Clinical trial NCT04525456: Immune Responses With Reduxium
Official title: Changes in the Immune Responses With Reduxium in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Tolerance
Viral Infection
Keywords: Antibody
Immunophenotyping
Immune cells
Lead sponsor: Ogevity Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National University of Singapore
First posted: 2020-08-25
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-centre, one-arm, prospective study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
timeFrame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
measure: Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
timeFrame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
measure: Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
measure: Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
timeFrame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
measure: Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Renal Panel (Urea) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
measure: Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
timeFrame: Baseline and week 8 post-baseline
Secondary outcomes:
measure: Number of Adverse Events After Reduxium Intake
timeFrame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore - The N.1 Institute for Health
city: Singapore
country: Singapore
facility: National University of Singapore - Yong Loo Lin School of Medicine
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. doi: 10.1093/ajcn/66.2.460S.
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. doi: 10.1159/000107673. Epub 2007 Aug 28.
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. doi: 10.1086/378587. Epub 2003 Aug 28.
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. doi: 10.1086/381535. Epub 2004 Feb 4.