CompletedNCT04525456Updated May 27, 2022Results posted

Immune Responses With Reduxium

An interventional study of Reduxium in Immune Tolerance and Viral Infection, sponsored by Ogevity Therapeutics, Inc.. Completed at 3 sites in Singapore. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-27.

Sponsored by Ogevity Therapeutics, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 21 Years to 50 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Immune Tolerance
Viral Infection

Browse trials for

Virus Diseases 914

Keywords

Antibody
Immunophenotyping
Immune cells

In context

Virus Diseases

914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.

This study's enrollment of 20 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.

Browse Virus Diseases studies →

Lead sponsor

This is the only study on the registry with Ogevity Therapeutics, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
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
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
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
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
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
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Sodium blood tests
Time frame: Baseline and week 8 post-baseline
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Potassium blood tests
Time frame: Baseline and week 8 post-baseline
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Urea blood tests
Time frame: Baseline and week 8 post-baseline
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Creatinine blood tests
Time frame: Baseline and week 8 post-baseline
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
AST blood tests
Time frame: Baseline and week 8 post-baseline
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
ALT blood tests
Time frame: Baseline and week 8 post-baseline
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Albumin blood tests
Time frame: Baseline and week 8 post-baseline
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
ALP blood tests
Time frame: Baseline and week 8 post-baseline
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Bilirubin blood tests
Time frame: Baseline and week 8 post-baseline
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
LDH blood tests
Time frame: Baseline and week 8 post-baseline

Secondary outcomes

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
Time frame: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline

Results

Posted May 27, 2022

Participant flow

Recruitment happened between October 7, 2020 and January 27, 2021 at National University Hospital (NUH) in Singapore.

Participant flow — Overall Study
Milestone	Reduxium
Started	20
Completed	20
Not completed	0

Outcome measures

PrimaryImmune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake

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
Reported as:: Mean · percentage of cells

Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
percentage of cells	Reduxium
Baseline - Total T cells	60.53 ± 9.24
Week 3 - Total T cells	60 ± 10.27
Week 4 - Total T cells	59.29 ± 9.44
Week 5 - Total T cells	56.52 ± 11.88
Week 6 - Total T cells	57.44 ± 12.75
Week 7 - Total T cells	58.54 ± 10.23
Week 8 - Total T cells	58.54 ± 11.09
Baseline - Total CD8 (cluster of differentiation 8)+ T cells	34.08 ± 8.98
Week 3 - Total CD8+ T cells	35.08 ± 8.71
Week 4 - Total CD8+ T cells	35.08 ± 9.19
Week 5 - Total CD8+ T cells	34.46 ± 9.34
Week 6 - Total CD8+ T cells	35.30 ± 8.88
Week 7 - Total CD8+ T cells	34.68 ± 9.93
Week 8 - Total CD8+ T cells	34.49 ± 9.56
Baseline - Exhausted CD8+ T cells	1.81 ± 1.15
Week 3 - Exhausted CD8+ T cells	2.06 ± 1.42
Week 4 - Exhausted CD8+ T cells	2.03 ± 1.44
Week 5 - Exhausted CD8+ T cells	1.61 ± 1.00
Week 6 - Exhausted CD8+ T cells	1.78 ± 1.18
Week 7 - Exhausted CD8+ T cells	2.00 ± 1.36
Week 8 - Exhausted CD8+ T cells	1.88 ± 1.08
Baseline - Total CD4+ cells	54.16 ± 10.98
Week 3 - Total CD4+ cells	53.57 ± 12.13
Week 4 - Total CD4+ cells	53.97 ± 11.34
Week 5 - Total CD4+ cells	53.34 ± 12.22
Week 6 - Total CD4+ cells	53.58 ± 10.85
Week 7 - Total CD4+ cells	54.79 ± 12.30
Week 8 - Total CD4+ cells	54.49 ± 12.54
Baseline - Exhausted CD4+ T cells	11.30 ± 5.46
Week 3 -Exhausted CD4+ T cells	11.93 ± 5.39
Week 4 -Exhausted CD4+ T cells	11.15 ± 4.49
Week 5 -Exhausted CD4+ T cells	10.87 ± 5.96
Week 6 -Exhausted CD4+ T cells	10.65 ± 5.15
Week 7 -Exhausted CD4+ T cells	11.59 ± 5.76
Week 8 -Exhausted CD4+ T cells	11.27 ± 4.90
Baseline -Regulatory T cells (Tregs)	6.32 ± 1.39
Week 3 - Regulatory T cells (Tregs)	6.95 ± 1.50
Week 4 - Regulatory T cells (Tregs)	7.34 ± 1.80
Week 5 - Regulatory T cells (Tregs)	6.49 ± 1.93
Week 6 - Regulatory T cells (Tregs)	6.88 ± 1.90
Week 7 - Regulatory T cells (Tregs)	6.81 ± 1.90
Week 8 - Regulatory T cells (Tregs)	7.05 ± 1.53
Baseline - chemokine receptor 3 (CXCR3)-Chemokine receptor 6 (CCR6)+	1.02 ± 1.45
Week 3 - CXCR3-CCR6+	1.24 ± 2.24
Week 4 - CXCR3-CCR6+	1.09 ± 1.81
Week 5 - CXCR3-CCR6+	1.60 ± 2.23
Week 6 - CXCR3-CCR6+	1.34 ± 1.94
Week 7 - CXCR3-CCR6+	1.32 ± 1.92
Week 8 - CXCR3-CCR6+	1.09 ± 1.63
Baseline - T helper (Th) 1/Th17 cells	7.17 ± 5.19
Week 3 - Th1/Th17 cells	6.02 ± 5.48
Week 4 - Th1/Th17 cells	5.33 ± 5.12
Week 5 - Th1/Th17 cells	4.55 ± 3.92
Week 6 - Th1/Th17 cells	4.57 ± 3.67
Week 7 - Th1/Th17 cells	4.70 ± 3.69
Week 8 - Th1/Th17 cells	4.56 ± 3.80
Baseline - Th1 cells	48.63 ± 24.93
Week 3 - Th1 cells	45.58 ± 30.23
Week 4 - Th1 cells	44.85 ± 31.63
Week 5 - Th1 cells	44.15 ± 31.98
Week 6 - Th1 cells	47.80 ± 33.09
Week 7 - Th1 cells	47.30 ± 30.82
Week 8 - Th1 cells	47.58 ± 32.12
Baseline - Th17 cells	1.28 ± 0.80
Week 3 - Th17 cells	1.16 ± 0.91
Week 4 - Th17 cells	1.21 ± 0.99
Week 5 - Th17 cells	1.19 ± 1.07
Week 6 - Th17 cells	1.16 ± 1.16
Week 7 - Th17 cells	1.14 ± 0.84
Week 8 - Th17 cells	1.24 ± 1.22
Baseline - Th2 cells	2.86 ± 1.75
Week 3 - Th2 cells	3.67 ± 2.28
Week 4 - Th2 cells	3.58 ± 2.13
Week 5 - Th2 cells	3.46 ± 1.97
Week 6 - Th2 cells	3.56 ± 1.94
Week 7 - Th2 cells	3.82 ± 2.33
Week 8 - Th2 cells	4.05 ± 2.23
Baseline - T follicular helper cells (Tfh)	13.75 ± 2.67
Week 3 - T follicular helper cells (Tfh)	12.75 ± 3.52
Week 4 - T follicular helper cells (Tfh)	12.02 ± 3.48
Week 5 - T follicular helper cells (Tfh)	12.40 ± 3.83
Week 6 - T follicular helper cells (Tfh)	12.22 ± 3.16
Week 7 - T follicular helper cells (Tfh)	12.33 ± 3.50
Week 8 - T follicular helper cells (Tfh)	11.58 ± 4.92
Baseline - Activated Tfh (Inducible T-cell Costimulator (ICOS+))	0.50 ± 0.24
Week 3 - Activated Tfh (ICOS+)	0.45 ± 0.24
Week 4 - Activated Tfh (ICOS+)	0.44 ± 0.27
Week 5 - Activated Tfh (ICOS+)	0.38 ± 0.22
Week 6 - Activated Tfh (ICOS+)	0.40 ± 0.23
Week 7 - Activated Tfh (ICOS+)	0.47 ± 0.26
Week 8 - Activated Tfh (ICOS+)	0.48 ± 0.32
Baseline - Activated Tfh (Programmed cell death protein 1 (PD-1+))	2.30 ± 0.84
Week 3 - Activated Tfh (PD-1+)	2.25 ± 0.88
Week 4 - Activated Tfh (PD-1+)	2.08 ± 1.01
Week 5 - Activated Tfh (PD-1+)	2.01 ± 0.85
Week 6 - Activated Tfh (PD-1+)	2.08 ± 0.85
Week 7 - Activated Tfh (PD-1+)	2.20 ± 0.91
Week 8 - Activated Tfh (PD-1+)	2.18 ± 1.16
Baseline - Activated Tfh (ICOS+PD-1+)	1.18 ± 0.67
Week 3 - Activated Tfh (ICOS+PD-1+)	1.17 ± 0.58
Week 4 - Activated Tfh (ICOS+PD-1+)	1.18 ± 0.60
Week 5 - Activated Tfh (ICOS+PD-1+)	1.00 ± 0.49
Week 6 - Activated Tfh (ICOS+PD-1+)	1.08 ± 0.46
Week 7 - Activated Tfh (ICOS+PD-1+)	1.32 ± 0.89
Week 8 - Activated Tfh (ICOS+PD-1+)	1.33 ± 0.84

PrimaryImmune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake

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
Reported as:: Mean · percentage of cells

Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake
percentage of cells	Reduxium
Baseline - Total B cells	17.44 ± 6.89
Week 3 - Total B cells	21.09 ± 12.68
Week 4 - Total B cells	18.64 ± 7.32
Week 5 - Total B cells	19.84 ± 10.33
Week 6 - Total B cells	20.70 ± 9.28
Week 7 - Total B cells	20.48 ± 8.92
Week 8 - Total B cells	22.05 ± 10.99
Baseline - Memory B cells (MBCs)	7.47 ± 3.18
Week 3 - Memory B cells (MBCs)	7.34 ± 3.08
Week 4 - Memory B cells (MBCs)	7.63 ± 3.91
Week 5 - Memory B cells (MBCs)	7.44 ± 3.46
Week 6 - Memory B cells (MBCs)	7.17 ± 2.93
Week 7 - Memory B cells (MBCs)	7.53 ± 3.38
Week 8 - Memory B cells (MBCs)	7.66 ± 3.68
Baseline - Classical MBCs	1.24 ± 0.78
Week 3 - Classical MBCs	0.96 ± 0.55
Week 4 - Classical MBCs	1.06 ± 0.69
Week 5 - Classical MBCs	1.15 ± 0.60
Week 6 - Classical MBCs	0.90 ± 0.48
Week 7 - Classical MBCs	0.91 ± 0.53
Week 8 - Classical MBCs	0.93 ± 0.57
Baseline - Activated MBCs	6.28 ± 2.78
Week 3 - Activated MBCs	6.37 ± 2.79
Week 4 - Activated MBCs	6.59 ± 3.69
Week 5 - Activated MBCs	6.46 ± 3.15
Week 6 - Activated MBCs	6.25 ± 2.69
Week 7 - Activated MBCs	6.61 ± 3.09
Week 8 - Activated MBCs	6.71 ± 3.38
Baseline - Tissue-like MBCs	1.27 ± 0.90
Week 3 - Tissue-like MBCs	1.01 ± 0.62
Week 4 - Tissue-like MBCs	1.09 ± 0.69
Week 5 - Tissue-like MBCs	1.04 ± 0.63
Week 6 - Tissue-like MBCs	0.96 ± 0.56
Week 7 - Tissue-like MBCs	0.95 ± 0.54
Week 8 - Tissue-like MBCs	0.99 ± 0.60
Baseline - Switched B cells	1.58 ± 1.24
Week 3 - Switched B cells	1.23 ± 1.21
Week 4 - Switched B cells	1.39 ± 1.21
Week 5 - Switched B cells	1.33 ± 1.12
Week 6 - Switched B cells	1.17 ± 1.06
Week 7 - Switched B cells	1.35 ± 1.13
Week 8 - Switched B cells	1.75 ± 2.15
Baseline - Unswitched B cells	7.96 ± 3.37
Week 3 - Unswitched B cells	7.76 ± 3.26
Week 4 - Unswitched B cells	8.16 ± 4.27
Week 5 - Unswitched B cells	7.90 ± 3.60
Week 6 - Unswitched B cells	7.58 ± 3.07
Week 7 - Unswitched B cells	7.98 ± 3.52
Week 8 - Unswitched B cells	8.11 ± 3.83
Baseline - Naïve B cells	4.74 ± 2.61
Week 3 - Naïve B cells	5.13 ± 3.00
Week 4 - Naïve B cells	5.02 ± 3.02
Week 5 - Naïve B cells	4.85 ± 3.07
Week 6 - Naïve B cells	4.97 ± 3.10
Week 7 - Naïve B cells	5.28 ± 3.18
Week 8 - Naïve B cells	5.55 ± 3.41
Baseline - Plasmablasts	5.38 ± 3.63
Week 3 - Plasmablasts	4.67 ± 3.79
Week 4 - Plasmablasts	4.85 ± 3.68
Week 5 - Plasmablasts	5.12 ± 3.89
Week 6 - Plasmablasts	4.66 ± 3.53
Week 7 - Plasmablasts	4.21 ± 3.08
Week 8 - Plasmablasts	4.33 ± 3.26
Baseline - Exhausted B cells	3.13 ± 1.83
Week 3 - Exhausted B cells	2.36 ± 1.48
Week 4 - Exhausted B cells	2.68 ± 1.88
Week 5 - Exhausted B cells	2.71 ± 1.50
Week 6 - Exhausted B cells	2.25 ± 1.22
Week 7 - Exhausted B cells	2.45 ± 1.33
Week 8 - Exhausted B cells	2.83 ± 2.31

PrimaryInnate 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

Time frame:: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Reported as:: Mean · percentage of cells

Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake
percentage of cells	Reduxium
Baseline - Non-classical monocytes	4.88 ± 3.41
Week 3 - Non-classical monocytes	2.50 ± 1.84
Week 4 - Non-classical monocytes	2.99 ± 2.01
Week 5 - Non-classical monocytes	2.94 ± 2.15
Week 6 - Non-classical monocytes	2.51 ± 2.04
Week 7 - Non-classical monocytes	2.73 ± 1.80
Week 8 - Non-classical monocytes	3.26 ± 1.68
Baseline - Intermediate monocytes	7.26 ± 7.17
Week 3 - Intermediate monocytes	4.00 ± 5.63
Week 4 - Intermediate monocytes	5.60 ± 5.60
Week 5 - Intermediate monocytes	5.79 ± 7.20
Week 6 - Intermediate monocytes	5.41 ± 6.23
Week 7 - Intermediate monocytes	6.08 ± 6.32
Week 8 - Intermediate monocytes	7.49 ± 7.31
Baseline - Classical monocytes	78.92 ± 11.78
Week 3 - Classical monocytes	84.86 ± 8.92
Week 4 - Classical monocytes	83.27 ± 9.06
Week 5 - Classical monocytes	83.68 ± 10.25
Week 6 - Classical monocytes	85.39 ± 8.31
Week 7 - Classical monocytes	84.87 ± 8.45
Week 8 - Classical monocytes	82.72 ± 10.86

PrimaryInnate 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

Time frame:: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Reported as:: Mean · percentage of cells

Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake
percentage of cells	Reduxium
CD16++CD56- - Baseline	0.89 ± 0.62
Week 3 - CD16++CD56-	0.91 ± 0.50
Week 4 - CD16++CD56-	0.99 ± 0.44
Week 5 - CD16++CD56-	0.83 ± 0.39
Week 6 - CD16++CD56-	1.02 ± 0.58
Week 7 - CD16++CD56-	1.24 ± 0.60
Week 8 - CD16++CD56-	1.34 ± 0.56
Baseline - CD16+CD56+	67.89 ± 13.20
Week 3 - CD16+CD56+	66.63 ± 15.26
Week 4 - CD16+CD56+	66.31 ± 15.48
Week 5 - CD16+CD56+	67.07 ± 15.67
Week 6 - CD16+CD56+	69.92 ± 13.13
Week 7 - CD16+CD56+	69.86 ± 10.90
Week 8 - CD16+CD56+	69.04 ± 13.01
Baseline - CD16+CD56++	0.94 ± 0.47
Week 3 - CD16+CD56++	1.09 ± 0.68
Week 4 - CD16+CD56++	0.96 ± 0.45
Week 5 - CD16+CD56++	0.90 ± 0.42
Week 6 - CD16+CD56++	1.08 ± 0.59
Week 7 - CD16+CD56++	1.06 ± 0.45
Week 8 - CD16+CD56++	1.23 ± 0.68
Baseline - CD16-CD56+	2.05 ± 1.01
Week 3 - CD16-CD56+	1.78 ± 0.98
Week 4 - CD16-CD56+	1.68 ± 0.69
Week 5 - CD16-CD56+	1.68 ± 0.84
Week 6 - CD16-CD56+	1.61 ± 0.73
Week 7 - CD16-CD56+	1.66 ± 0.73
Week 8 - CD16-CD56+	1.56 ± 0.84
Baseline - CD16-CD56++	2.98 ± 1.54
Week 3 - CD16-CD56++	2.90 ± 1.60
Week 4 - CD16-CD56++	2.66 ± 1.23
Week 5 - CD16-CD56++	2.61 ± 1.26
Week 6 - CD16-CD56++	2.84 ± 1.44
Week 7 - CD16-CD56++	2.67 ± 1.06
Week 8 - CD16-CD56++	3.16 ± 1.79

PrimaryRenal Panel (Sodium) After 2 Weeks of Reduxium Intake

Sodium blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · mmol/L

Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
mmol/L	Reduxium
Baseline	139.55 ± 1.43
Week 8	139.40 ± 1.59

PrimaryRenal Panel (Potassium) After 2 Weeks of Reduxium Intake

Potassium blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · mmol/L

Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
mmol/L	Reduxium
Baseline	4.26 ± 0.49
Week 8	4.54 ± 0.46

PrimaryRenal Panel (Urea) After 2 Weeks of Reduxium Intake

Urea blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · mmol/L

Renal Panel (Urea) After 2 Weeks of Reduxium Intake
mmol/L	Reduxium
Baseline	4.20 ± 1.45
Week 8	4.04 ± 1.08

PrimaryRenal Panel (Creatinine) After 2 Weeks of Reduxium Intake

Creatinine blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · umol/L

Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
umol/L	Reduxium
Baseline	69.05 ± 12.09
Week 8	68.85 ± 11.76

PrimaryLiver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake

AST blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · U/L

Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
U/L	Reduxium
Baseline	19.50 ± 3.35
Week 8	20.55 ± 4.15

PrimaryLiver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake

ALT blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · U/L

Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
U/L	Reduxium
Baseline	15.90 ± 7.66
Week 8	17.40 ± 9.45

PrimaryLiver Panel (Albumin) After 2 Weeks of Reduxium Intake

Albumin blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · g/L

Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
g/L	Reduxium
Baseline	42.80 ± 3.37
Week 8	42.95 ± 2.03

PrimaryLiver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake

ALP blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · U/L

Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
U/L	Reduxium
Baseline	62.90 ± 19.82
Week 8	59.90 ± 15.87

PrimaryLiver Panel (Bilirubin) After 2 Weeks of Reduxium Intake

Bilirubin blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · umol/L

Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
umol/L	Reduxium
Baseline	11.90 ± 4.09
Week 8	11.25 ± 3.50

PrimaryLiver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake

LDH blood tests

Time frame:: Baseline and week 8 post-baseline
Reported as:: Mean · U/L

Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
U/L	Reduxium
Baseline	310.80 ± 43.87
Week 8	377 ± 108.54

SecondaryNumber 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

Time frame:: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline
Reported as:: Number · adverse events

Number of Adverse Events After Reduxium Intake
adverse events	Reduxium
Number of Adverse Events After Reduxium Intake	0

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Reduxium	0/20 (0%)	0/20 (0%)	0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Reduxium
Mean	32.4 ± 5.4

Sex: Female, Male
Sex: Female, Male(Participants)	Reduxium
Female	14
Male	6

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Reduxium

Region of Enrollment
Region of Enrollment(Participants)	Reduxium
Singapore	20

Study locations

3 sites

National University of Singapore - The N.1 Institute for Health
Singapore, 117456, Singapore
National University of Singapore - Yong Loo Lin School of Medicine
Singapore, 117597, Singapore
National University Hospital
Singapore, 119074, Singapore

References and documents

Publications

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. PubMed 9250133 ↗
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. PubMed 17726308 ↗
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. PubMed 12955652 ↗
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. PubMed 14767818 ↗

Study documents

Study protocol · May 11, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There is no plan to make IPD available

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04525456
Lead sponsor: Ogevity Therapeutics, Inc.
Collaborators: National University of Singapore
Responsible party: Sponsor
First posted: Aug 25, 2020
Start date: Oct 7, 2020
Primary completion: Dec 15, 2020
Completion: Jan 27, 2021
Results posted: May 27, 2022
Last update: May 27, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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