Immune Tolerance, Viral Infection
Conditions
Keywords
Antibody, Immunophenotyping, Immune cells
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.
Interventions
Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Sponsors
Study design
Intervention model description
single-centre, one-arm, prospective study
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | LDH blood tests |
| Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline | 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 | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline | 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 | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline | 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 | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline | Blood tests of NK cell subsets utilising groups of labelled antibodies |
| Renal Panel (Sodium) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | Sodium blood tests |
| Renal Panel (Potassium) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | Potassium blood tests |
| Renal Panel (Urea) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | Urea blood tests |
| Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | Creatinine blood tests |
| Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | AST blood tests |
| Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | ALT blood tests |
| Liver Panel (Albumin) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | Albumin blood tests |
| Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | ALP blood tests |
| Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake | Baseline and week 8 post-baseline | Bilirubin blood tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events After Reduxium Intake | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline | To analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events |
Countries
Singapore
Participant flow
Recruitment details
Recruitment happened between October 7, 2020 and January 27, 2021 at National University Hospital (NUH) in Singapore.
Participants by arm
| Arm | Count |
|---|---|
| Reduxium The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Reduxium | — |
|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 5.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Singapore | 20 Participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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
Population: healthy participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Total B cells | 17.44 percentage of cells | Standard Deviation 6.89 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Total B cells | 21.09 percentage of cells | Standard Deviation 12.68 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Total B cells | 18.64 percentage of cells | Standard Deviation 7.32 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Total B cells | 19.84 percentage of cells | Standard Deviation 10.33 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Total B cells | 20.70 percentage of cells | Standard Deviation 9.28 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Total B cells | 20.48 percentage of cells | Standard Deviation 8.92 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Total B cells | 22.05 percentage of cells | Standard Deviation 10.99 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Memory B cells (MBCs) | 7.47 percentage of cells | Standard Deviation 3.18 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Memory B cells (MBCs) | 7.34 percentage of cells | Standard Deviation 3.08 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Memory B cells (MBCs) | 7.63 percentage of cells | Standard Deviation 3.91 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Memory B cells (MBCs) | 7.44 percentage of cells | Standard Deviation 3.46 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Memory B cells (MBCs) | 7.17 percentage of cells | Standard Deviation 2.93 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Memory B cells (MBCs) | 7.53 percentage of cells | Standard Deviation 3.38 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Memory B cells (MBCs) | 7.66 percentage of cells | Standard Deviation 3.68 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Classical MBCs | 1.24 percentage of cells | Standard Deviation 0.78 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Classical MBCs | 0.96 percentage of cells | Standard Deviation 0.55 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Classical MBCs | 1.06 percentage of cells | Standard Deviation 0.69 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Classical MBCs | 1.15 percentage of cells | Standard Deviation 0.6 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Classical MBCs | 0.90 percentage of cells | Standard Deviation 0.48 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Classical MBCs | 0.91 percentage of cells | Standard Deviation 0.53 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Classical MBCs | 0.93 percentage of cells | Standard Deviation 0.57 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Activated MBCs | 6.28 percentage of cells | Standard Deviation 2.78 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Activated MBCs | 6.37 percentage of cells | Standard Deviation 2.79 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Activated MBCs | 6.59 percentage of cells | Standard Deviation 3.69 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Activated MBCs | 6.46 percentage of cells | Standard Deviation 3.15 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Activated MBCs | 6.25 percentage of cells | Standard Deviation 2.69 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Activated MBCs | 6.61 percentage of cells | Standard Deviation 3.09 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Activated MBCs | 6.71 percentage of cells | Standard Deviation 3.38 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Tissue-like MBCs | 1.27 percentage of cells | Standard Deviation 0.9 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Tissue-like MBCs | 1.01 percentage of cells | Standard Deviation 0.62 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Tissue-like MBCs | 1.09 percentage of cells | Standard Deviation 0.69 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Tissue-like MBCs | 1.04 percentage of cells | Standard Deviation 0.63 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Tissue-like MBCs | 0.96 percentage of cells | Standard Deviation 0.56 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Tissue-like MBCs | 0.95 percentage of cells | Standard Deviation 0.54 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Tissue-like MBCs | 0.99 percentage of cells | Standard Deviation 0.6 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Switched B cells | 1.58 percentage of cells | Standard Deviation 1.24 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Switched B cells | 1.23 percentage of cells | Standard Deviation 1.21 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Switched B cells | 1.39 percentage of cells | Standard Deviation 1.21 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Switched B cells | 1.33 percentage of cells | Standard Deviation 1.12 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Switched B cells | 1.17 percentage of cells | Standard Deviation 1.06 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Switched B cells | 1.35 percentage of cells | Standard Deviation 1.13 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Switched B cells | 1.75 percentage of cells | Standard Deviation 2.15 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Unswitched B cells | 7.96 percentage of cells | Standard Deviation 3.37 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Unswitched B cells | 7.76 percentage of cells | Standard Deviation 3.26 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Unswitched B cells | 8.16 percentage of cells | Standard Deviation 4.27 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Unswitched B cells | 7.90 percentage of cells | Standard Deviation 3.6 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Unswitched B cells | 7.58 percentage of cells | Standard Deviation 3.07 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Unswitched B cells | 7.98 percentage of cells | Standard Deviation 3.52 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Unswitched B cells | 8.11 percentage of cells | Standard Deviation 3.83 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Naïve B cells | 4.74 percentage of cells | Standard Deviation 2.61 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Naïve B cells | 5.13 percentage of cells | Standard Deviation 3 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Naïve B cells | 5.02 percentage of cells | Standard Deviation 3.02 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Naïve B cells | 4.85 percentage of cells | Standard Deviation 3.07 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Naïve B cells | 4.97 percentage of cells | Standard Deviation 3.1 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Naïve B cells | 5.28 percentage of cells | Standard Deviation 3.18 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Naïve B cells | 5.55 percentage of cells | Standard Deviation 3.41 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Plasmablasts | 5.38 percentage of cells | Standard Deviation 3.63 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Plasmablasts | 4.67 percentage of cells | Standard Deviation 3.79 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Plasmablasts | 4.85 percentage of cells | Standard Deviation 3.68 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Plasmablasts | 5.12 percentage of cells | Standard Deviation 3.89 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Plasmablasts | 4.66 percentage of cells | Standard Deviation 3.53 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Plasmablasts | 4.21 percentage of cells | Standard Deviation 3.08 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Plasmablasts | 4.33 percentage of cells | Standard Deviation 3.26 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Exhausted B cells | 3.13 percentage of cells | Standard Deviation 1.83 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Exhausted B cells | 2.36 percentage of cells | Standard Deviation 1.48 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Exhausted B cells | 2.68 percentage of cells | Standard Deviation 1.88 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Exhausted B cells | 2.71 percentage of cells | Standard Deviation 1.5 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Exhausted B cells | 2.25 percentage of cells | Standard Deviation 1.22 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Exhausted B cells | 2.45 percentage of cells | Standard Deviation 1.33 |
| Reduxium | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Exhausted B cells | 2.83 percentage of cells | Standard Deviation 2.31 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Th1 cells | 47.80 percentage of cells | Standard Deviation 33.09 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Th1 cells | 47.30 percentage of cells | Standard Deviation 30.82 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Th1 cells | 47.58 percentage of cells | Standard Deviation 32.12 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Th17 cells | 1.28 percentage of cells | Standard Deviation 0.8 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Th17 cells | 1.16 percentage of cells | Standard Deviation 0.91 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Th17 cells | 1.21 percentage of cells | Standard Deviation 0.99 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Th17 cells | 1.19 percentage of cells | Standard Deviation 1.07 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Th17 cells | 1.16 percentage of cells | Standard Deviation 1.16 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Th17 cells | 1.14 percentage of cells | Standard Deviation 0.84 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Th17 cells | 1.24 percentage of cells | Standard Deviation 1.22 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Th2 cells | 2.86 percentage of cells | Standard Deviation 1.75 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Total CD8+ T cells | 35.08 percentage of cells | Standard Deviation 9.19 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Total CD8+ T cells | 34.46 percentage of cells | Standard Deviation 9.34 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Total CD8+ T cells | 35.30 percentage of cells | Standard Deviation 8.88 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Total CD8+ T cells | 34.68 percentage of cells | Standard Deviation 9.93 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Total CD8+ T cells | 34.49 percentage of cells | Standard Deviation 9.56 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Exhausted CD8+ T cells | 1.81 percentage of cells | Standard Deviation 1.15 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Exhausted CD8+ T cells | 2.06 percentage of cells | Standard Deviation 1.42 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Exhausted CD8+ T cells | 2.03 percentage of cells | Standard Deviation 1.44 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Exhausted CD8+ T cells | 1.61 percentage of cells | Standard Deviation 1 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Exhausted CD8+ T cells | 1.78 percentage of cells | Standard Deviation 1.18 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Exhausted CD8+ T cells | 2.00 percentage of cells | Standard Deviation 1.36 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Exhausted CD8+ T cells | 1.88 percentage of cells | Standard Deviation 1.08 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Total CD4+ cells | 54.16 percentage of cells | Standard Deviation 10.98 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Total CD4+ cells | 53.57 percentage of cells | Standard Deviation 12.13 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Total CD4+ cells | 53.97 percentage of cells | Standard Deviation 11.34 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Total CD4+ cells | 53.34 percentage of cells | Standard Deviation 12.22 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Total CD4+ cells | 53.58 percentage of cells | Standard Deviation 10.85 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Total CD4+ cells | 54.79 percentage of cells | Standard Deviation 12.3 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Total CD4+ cells | 54.49 percentage of cells | Standard Deviation 12.54 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Exhausted CD4+ T cells | 11.30 percentage of cells | Standard Deviation 5.46 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 -Exhausted CD4+ T cells | 11.93 percentage of cells | Standard Deviation 5.39 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 -Exhausted CD4+ T cells | 11.15 percentage of cells | Standard Deviation 4.49 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 -Exhausted CD4+ T cells | 10.87 percentage of cells | Standard Deviation 5.96 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 -Exhausted CD4+ T cells | 10.65 percentage of cells | Standard Deviation 5.15 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 -Exhausted CD4+ T cells | 11.59 percentage of cells | Standard Deviation 5.76 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 -Exhausted CD4+ T cells | 11.27 percentage of cells | Standard Deviation 4.9 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline -Regulatory T cells (Tregs) | 6.32 percentage of cells | Standard Deviation 1.39 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Regulatory T cells (Tregs) | 6.95 percentage of cells | Standard Deviation 1.5 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Regulatory T cells (Tregs) | 7.34 percentage of cells | Standard Deviation 1.8 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Regulatory T cells (Tregs) | 6.49 percentage of cells | Standard Deviation 1.93 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Regulatory T cells (Tregs) | 6.88 percentage of cells | Standard Deviation 1.9 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Regulatory T cells (Tregs) | 6.81 percentage of cells | Standard Deviation 1.9 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Regulatory T cells (Tregs) | 7.05 percentage of cells | Standard Deviation 1.53 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - chemokine receptor 3 (CXCR3)-Chemokine receptor 6 (CCR6)+ | 1.02 percentage of cells | Standard Deviation 1.45 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - CXCR3-CCR6+ | 1.24 percentage of cells | Standard Deviation 2.24 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - CXCR3-CCR6+ | 1.09 percentage of cells | Standard Deviation 1.81 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - CXCR3-CCR6+ | 1.60 percentage of cells | Standard Deviation 2.23 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - CXCR3-CCR6+ | 1.34 percentage of cells | Standard Deviation 1.94 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - CXCR3-CCR6+ | 1.32 percentage of cells | Standard Deviation 1.92 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - CXCR3-CCR6+ | 1.09 percentage of cells | Standard Deviation 1.63 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - T helper (Th) 1/Th17 cells | 7.17 percentage of cells | Standard Deviation 5.19 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Th1/Th17 cells | 6.02 percentage of cells | Standard Deviation 5.48 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Th1/Th17 cells | 5.33 percentage of cells | Standard Deviation 5.12 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Th1/Th17 cells | 4.55 percentage of cells | Standard Deviation 3.92 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Th1/Th17 cells | 4.57 percentage of cells | Standard Deviation 3.67 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Th1/Th17 cells | 4.70 percentage of cells | Standard Deviation 3.69 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Th1/Th17 cells | 4.56 percentage of cells | Standard Deviation 3.8 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Th1 cells | 48.63 percentage of cells | Standard Deviation 24.93 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Th1 cells | 45.58 percentage of cells | Standard Deviation 30.23 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Th1 cells | 44.85 percentage of cells | Standard Deviation 31.63 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Th1 cells | 44.15 percentage of cells | Standard Deviation 31.98 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Th2 cells | 3.67 percentage of cells | Standard Deviation 2.28 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Th2 cells | 3.58 percentage of cells | Standard Deviation 2.13 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Th2 cells | 3.46 percentage of cells | Standard Deviation 1.97 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Th2 cells | 3.56 percentage of cells | Standard Deviation 1.94 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Th2 cells | 3.82 percentage of cells | Standard Deviation 2.33 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Th2 cells | 4.05 percentage of cells | Standard Deviation 2.23 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - T follicular helper cells (Tfh) | 13.75 percentage of cells | Standard Deviation 2.67 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - T follicular helper cells (Tfh) | 12.75 percentage of cells | Standard Deviation 3.52 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - T follicular helper cells (Tfh) | 12.02 percentage of cells | Standard Deviation 3.48 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - T follicular helper cells (Tfh) | 12.40 percentage of cells | Standard Deviation 3.83 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - T follicular helper cells (Tfh) | 12.22 percentage of cells | Standard Deviation 3.16 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - T follicular helper cells (Tfh) | 12.33 percentage of cells | Standard Deviation 3.5 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - T follicular helper cells (Tfh) | 11.58 percentage of cells | Standard Deviation 4.92 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Activated Tfh (Inducible T-cell Costimulator (ICOS+)) | 0.50 percentage of cells | Standard Deviation 0.24 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Activated Tfh (ICOS+) | 0.45 percentage of cells | Standard Deviation 0.24 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Activated Tfh (ICOS+) | 0.44 percentage of cells | Standard Deviation 0.27 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Activated Tfh (ICOS+) | 0.38 percentage of cells | Standard Deviation 0.22 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Activated Tfh (ICOS+) | 0.40 percentage of cells | Standard Deviation 0.23 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Activated Tfh (ICOS+) | 0.47 percentage of cells | Standard Deviation 0.26 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Activated Tfh (ICOS+) | 0.48 percentage of cells | Standard Deviation 0.32 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Activated Tfh (Programmed cell death protein 1 (PD-1+)) | 2.30 percentage of cells | Standard Deviation 0.84 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Activated Tfh (PD-1+) | 2.25 percentage of cells | Standard Deviation 0.88 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Activated Tfh (PD-1+) | 2.08 percentage of cells | Standard Deviation 1.01 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Activated Tfh (PD-1+) | 2.01 percentage of cells | Standard Deviation 0.85 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Activated Tfh (PD-1+) | 2.08 percentage of cells | Standard Deviation 0.85 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Activated Tfh (PD-1+) | 2.20 percentage of cells | Standard Deviation 0.91 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Activated Tfh (PD-1+) | 2.18 percentage of cells | Standard Deviation 1.16 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Activated Tfh (ICOS+PD-1+) | 1.18 percentage of cells | Standard Deviation 0.67 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Activated Tfh (ICOS+PD-1+) | 1.17 percentage of cells | Standard Deviation 0.58 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Activated Tfh (ICOS+PD-1+) | 1.18 percentage of cells | Standard Deviation 0.6 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Activated Tfh (ICOS+PD-1+) | 1.00 percentage of cells | Standard Deviation 0.49 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Activated Tfh (ICOS+PD-1+) | 1.08 percentage of cells | Standard Deviation 0.46 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Activated Tfh (ICOS+PD-1+) | 1.32 percentage of cells | Standard Deviation 0.89 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Activated Tfh (ICOS+PD-1+) | 1.33 percentage of cells | Standard Deviation 0.84 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Total T cells | 60.53 percentage of cells | Standard Deviation 9.24 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Total T cells | 60 percentage of cells | Standard Deviation 10.27 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 4 - Total T cells | 59.29 percentage of cells | Standard Deviation 9.44 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 5 - Total T cells | 56.52 percentage of cells | Standard Deviation 11.88 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 6 - Total T cells | 57.44 percentage of cells | Standard Deviation 12.75 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 7 - Total T cells | 58.54 percentage of cells | Standard Deviation 10.23 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 8 - Total T cells | 58.54 percentage of cells | Standard Deviation 11.09 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Baseline - Total CD8 (cluster of differentiation 8)+ T cells | 34.08 percentage of cells | Standard Deviation 8.98 |
| Reduxium | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Week 3 - Total CD8+ T cells | 35.08 percentage of cells | Standard Deviation 8.71 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 8 - Intermediate monocytes | 7.49 percentage of cells | Standard Deviation 7.31 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Baseline - Non-classical monocytes | 4.88 percentage of cells | Standard Deviation 3.41 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 3 - Non-classical monocytes | 2.50 percentage of cells | Standard Deviation 1.84 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 4 - Non-classical monocytes | 2.99 percentage of cells | Standard Deviation 2.01 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 5 - Non-classical monocytes | 2.94 percentage of cells | Standard Deviation 2.15 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 6 - Non-classical monocytes | 2.51 percentage of cells | Standard Deviation 2.04 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 7 - Non-classical monocytes | 2.73 percentage of cells | Standard Deviation 1.8 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 8 - Non-classical monocytes | 3.26 percentage of cells | Standard Deviation 1.68 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Baseline - Intermediate monocytes | 7.26 percentage of cells | Standard Deviation 7.17 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 3 - Intermediate monocytes | 4.00 percentage of cells | Standard Deviation 5.63 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 4 - Intermediate monocytes | 5.60 percentage of cells | Standard Deviation 5.6 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 5 - Intermediate monocytes | 5.79 percentage of cells | Standard Deviation 7.2 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 6 - Intermediate monocytes | 5.41 percentage of cells | Standard Deviation 6.23 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 7 - Intermediate monocytes | 6.08 percentage of cells | Standard Deviation 6.32 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Baseline - Classical monocytes | 78.92 percentage of cells | Standard Deviation 11.78 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 3 - Classical monocytes | 84.86 percentage of cells | Standard Deviation 8.92 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 4 - Classical monocytes | 83.27 percentage of cells | Standard Deviation 9.06 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 5 - Classical monocytes | 83.68 percentage of cells | Standard Deviation 10.25 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 6 - Classical monocytes | 85.39 percentage of cells | Standard Deviation 8.31 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 7 - Classical monocytes | 84.87 percentage of cells | Standard Deviation 8.45 |
| Reduxium | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Week 8 - Classical monocytes | 82.72 percentage of cells | Standard Deviation 10.86 |
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
Population: healthy participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Baseline - CD16+CD56++ | 0.94 percentage of cells | Standard Deviation 0.47 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 3 - CD16+CD56++ | 1.09 percentage of cells | Standard Deviation 0.68 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | CD16++CD56- - Baseline | 0.89 percentage of cells | Standard Deviation 0.62 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 3 - CD16++CD56- | 0.91 percentage of cells | Standard Deviation 0.5 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 4 - CD16++CD56- | 0.99 percentage of cells | Standard Deviation 0.44 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 5 - CD16++CD56- | 0.83 percentage of cells | Standard Deviation 0.39 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 6 - CD16++CD56- | 1.02 percentage of cells | Standard Deviation 0.58 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 7 - CD16++CD56- | 1.24 percentage of cells | Standard Deviation 0.6 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 8 - CD16++CD56- | 1.34 percentage of cells | Standard Deviation 0.56 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Baseline - CD16+CD56+ | 67.89 percentage of cells | Standard Deviation 13.2 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 3 - CD16+CD56+ | 66.63 percentage of cells | Standard Deviation 15.26 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 4 - CD16+CD56+ | 66.31 percentage of cells | Standard Deviation 15.48 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 5 - CD16+CD56+ | 67.07 percentage of cells | Standard Deviation 15.67 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 6 - CD16+CD56+ | 69.92 percentage of cells | Standard Deviation 13.13 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 7 - CD16+CD56+ | 69.86 percentage of cells | Standard Deviation 10.9 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 8 - CD16+CD56+ | 69.04 percentage of cells | Standard Deviation 13.01 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 4 - CD16+CD56++ | 0.96 percentage of cells | Standard Deviation 0.45 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 5 - CD16+CD56++ | 0.90 percentage of cells | Standard Deviation 0.42 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 6 - CD16+CD56++ | 1.08 percentage of cells | Standard Deviation 0.59 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 7 - CD16+CD56++ | 1.06 percentage of cells | Standard Deviation 0.45 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 8 - CD16+CD56++ | 1.23 percentage of cells | Standard Deviation 0.68 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Baseline - CD16-CD56+ | 2.05 percentage of cells | Standard Deviation 1.01 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 3 - CD16-CD56+ | 1.78 percentage of cells | Standard Deviation 0.98 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 4 - CD16-CD56+ | 1.68 percentage of cells | Standard Deviation 0.69 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 5 - CD16-CD56+ | 1.68 percentage of cells | Standard Deviation 0.84 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 6 - CD16-CD56+ | 1.61 percentage of cells | Standard Deviation 0.73 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 7 - CD16-CD56+ | 1.66 percentage of cells | Standard Deviation 0.73 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 8 - CD16-CD56+ | 1.56 percentage of cells | Standard Deviation 0.84 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Baseline - CD16-CD56++ | 2.98 percentage of cells | Standard Deviation 1.54 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 3 - CD16-CD56++ | 2.90 percentage of cells | Standard Deviation 1.6 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 4 - CD16-CD56++ | 2.66 percentage of cells | Standard Deviation 1.23 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 5 - CD16-CD56++ | 2.61 percentage of cells | Standard Deviation 1.26 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 6 - CD16-CD56++ | 2.84 percentage of cells | Standard Deviation 1.44 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 7 - CD16-CD56++ | 2.67 percentage of cells | Standard Deviation 1.06 |
| Reduxium | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Week 8 - CD16-CD56++ | 3.16 percentage of cells | Standard Deviation 1.79 |
Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
ALT blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake | Baseline | 15.90 U/L | Standard Deviation 7.66 |
| Reduxium | Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake | Week 8 | 17.40 U/L | Standard Deviation 9.45 |
Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Albumin blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Liver Panel (Albumin) After 2 Weeks of Reduxium Intake | Baseline | 42.80 g/L | Standard Deviation 3.37 |
| Reduxium | Liver Panel (Albumin) After 2 Weeks of Reduxium Intake | Week 8 | 42.95 g/L | Standard Deviation 2.03 |
Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
ALP blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake | Baseline | 62.90 U/L | Standard Deviation 19.82 |
| Reduxium | Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake | Week 8 | 59.90 U/L | Standard Deviation 15.87 |
Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
AST blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake | Baseline | 19.50 U/L | Standard Deviation 3.35 |
| Reduxium | Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake | Week 8 | 20.55 U/L | Standard Deviation 4.15 |
Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Bilirubin blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake | Week 8 | 11.25 umol/L | Standard Deviation 3.5 |
| Reduxium | Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake | Baseline | 11.90 umol/L | Standard Deviation 4.09 |
Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
LDH blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake | Baseline | 310.80 U/L | Standard Deviation 43.87 |
| Reduxium | Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake | Week 8 | 377 U/L | Standard Deviation 108.54 |
Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Creatinine blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake | Week 8 | 68.85 umol/L | Standard Deviation 11.76 |
| Reduxium | Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake | Baseline | 69.05 umol/L | Standard Deviation 12.09 |
Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Potassium blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Renal Panel (Potassium) After 2 Weeks of Reduxium Intake | Baseline | 4.26 mmol/L | Standard Deviation 0.49 |
| Reduxium | Renal Panel (Potassium) After 2 Weeks of Reduxium Intake | Week 8 | 4.54 mmol/L | Standard Deviation 0.46 |
Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Sodium blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Renal Panel (Sodium) After 2 Weeks of Reduxium Intake | Baseline | 139.55 mmol/L | Standard Deviation 1.43 |
| Reduxium | Renal Panel (Sodium) After 2 Weeks of Reduxium Intake | Week 8 | 139.40 mmol/L | Standard Deviation 1.59 |
Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Urea blood tests
Time frame: Baseline and week 8 post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduxium | Renal Panel (Urea) After 2 Weeks of Reduxium Intake | Baseline | 4.20 mmol/L | Standard Deviation 1.45 |
| Reduxium | Renal Panel (Urea) After 2 Weeks of Reduxium Intake | Week 8 | 4.04 mmol/L | Standard Deviation 1.08 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduxium | Number of Adverse Events After Reduxium Intake | 0 adverse events |