Immune Responses With Reduxium

Viral Infection Clinical Trial

Official title:

Changes in the Immune Responses With Reduxium in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525456
• Other study ID #: 0101.2006.0101.0001
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: January 27, 2021

Study information

• Verified date: May 2022
• Source: Ogevity Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reduxium is a dietary supplement that provides immune support. This natural compound is orally-ingested in the form of droplets in water to boost the immune system and control inflammation. There is not enough data on the mechanism associated with the action of Reduxium or the extent of the immune response increase it produces. In this study, the investigators propose treating a group of healthy volunteers with Reduxium and investigate the utility of this approach in boosting the native and adaptive immune responses that correlate with immune protection. This may form the basis for a future study employing the product in infectious disease patients.

Description:

With the global population increasingly exposed to pandemic crises, permanent and expedient solutions are needed at an affordable cost. Vaccination is less than ideal as the virus is prone to a mutation that renders the previous generation of vaccine less effective. Epidemic and pandemic of viruses infection has become more common and affects both developed and less developed communities. Overcrowding and poor hygiene have been cited to be the major factors in these epidemics, but the host immune system and the ability of the human system to ward off virus infection is a factor less mentioned. Nutrition is a critical determinant of immune responses and malnutrition the most common cause of immunodeficiency worldwide. Protein-energy malnutrition is associated with a significant impairment of cell-mediated immunity, phagocyte function, complement system, secretory immunoglobulin A antibody concentrations, and cytokine production. Deficiency of single nutrients also results in altered immune responses: this is observed even when the deficiency state is relatively mild. Of the micronutrients, zinc; selenium; iron; copper; vitamins A, C, E, and B6; and folic acid have important influences on immune responses. Adequate intake of vitamins B6, folate, B12, C, E, and of selenium, zinc, copper, and iron supports a T helper cell (Th)1 cytokine-mediated immune response with sufficient production of proinflammatory cytokines, which maintains an effective immune response and avoids a shift to an anti-inflammatory Th2 cell-mediated immune response and an increased risk of extracellular infections. Supplementation with these micronutrients reverses the Th2 cell-mediated immune response to a proinflammatory Th1 cytokine-regulated response with enhanced innate immunity. Reduxium, a dietary supplement that provides immune support, is a low-cost candidate to boost immune response. Reduxium is a natural compound commercialised in the USA that helps restore homeostasis and controls inflammation. As no toxins or allergens are used, but purely food grade compounds, it is classified as a dietary supplement. Its current purpose is not to treat, diagnose, prevent or cure any disease, but it has immunomodulatory properties. Reduxium is manufactured using a proprietary reactor - a "biochemical cavitation mixer" that allows to create a "smart small molecule". The principal device belongs to the cavitation technology family and is used for the intensification of technological processes in liquid media (liquid processing, splitting of complex molecules, "cold" pasteurization, destruction of solid inclusions). The usage of this process technology enables compression of a set of molecules to 1/12th their original size. Its components are: Phosphoric Acid (58%), Microelement Complex (33.6%) (Zinc, Copper, Iron Pyrophosphate, Potassium, Calcium, Silica, Glycyrrhizic Acid (8.4%). The Microelement Complex is made up of a homogenized complex with special indication, pH =0.0008-0.4, waterless in the final composition.The complex molecules generated scan at the cellular level for the presence of pathogenic (bacterial, viral, fungal) etiologies by reading the characteristics of the electron proton (KNa) pump on the membrane. If these characteristics are violated, the supplement "enters" the cell. At the intra-cellular level, the supplement scans the cell in search of pathology; this "scanning process" is made on the basis of selectivity (healthy - do not touch/ill - induce apoptosis) through the mechanism of mitochondria activity. Specifically, the complex molecules start a cascade of biochemical processes (switching to mitochondria aerobic oxidation, restarting the methyl group with the "epigenetic" effects on DNA, apoptosis). It is unclear how and to which extent this mechanism contributes to innate immune activation following cellular damage and stress, or how it contributes to the adaptive immune response of T and B cells. The primary objective is to analyse the changes in the immune responses after two weeks of Reduxium intake.The secondary objective is to analyse the safety and tolerability of Reduxium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 27, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subjects of 21 - 50 years of age
• Normal blood pressure (BP <140/90 nnHg)
• Normal fasting glucose (<6mmol/L)
• Subjects must stop all supplement for 1 month prior to enrolment

Exclusion Criteria:

• Subjects with known history of lungs or cardiovascular disease
• History of previous pancreatitis
• Past or current history of malignancy
• Subjects with type 2 diabetes
• Past or current history of peptic ulcer disease
• Current pregnancy or breastfeeding

Related Conditions & MeSH terms

• Immune Tolerance
• Viral Infection
• Virus Diseases

Intervention

Dietary Supplement:
• Reduxium
Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	National University of Singapore - The N.1 Institute for Health	Singapore
Singapore	National University of Singapore - Yong Loo Lin School of Medicine	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Ogevity Therapeutics, Inc.	National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. Review. — View Citation

Cui W, Fan Y, Wu W, Zhang F, Wang JY, Ni AP. Expression of lymphocytes and lymphocyte subsets in patients with severe acute respiratory syndrome. Clin Infect Dis. 2003 Sep 15;37(6):857-9. Epub 2003 Aug 28. — View Citation

Li T, Qiu Z, Zhang L, Han Y, He W, Liu Z, Ma X, Fan H, Lu W, Xie J, Wang H, Deng G, Wang A. Significant changes of peripheral T lymphocyte subsets in patients with severe acute respiratory syndrome. J Infect Dis. 2004 Feb 15;189(4):648-51. Epub 2004 Feb 4. — View Citation

Wintergerst ES, Maggini S, Hornig DH. Contribution of selected vitamins and trace elements to immune function. Ann Nutr Metab. 2007;51(4):301-23. Epub 2007 Aug 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake	Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies	Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Primary	Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake	Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies	Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Primary	Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake	Blood tests of monocytes subsets utilising groups of labelled antibodies	Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Primary	Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake	Blood tests of NK cell subsets utilising groups of labelled antibodies	Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Primary	Renal Panel (Sodium) After 2 Weeks of Reduxium Intake	Sodium blood tests	Baseline and week 8 post-baseline
Primary	Renal Panel (Potassium) After 2 Weeks of Reduxium Intake	Potassium blood tests	Baseline and week 8 post-baseline
Primary	Renal Panel (Urea) After 2 Weeks of Reduxium Intake	Urea blood tests	Baseline and week 8 post-baseline
Primary	Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake	Creatinine blood tests	Baseline and week 8 post-baseline
Primary	Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake	AST blood tests	Baseline and week 8 post-baseline
Primary	Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake	ALT blood tests	Baseline and week 8 post-baseline
Primary	Liver Panel (Albumin) After 2 Weeks of Reduxium Intake	Albumin blood tests	Baseline and week 8 post-baseline
Primary	Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake	ALP blood tests	Baseline and week 8 post-baseline
Primary	Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake	Bilirubin blood tests	Baseline and week 8 post-baseline
Primary	Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake	LDH blood tests	Baseline and week 8 post-baseline
Secondary	Number of Adverse Events After Reduxium Intake	To analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events	Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline