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Immune Responses With Reduxium

Primary Purpose

Immune Tolerance, Viral Infection

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Reduxium
Sponsored by
Ogevity Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Tolerance focused on measuring Antibody, Immunophenotyping, Immune cells

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National University of Singapore - The N.1 Institute for Health
  • National University of Singapore - Yong Loo Lin School of Medicine
  • National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduxium

Arm Description

1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days

Outcomes

Primary Outcome Measures

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
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
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
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
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Sodium blood tests
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Potassium blood tests
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Urea blood tests
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Creatinine blood tests
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
AST blood tests
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
ALT blood tests
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Albumin blood tests
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
ALP blood tests
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Bilirubin blood tests
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
LDH blood tests

Secondary Outcome Measures

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

Full Information

First Posted
June 29, 2020
Last Updated
May 26, 2022
Sponsor
Ogevity Therapeutics, Inc.
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04525456
Brief Title
Immune Responses With Reduxium
Official Title
Changes in the Immune Responses With Reduxium in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ogevity Therapeutics, Inc.
Collaborators
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Tolerance, Viral Infection
Keywords
Antibody, Immunophenotyping, Immune cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-centre, one-arm, prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduxium
Arm Type
Experimental
Arm Description
1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Reduxium
Intervention Description
Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Primary Outcome Measure Information:
Title
Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Description
Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies
Time Frame
Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Title
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
Description
Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies
Time Frame
Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Title
Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
Description
Blood tests of monocytes subsets utilising groups of labelled antibodies
Time Frame
Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Title
Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
Description
Blood tests of NK cell subsets utilising groups of labelled antibodies
Time Frame
Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Title
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Description
Sodium blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Description
Potassium blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Description
Urea blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Description
Creatinine blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
Description
AST blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
Description
ALT blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Description
Albumin blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
Description
ALP blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Description
Bilirubin blood tests
Time Frame
Baseline and week 8 post-baseline
Title
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
Description
LDH blood tests
Time Frame
Baseline and week 8 post-baseline
Secondary Outcome Measure Information:
Title
Number of Adverse Events After Reduxium Intake
Description
To analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events
Time Frame
Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
National University of Singapore - The N.1 Institute for Health
City
Singapore
ZIP/Postal Code
117456
Country
Singapore
Facility Name
National University of Singapore - Yong Loo Lin School of Medicine
City
Singapore
ZIP/Postal Code
117597
Country
Singapore
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available
Citations:
PubMed Identifier
9250133
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.
Results Reference
background
PubMed Identifier
17726308
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.
Results Reference
background
PubMed Identifier
12955652
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.
Results Reference
background
PubMed Identifier
14767818
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.
Results Reference
background

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Immune Responses With Reduxium

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