NCT04525456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

June 29, 2020

Results QC Date

February 28, 2022

Last Update Submit

May 26, 2022

Conditions

Immune ToleranceViral Infection

Keywords

AntibodyImmunophenotypingImmune cells

Outcome Measures

Primary Outcomes (14)

  • 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

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

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

    Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies

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

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

    Blood tests of monocytes subsets utilising groups of labelled antibodies

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

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

    Blood tests of NK cell subsets utilising groups of labelled antibodies

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

  • Renal Panel (Sodium) After 2 Weeks of Reduxium Intake

    Sodium blood tests

    Baseline and week 8 post-baseline

  • Renal Panel (Potassium) After 2 Weeks of Reduxium Intake

    Potassium blood tests

    Baseline and week 8 post-baseline

  • Renal Panel (Urea) After 2 Weeks of Reduxium Intake

    Urea blood tests

    Baseline and week 8 post-baseline

  • Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake

    Creatinine blood tests

    Baseline and week 8 post-baseline

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

    AST blood tests

    Baseline and week 8 post-baseline

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

    ALT blood tests

    Baseline and week 8 post-baseline

  • Liver Panel (Albumin) After 2 Weeks of Reduxium Intake

    Albumin blood tests

    Baseline and week 8 post-baseline

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

    ALP blood tests

    Baseline and week 8 post-baseline

  • Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake

    Bilirubin blood tests

    Baseline and week 8 post-baseline

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

    LDH blood tests

    Baseline and week 8 post-baseline

Secondary Outcomes (1)

  • Number of Adverse Events After Reduxium Intake

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

Study Arms (1)

Reduxium

EXPERIMENTAL

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

Dietary Supplement: Reduxium

Interventions

ReduxiumDIETARY_SUPPLEMENT

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

Reduxium

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National University of Singapore - The N.1 Institute for Health

Singapore, 117456, Singapore

Location

National University of Singapore - Yong Loo Lin School of Medicine

Singapore, 117597, Singapore

Location

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (4)

  • Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. doi: 10.1093/ajcn/66.2.460S.

    PMID: 9250133BACKGROUND

  • Wintergerst ES, Maggini S, Hornig DH. Contribution of selected vitamins and trace elements to immune function. Ann Nutr Metab. 2007;51(4):301-23. doi: 10.1159/000107673. Epub 2007 Aug 28.

    PMID: 17726308BACKGROUND

  • Cui W, Fan Y, Wu W, Zhang F, Wang JY, Ni AP. Expression of lymphocytes and lymphocyte subsets in patients with severe acute respiratory syndrome. Clin Infect Dis. 2003 Sep 15;37(6):857-9. doi: 10.1086/378587. Epub 2003 Aug 28.

    PMID: 12955652BACKGROUND

  • Li T, Qiu Z, Zhang L, Han Y, He W, Liu Z, Ma X, Fan H, Lu W, Xie J, Wang H, Deng G, Wang A. Significant changes of peripheral T lymphocyte subsets in patients with severe acute respiratory syndrome. J Infect Dis. 2004 Feb 15;189(4):648-51. doi: 10.1086/381535. Epub 2004 Feb 4.

    PMID: 14767818BACKGROUND

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

Title
Study administrator
Organization
NUS
lsixtc@nus.edu.sg
+65 6601 7766

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-centre, one-arm, prospective study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

August 25, 2020

Study Start

October 7, 2020

Primary Completion

December 15, 2020

Study Completion

January 27, 2021

Last Updated

May 27, 2022

Results First Posted

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available

Locations

SG(3)