Immune Responses With Reduxium

Sponsor
Ogevity Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04525456
Collaborator
National University, Singapore (Other)
20
3
1
3.7
6.7
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Reduxium
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
single-centre, one-arm, prospective studysingle-centre, one-arm, prospective study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Changes in the Immune Responses With Reduxium in Healthy Adults
Actual Study Start Date :
Oct 7, 2020
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Jan 27, 2021

Arms and Interventions

Arm Intervention/Treatment
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
Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. Renal Panel (Sodium) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    Sodium blood tests

  6. Renal Panel (Potassium) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    Potassium blood tests

  7. Renal Panel (Urea) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    Urea blood tests

  8. Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    Creatinine blood tests

  9. Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    AST blood tests

  10. Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    ALT blood tests

  11. Liver Panel (Albumin) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    Albumin blood tests

  12. Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    ALP blood tests

  13. Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    Bilirubin blood tests

  14. Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake [Baseline and week 8 post-baseline]

    LDH blood tests

Secondary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 50 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University of Singapore - The N.1 Institute for Health Singapore Singapore 117456
2 National University of Singapore - Yong Loo Lin School of Medicine Singapore Singapore 117597
3 National University Hospital Singapore Singapore 119074

Sponsors and Collaborators

  • Ogevity Therapeutics, Inc.
  • National University, Singapore

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Ogevity Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04525456
Other Study ID Numbers:
  • 0101.2006.0101.0001
First Posted:
Aug 25, 2020
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ogevity Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Recruitment happened between October 7, 2020 and January 27, 2021 at National University Hospital (NUH) in Singapore.
Pre-assignment Detail
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Period Title: Overall Study
STARTED 20
COMPLETED 20
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Reduxium
Arm/Group Description 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.
Overall Participants 20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
32.4
(5.4)
Sex: Female, Male (Count of Participants)
Female
14
70%
Male
6
30%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
Singapore
20
100%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 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.
Measure Participants 20
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)
2. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
healthy participants
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
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)
3. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
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)
4. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
healthy participants.
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
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)
5. Primary Outcome
Title Renal Panel (Sodium) After 2 Weeks of Reduxium Intake
Description Sodium blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
139.55
(1.43)
Week 8
139.40
(1.59)
6. Primary Outcome
Title Renal Panel (Potassium) After 2 Weeks of Reduxium Intake
Description Potassium blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
4.26
(0.49)
Week 8
4.54
(0.46)
7. Primary Outcome
Title Renal Panel (Urea) After 2 Weeks of Reduxium Intake
Description Urea blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
4.20
(1.45)
Week 8
4.04
(1.08)
8. Primary Outcome
Title Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake
Description Creatinine blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
69.05
(12.09)
Week 8
68.85
(11.76)
9. Primary Outcome
Title Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake
Description AST blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
19.50
(3.35)
Week 8
20.55
(4.15)
10. Primary Outcome
Title Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake
Description ALT blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
15.90
(7.66)
Week 8
17.40
(9.45)
11. Primary Outcome
Title Liver Panel (Albumin) After 2 Weeks of Reduxium Intake
Description Albumin blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
42.80
(3.37)
Week 8
42.95
(2.03)
12. Primary Outcome
Title Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake
Description ALP blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
62.90
(19.82)
Week 8
59.90
(15.87)
13. Primary Outcome
Title Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake
Description Bilirubin blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
11.90
(4.09)
Week 8
11.25
(3.50)
14. Primary Outcome
Title Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake
Description LDH blood tests
Time Frame Baseline and week 8 post-baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Baseline
310.80
(43.87)
Week 8
377
(108.54)
15. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
Measure Participants 20
Number [adverse events]
0

Adverse Events

Time Frame 8 weeks
Adverse Event Reporting Description
Arm/Group Title Reduxium
Arm/Group Description 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
All Cause Mortality
Reduxium
Affected / at Risk (%) # Events
Total 0/20 (0%)
Serious Adverse Events
Reduxium
Affected / at Risk (%) # Events
Total 0/20 (0%)
Other (Not Including Serious) Adverse Events
Reduxium
Affected / at Risk (%) # Events
Total 0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Study administrator
Organization NUS
Phone +65 6601 7766
Email lsixtc@nus.edu.sg
Responsible Party:
Ogevity Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04525456
Other Study ID Numbers:
  • 0101.2006.0101.0001
First Posted:
Aug 25, 2020
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022