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临床试验/NCT04525456
NCT04525456已完成不适用

Changes in the Immune Responses With Reduxium in Healthy Adults

Ogevity Therapeutics, Inc.6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
6
主要终点
Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake

时间窗: Baseline and week 8 post-baseline

Creatinine blood tests

Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake

时间窗: Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline

Blood tests of monocytes subsets utilising groups of labelled antibodies

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

时间窗: 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

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

时间窗: Baseline and week 8 post-baseline

ALT blood tests

Liver Panel (Albumin) After 2 Weeks of Reduxium Intake

时间窗: Baseline and week 8 post-baseline

Albumin blood tests

Renal Panel (Sodium) After 2 Weeks of Reduxium Intake

时间窗: Baseline and week 8 post-baseline

Sodium blood tests

Renal Panel (Potassium) After 2 Weeks of Reduxium Intake

时间窗: Baseline and week 8 post-baseline

Potassium blood tests

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

时间窗: Baseline and week 8 post-baseline

AST blood tests

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

时间窗: Baseline and week 8 post-baseline

ALP blood tests

Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake

时间窗: 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 (Urea) After 2 Weeks of Reduxium Intake

时间窗: Baseline and week 8 post-baseline

Urea blood tests

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

时间窗: Baseline and week 8 post-baseline

LDH blood tests

Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake

时间窗: Baseline and week 8 post-baseline

Bilirubin blood tests

次要结局

  • Number of Adverse Events After Reduxium Intake(Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline)

研究者

发起方
Ogevity Therapeutics, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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