Guided Metabolic Detox Program

NCT06061289 | Completed

• 1 other identifier: SP-016
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Detoxification Response

Keywords

Detoxification; Whole Food Vitamins; Glutathione; liver; antioxidants; SOD; GST

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total Serum Antioxidants

  28 days

• Oxidative Stress

  28 days

• Detoxification Enzyme Activity - SOD

  28 days

• Detoxification Enzyme Activity - GST

  28 days

• Urinary Detox marker

  28 days

Study Arms (2)

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.

Dietary Supplement: SP Detox Program

Interventions

SP Detox Program DIETARY_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

Detox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Standard Process Inc.: lead
• Northwestern Health Sciences University: collaborator

Study Sites (1)

De-Rusha Clinic, Northwestern Health Sciences University

Bloomington, Minnesota, 55431, United States

Location

Related Publications (24)

• 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.

  PMID: 22315626 BACKGROUND

• Bonakdar 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.

  PMID: 33488302 BACKGROUND

• Mostafalou 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.

  PMID: 23402800 BACKGROUND

• Jochmanova 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.

  PMID: 25801882 BACKGROUND

• Liska 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.

  PMID: 16781626 BACKGROUND

• Polanska 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.

  PMID: 23526196 BACKGROUND

• Hodges 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.

  PMID: 26167297 BACKGROUND

• Proudfoot AT, Krenzelok EP, Vale JA. Position Paper on urine alkalinization. J Toxicol Clin Toxicol. 2004;42(1):1-26. doi: 10.1081/clt-120028740.

  PMID: 15083932 BACKGROUND

• Berardi 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.

  PMID: 18990209 BACKGROUND

• Konig 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.

  PMID: 19515242 BACKGROUND

• Minich DM, Bland JS. Acid-alkaline balance: role in chronic disease and detoxification. Altern Ther Health Med. 2007 Jul-Aug;13(4):62-5.

  PMID: 17658124 BACKGROUND

• Griendling 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.

  PMID: 27418630 BACKGROUND

• Zweier 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.

  PMID: 2547649 BACKGROUND

• Pastore 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.

  PMID: 12809732 BACKGROUND

• Lee 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.

  PMID: 15346644 BACKGROUND

• Chen 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.

  PMID: 21179168 BACKGROUND

• Varadharaj 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.

  PMID: 29164133 BACKGROUND

• Yen CH, Tseng YH, Kuo YW, Lee MC, Chen HL. Long-term supplementation of isomalto-oligosaccharides improved colonic microflora profile, bowel function, and blood cholesterol levels in constipated elderly people--a placebo-controlled, diet-controlled trial. Nutrition. 2011 Apr;27(4):445-50. doi: 10.1016/j.nut.2010.05.012. Epub 2010 Jul 10.

  PMID: 20624673 BACKGROUND

• Chen HL, Lu YH, Lin JJ, Ko LY. Effects of isomalto-oligosaccharides on bowel functions and indicators of nutritional status in constipated elderly men. J Am Coll Nutr. 2001 Feb;20(1):44-9. doi: 10.1080/07315724.2001.10719013.

  PMID: 11294172 BACKGROUND

• Zhao ZY, Liang L, Fan X, Yu Z, Hotchkiss AT, Wilk BJ, Eliaz I. The role of modified citrus pectin as an effective chelator of lead in children hospitalized with toxic lead levels. Altern Ther Health Med. 2008 Jul-Aug;14(4):34-8.

  PMID: 18616067 BACKGROUND

• Zhang N, Huang C, Ou S. In vitro binding capacities of three dietary fibers and their mixture for four toxic elements, cholesterol, and bile acid. J Hazard Mater. 2011 Feb 15;186(1):236-9. doi: 10.1016/j.jhazmat.2010.10.120. Epub 2010 Nov 9.

  PMID: 21095057 BACKGROUND

• Eliaz I, Hotchkiss AT, Fishman ML, Rode D. The effect of modified citrus pectin on urinary excretion of toxic elements. Phytother Res. 2006 Oct;20(10):859-64. doi: 10.1002/ptr.1953.

  PMID: 16835878 BACKGROUND

• Cuervo A, Salazar N, Ruas-Madiedo P, Gueimonde M, Gonzalez S. Fiber from a regular diet is directly associated with fecal short-chain fatty acid concentrations in the elderly. Nutr Res. 2013 Oct;33(10):811-6. doi: 10.1016/j.nutres.2013.05.016. Epub 2013 Jul 26.

  PMID: 24074739 BACKGROUND

• Cline JC. Nutritional aspects of detoxification in clinical practice. Altern Ther Health Med. 2015 May-Jun;21(3):54-62.

  PMID: 26026145 BACKGROUND

Related Links

• Urine pH test

Study Officials

• Chinmayee Panda, PhD

  Standard Process Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: September 29, 2023
• Study Start: March 6, 2022
• Primary Completion: August 27, 2022
• Study Completion: September 30, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)