HealthyNCT05877365
Effects of 21-day Purification Program on Healthy Adults
A study testing Standard Process 21-Day Purification Program in people with Healthy, run by Standard Process Inc. at 1 site in United States.
Trial summary
This is a study to assess the impact of Standard Process's 21-Day Purification Program on metabolic health. Participants will be given the opportunity to consume the complex combination of vitamins, minerals, and antioxidants that comprise the 21-Day Guided Purification Program by Standard Process. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Standard Process 21-Day Purification Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 15 Jan 2024
- 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
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee.
- Willingness to comply with study protocol for 58 days
- Willingness to come and provide samples on all 4 study visits
- No allergy to any study products (a complete list of what supplements will assist is provided below))
- Subject is >18 years of age
- Subject 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
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- If on a chronic medication (that does not result in exclusion), subject has been on stable dose for at least two months prior to screening visit
- Subject 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
- Willingness to stay compliant for 22 days and not participate in another research 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 in the preceding 4 weeks and for duration of study [examples- statins, cholesterol absorption inhibitors like Ezetimibe (Zetia), PCSK9 inhibitors like Alirocumab (Praluent), Evolocumab (Repatha) etc.]
- The use of anticoagulant medications in the preceding 4 weeks and for duration of study [Examples: apixaban (Eliquis), betrixaban (Bevyxxa), edoxaban (Savaysa), and rivaroxaban (Xarelto) etc.]
Show all 17Show fewer
- Pregnant and nursing women are excluded from participation and women of childbearing age expecting to be pregnant soon will be excluded from the study
- 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 like high TG levels >150 mg/DL for example
- Substance Use - Use of ethanol within 24 hours of the evaluation visits (all 4 visits)
- 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
Keiser University Spine Care Clinic
West Palm Beach, Florida, 33411
About this study
Official title: Effects of Standard Process's 21-day Guided Purification Program on Metabolic Health in College Setting
This is a study to assess the impact of Standard Process's 21-Day Purification Program on metabolic health. Participants will be given the opportunity to consume the complex combination of vitamins, minerals, and antioxidants that comprise the 21-Day Guided Purification Program by Standard Process.
Read the detailed description
Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load we are exposed to daily may take a toll on our physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the human body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality.
- Conditions
- Healthy
- Being tested
- Standard Process 21-Day Purification Program
- Keywords
- Purification, Whole Food Vitamins, Detoxification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Process 21-Day Purification ProgramDietary supplement
Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load humans are exposed to daily may take a toll on physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality.
| Study group | Role | What they receive |
|---|---|---|
| Diet Only | No intervention | Following the same diet as the Purification group |
| Purification | Experimental | Following a diet along with whole food based supplementation Receives: Dietary Supplement: Standard Process 21-Day Purification Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Porphyrins in Urine
Using a kit, urinary porphyrins will be measured.
Measured: 58 days
Secondary outcomes (4)
Changes in GGT
A blood draw will be performed to evaluate gamma-glutamyl transferase (GGT) levels
Measured: 58 days
Changes in GST
A blood draw will be performed to evaluate Glutathione S-Transferase (GST) levels
Measured: 58 days
Questionnaire
PROMIS Global 10 Health Questionnaire will be used for the participant to evaluate their own health on a scale from 1-5.
Measured: 58 days
Changes in Weight
Participants will be weighed at each visit to help evaluate health
Measured: 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 Jun 2023
- Primary completion31 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- diet only vs whole food supplement based intervention
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Keiser University College of Chiropractic Medicine
- Responsible party
- Sponsor
- Investigators
- Chinmayee Panda, PhD, Principal investigator, Standard Process Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877365
- Sponsor's protocol ID
- SP-019-2
- Status last verified
- Nov 2024
- First submitted
- 10 Mar 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 22315626Liska DJ. The detoxification enzyme systems. Altern Med Rev. 1998 Jun;3(3):187-98.
PubMed 9630736Liska 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 16781626Hodges 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 26167297Griendling 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 15346644Chen CA, Wang TY, Varadharaj S, Reyes LA, Hemann C, Talukder MA, Chen YR, Druhan LJ, Zweier JL. S-glutathionylation uncouples eNOS and regulates its cellular and vascular function. Nature. 2010 Dec 23;468(7327):1115-8. doi: 10.1038/nature09599.
PubMed 21179168Varadharaj S, Kelly OJ, Khayat RN, Kumar PS, Ahmed N, Zweier JL. Role of Dietary Antioxidants in the Preservation of Vascular Function and the Modulation of Health and Disease. Front Cardiovasc Med. 2017 Nov 1;4:64. doi: 10.3389/fcvm.2017.00064. eCollection 2017.
PubMed 29164133Kim JA, Kim JY, Kang SW. Effects of the Dietary Detoxification Program on Serum gamma-glutamyltransferase, Anthropometric Data and Metabolic Biomarkers in Adults. J Lifestyle Med. 2016 Sep;6(2):49-57. doi: 10.15280/jlm.2016.6.2.49. Epub 2016 Sep 30.
PubMed 27924283Brewster MA. Biomarkers of xenobiotic exposures. Ann Clin Lab Sci. 1988 Jul-Aug;18(4):306-17.
PubMed 3044268Bonakdar 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 33488302Panda C, Kruse R, Williams K, Nance B, Gudavalli M, Pourafshar S, Metzger B, Komarnytsky S. Metabolic reset purification program improves antioxidant balance and gut microbiome in individuals transitioning to a healthier diet. Front Nutr. 2025 Aug 11;12:1621709. doi: 10.3389/fnut.2025.1621709. eCollection 2025.
PubMed 40860479
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standard Process's 21-day Guided Purification Program on Metabolic Health in College Setting
- ClinicalTrials.gov ID
- NCT05877365
- Acronym / sponsor ID
- SP-019-2
- Conditions
- Healthy
- Keywords
- Purification, Whole Food Vitamins, Detoxification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Collaborators
- Keiser University College of Chiropractic Medicine
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 26 May 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.
This is a study to assess the impact of Standard Process's 21-Day Purification Program on metabolic health. Participants will be given the opportunity to consume the complex combination of vitamins, minerals, and antioxidants that comprise the 21-Day Guided Purification Program by Standard Process.
Detailed description
Purification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load we are exposed to daily may take a toll on our physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the human body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- diet only vs whole food supplement based intervention
| Arm | Type | Receives |
|---|---|---|
| Diet Only | No intervention | –Following the same diet as the Purification group |
| Purification | Experimental | Dietary Supplement: Standard Process 21-Day Purification ProgramFollowing a diet along with whole food based supplementation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee.
- Willingness to comply with study protocol for 58 days
- Willingness to come and provide samples on all 4 study visits
- No allergy to any study products (a complete list of what supplements will assist is provided below))
- Subject is >18 years of age
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
- 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)
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 |
|---|---|---|
| Standard Process 21-Day Purification ProgramPurification, also known as detoxification, may help remove natural toxins from the body, while maintaining a healthy weight. The toxin load humans are exposed to daily may take a toll on physical and emotional well-being. Internally, human bodies produce waste byproducts because of normal metabolic function. Although the body is designed to rid itself of these toxins naturally, it can become overburdened. Purification may offer the body additional support to expel these toxins and manage weight, which is important to maintaining health and vitality. | Dietary supplement | Purification |
Primary outcome
Porphyrins in Urine
Time frame: 58 days
Using a kit, urinary porphyrins will be measured.
4 secondary outcomes
Changes in GGT
Time frame: 58 days
Changes in GST
Time frame: 58 days
Questionnaire
Time frame: 58 days
Changes in Weight
Time frame: 58 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 14 Nov 2024.
- 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 9630736Liska DJ. The detoxification enzyme systems. Altern Med Rev. 1998 Jun;3(3):187-98.
- 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 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 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.
- Background: PubMed 2547649Zweier 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.
- Background: PubMed 12809732Pastore 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.
- Background: PubMed 15346644Lee 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.
- Background: PubMed 21179168Chen CA, Wang TY, Varadharaj S, Reyes LA, Hemann C, Talukder MA, Chen YR, Druhan LJ, Zweier JL. S-glutathionylation uncouples eNOS and regulates its cellular and vascular function. Nature. 2010 Dec 23;468(7327):1115-8. doi: 10.1038/nature09599.
- Background: PubMed 29164133Varadharaj S, Kelly OJ, Khayat RN, Kumar PS, Ahmed N, Zweier JL. Role of Dietary Antioxidants in the Preservation of Vascular Function and the Modulation of Health and Disease. Front Cardiovasc Med. 2017 Nov 1;4:64. doi: 10.3389/fcvm.2017.00064. eCollection 2017.
- Background: PubMed 27924283Kim JA, Kim JY, Kang SW. Effects of the Dietary Detoxification Program on Serum gamma-glutamyltransferase, Anthropometric Data and Metabolic Biomarkers in Adults. J Lifestyle Med. 2016 Sep;6(2):49-57. doi: 10.15280/jlm.2016.6.2.49. Epub 2016 Sep 30.
- Background: PubMed 3044268Brewster MA. Biomarkers of xenobiotic exposures. Ann Clin Lab Sci. 1988 Jul-Aug;18(4):306-17.
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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 Standard Process 21-Day Purification Program in people with Healthy, 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 9 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 14 Nov 2024. 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?
Porphyrins in Urine (time frame: 58 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 NCT05877365, which also lists 14 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 14 Nov 2024.