweier JL, Dikalov S, Chilian W, Chen YR, Harrison DG, Bhatnagar A; American Heart Association Council on Basic Cardiovascular Sciences. Measurement of Reactive Oxygen Species, Reactive Nitrogen Species, and Redox-Dependent Signaling in the Cardiovascular System: A Scientific Statement From the American Heart Association. Circ Res. 2016 Aug 19;119(5):e39-75. doi: 10.1161/RES.0000000000000110. Epub 2016 Jul 14.
PubMed 27418630Zweier JL, Duke SS, Kuppusamy P, Sylvester JT, Gabrielson EW. Electron paramagnetic resonance evidence that cellular oxygen toxicity is caused by the generation of superoxide and hydroxyl free radicals. FEBS Lett. 1989 Jul 31;252(1-2):12-6. doi: 10.1016/0014-5793(89)80881-6.
PubMed 2547649Pastore A, Federici G, Bertini E, Piemonte F. Analysis of glutathione: implication in redox and detoxification. Clin Chim Acta. 2003 Jul 1;333(1):19-39. doi: 10.1016/s0009-8981(03)00200-6.
PubMed 12809732Lee DH, Blomhoff R, Jacobs DR Jr. Is serum gamma glutamyltransferase a marker of oxidative stress? Free Radic Res. 2004 Jun;38(6):535-9. doi: 10.1080/10715760410001694026.
PubMed 15346644
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standard Process's SP Detox Balance Dietary Supplements on Metabolic Detoxification
- ClinicalTrials.gov ID
- NCT06061289
- Acronym / sponsor ID
- SP-016
- Conditions
- Detoxification Response
- Keywords
- Detoxification, Whole Food Vitamins, Glutathione, liver, antioxidants, SOD, GST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwestern Health Sciences University
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 27 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and healthy diet | No intervention | –The healthy diet education session included a PowerPoint presentation on healthy dietary guidelines and sample recipes of healthy meals. |
| Detox | Experimental | Dietary Supplement: SP Detox ProgramThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- Prohibited Medications, Supplements or Herbal Products
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP Detox ProgramThe 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 | Dietary supplement | Detox |
Primary outcome
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.
8 secondary outcomes
Total Serum Antioxidants
Time frame: 28 days
Oxidative Stress
Time frame: 28 days
Detoxification Enzyme Activity - SOD
Time frame: 28 days
Detoxification Enzyme Activity - GST
Time frame: 28 days
Urinary Detox marker
Time frame: 28 days
Hepatic detox marker -1
Time frame: 28 days
Hepatic detox marker -2
Time frame: 28 days
Total Glutathione
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 22315626Sears ME, Genuis SJ. Environmental determinants of chronic disease and medical approaches: recognition, avoidance, supportive therapy, and detoxification. J Environ Public Health. 2012;2012:356798. doi: 10.1155/2012/356798. Epub 2012 Jan 19.
- Background: PubMed 33488302Bonakdar RA, Sweeney M, Dalhoumi S, Adair V, Garvey C, Hodge T, Herrala L, Barbee A, Case C, Kearney J, Smith K, Hwang J. Detoxification Enhanced Lifestyle Intervention Targeting Endotoxemia (DELITE) in the Setting of Obesity and Pain: Results of a Pilot Group Intervention. Integr Med (Encinitas). 2020 Oct;19(5):16-28.
- Background: PubMed 23402800Mostafalou S, Abdollahi M. Pesticides and human chronic diseases: evidences, mechanisms, and perspectives. Toxicol Appl Pharmacol. 2013 Apr 15;268(2):157-77. doi: 10.1016/j.taap.2013.01.025. Epub 2013 Feb 9.
- Background: PubMed 25801882Jochmanova I, Lazurova Z, Rudnay M, Bacova I, Marekova M, Lazurova I. Environmental estrogen bisphenol A and autoimmunity. Lupus. 2015 Apr;24(4-5):392-9. doi: 10.1177/0961203314560205.
- Background: PubMed 16781626Liska D, Lyon M, Jones DS. Detoxification and biotransformational imbalances. Explore (NY). 2006 Mar;2(2):122-40. doi: 10.1016/j.explore.2005.12.009. No abstract available.
- Background: PubMed 23526196Polanska K, Jurewicz J, Hanke W. Review of current evidence on the impact of pesticides, polychlorinated biphenyls and selected metals on attention deficit / hyperactivity disorder in children. Int J Occup Med Environ Health. 2013 Mar;26(1):16-38. doi: 10.2478/s13382-013-0073-7. Epub 2013 Mar 22.
- Background: PubMed 26167297Hodges RE, Minich DM. Modulation of Metabolic Detoxification Pathways Using Foods and Food-Derived Components: A Scientific Review with Clinical Application. J Nutr Metab. 2015;2015:760689. doi: 10.1155/2015/760689. Epub 2015 Jun 16.
- Background: PubMed 15083932Proudfoot AT, Krenzelok EP, Vale JA. Position Paper on urine alkalinization. J Toxicol Clin Toxicol. 2004;42(1):1-26. doi: 10.1081/clt-120028740.
- Background: PubMed 18990209Berardi JM, Logan AC, Rao AV. Plant based dietary supplement increases urinary pH. J Int Soc Sports Nutr. 2008 Nov 6;5:20. doi: 10.1186/1550-2783-5-20.
- Background: PubMed 19515242Konig D, Muser K, Dickhuth HH, Berg A, Deibert P. Effect of a supplement rich in alkaline minerals on acid-base balance in humans. Nutr J. 2009 Jun 10;8:23. doi: 10.1186/1475-2891-8-23.
- Background: PubMed 17658124Minich DM, Bland JS. Acid-alkaline balance: role in chronic disease and detoxification. Altern Ther Health Med. 2007 Jul-Aug;13(4):62-5.
- Background: PubMed 27418630Griendling KK, Touyz RM, Zweier JL, Dikalov S, Chilian W, Chen YR, Harrison DG, Bhatnagar A; American Heart Association Council on Basic Cardiovascular Sciences. Measurement of Reactive Oxygen Species, Reactive Nitrogen Species, and Redox-Dependent Signaling in the Cardiovascular System: A Scientific Statement From the American Heart Association. Circ Res. 2016 Aug 19;119(5):e39-75. doi: 10.1161/RES.0000000000000110. Epub 2016 Jul 14.
- Urine pH testLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chinmayee Panda, PhD principal investigator
Standard Process Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SP Detox Program in people with Detoxification Response, run by Standard Process Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Promis Global 10 (Self- reported Wellness) Questionnaire (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061289, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.