N/A
N=20
Immune Responses With Reduxium
Immune Tolerance · Viral Infection
Bottom Line
View on ClinicalTrials.gov: NCT04525456 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake — 60.53; 60; 59.29; 56.52 percentage of cells
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reduxium (Dietary_supplement)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ogevity Therapeutics, Inc.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake |
60.53; 60; 59.29; 56.52; 57.44; 58.54 | — |
| PRIMARY Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake |
17.44; 21.09; 18.64; 19.84; 20.70; 20.48 | — |
| PRIMARY Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake |
4.88; 2.50; 2.99; 2.94; 2.51; 2.73 | — |
| PRIMARY Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake |
0.89; 0.91; 0.99; 0.83; 1.02; 1.24 | — |
| PRIMARY Renal Panel (Sodium) After 2 Weeks of Reduxium Intake |
139.55; 139.40 | — |
| PRIMARY Renal Panel (Potassium) After 2 Weeks of Reduxium Intake |
4.26; 4.54 | — |
| PRIMARY Renal Panel (Urea) After 2 Weeks of Reduxium Intake |
4.20; 4.04 | — |
| PRIMARY Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake |
69.05; 68.85 | — |
| PRIMARY Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake |
19.50; 20.55 | — |
| PRIMARY Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake |
15.90; 17.40 | — |
| PRIMARY Liver Panel (Albumin) After 2 Weeks of Reduxium Intake |
42.80; 42.95 | — |
| PRIMARY Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake |
62.90; 59.90 | — |
| PRIMARY Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake |
11.90; 11.25 | — |
| PRIMARY Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake |
310.80; 377 | — |
| SECONDARY Number of Adverse Events After Reduxium Intake |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects of 21 - 50 years of age
- Normal blood pressure (BP <140/90 nnHg)
- Normal fasting glucose (<6mmol/L)
- Subjects must stop all supplement for 1 month prior to enrolment
Exclusion Criteria
- Subjects with known history of lungs or cardiovascular disease
- History of previous pancreatitis
- Past or current history of malignancy
- Subjects with type 2 diabetes
- Past or current history of peptic ulcer disease
- Current pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT04525456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.