The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients

September 13, 2018 updated by: Tabriz University of Medical Sciences

The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Multiple Sclerosis Patients

Multiple sclerosis is the most common autoimmune disease of the central nervous system, most ranging in age from 40-20 years of age is associated with neurons inflammation and demyelination. Increasing aggressive activities of Th17 and Th1 cells that their function is to secrete proinflammatory cytokines and decreasing the number and activity of regulatory T cells, which normally leads to controlling inflammation, are seen in these patients.Many studies have carried out to assess the prevalence of Tregs and Th17 in autoimmune disorders such as MS. The Treg /Th17 functional balance is necessary for the impediment of autoimmune and inflammatory diseases by preventing harmful injury to the host and increasing effective immune responses. miRNAs have been shown to play a pivotal role in the pathogenesis of various diseases including autoimmune or auto-inflammatory diseases. Curcumin, the active principle constituent of turmeric, is proved to be capable of regulating cellular responses and the growth of different cell types in the immune system such as B cells, T cells, macrophages, dendritic cells and natural killer cells. Curcumin has a combination of activities such as anti-inflammatory, antioxidant, anti-proliferation, anti-invasive, and can used in the treatment of Alzheimer's, Parkinson's, Multiple sclerosis, Cardiovascular disease, Bacterial diseases and Arthritis. The solubility of curcumin in nanomicelles spherical water increases to more than 100 thousand times, which significantly enhances the absorption of curcumin. The present study aimed at investigating the effects of nanocurcumin on the frequency of Treg and Th17 cells, expression levels of their associated transcription factors and cytokines, secretion levels of their associated cytokines and also related miRNAs expression levels in peripheral blood of patients with MS.

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Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, fresh blood samples were acquired from 50 MS patients introduced by corresponding physician and Neurologist. As the aim of the current study was the assessment of nanocurcumin in MS patients, the peripheral blood collection was collected in two steps. After the first blood collection via venipuncture, 25 patients received nanocurcumin capsules each day and the remaining 25 patients took placebo for 6 months. Accordingly, the second sampling from the mentioned population was collected after 6 months. 9 patients were excluded from the study: 3 did not provide informed consent, 5 lived quite far away from the place in which follow-up examinations were performed, and 1 patient developed cancer. In all cases, 15 ml of blood was utilized for peripheral blood mononuclear cells (PBMC) isolation. PBMC is used to measure the expression levels of miRNA-106b, miRNA-25 and miRNA-326. In this regard, specific kits extracted miRNA from cells is used. Then the version of miRNA using Quantitative Real time polymerase chain reaction(qPCR).Then the frequency of Treg and Th17 cells in peripheral blood of patients will be examined by Flowcytometry and compared to the control group. The expression of key transcription factor (Foxp3) and specific cytokines (TGF-β) related to the Treg cells and key transcription factor (RORγt) and specific cytokines, interleukin-17(IL-17), related to the Th17 are measured by Quantitative Real time PCR. Elisa methos is used to assess the amount of the cytokine TGF-β and IL-17 in cultured cells.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willingness to cooperate
  • Aged 18 to 65 years
  • The diagnosis of Multiple sclerosis by Neurologist
  • Patients in Relapsing Remitting (RRMS)
  • Patients with Expanded Disability Status Scale (EDSS) <5/5.

Exclusion Criteria:

  • Use of nutritional supplements and antioxidant and immunosuppressive drugs alpha-lipoic acid a month before the study.
  • Pregnancy and lactation
  • History of diabetes and other chronic diseases
  • History of other autoimmune diseases
  • Occurrence of relapses during the study period
  • Acceptance rate of less than 70% of supplements
  • Unwillingness to continue to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients who received nanocurcumin
Drug: Nanocurcumin
Patients will take 80 mg nanocurcumin in the form of capsules daily during the 6 month study period
Other Names:
  • Patients who received nanocurcumin
Placebo Comparator: Patients who received placebo
Drug: Placebo
Patients will take placebo in the form of capsules daily during 6 months study period
Other Names:
  • Patients who received placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDSS measurment
Time Frame: 6 months after treatment
EDSS measurment by neurologist
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treg cells frequency
Time Frame: 6 months after treatment
Flowcytometry (Treg cells produce anti-inflammatory cytokines)
6 months after treatment
Th17 cells frequency
Time Frame: 6 months after treatment
Flowcytometry (Th17 cells produce inflammatory cytokine and increase inflammation)
6 months after treatment
IL-17 and RORγt expression
Time Frame: 6 months after treatment
qPCR method
6 months after treatment
IL-17 secretion levels
Time Frame: 6 months after treatment
ELISA method
6 months after treatment
microRNAs (miRNA-326) expression
Time Frame: 6 months after treatment
Evaluate the diagnostic value of microRNAs in quantitative polymerase chain reaction (qPCR), in MS patients as compared with healthy control
6 months after treatment
TGF-β and FoxP3 expression
Time Frame: 6 months after treatment
qPCR method
6 months after treatment
TGF-β secretion levels
Time Frame: 6 months after treatment
ELISA method
6 months after treatment
microRNAs (miRNA-106b and miRNA-25) expression
Time Frame: 6 months after treatment
Evaluate the diagnostic value of microRNAs in quantitative polymerase chain reaction
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabriz University of Medical Sciences

Investigators

  • Study Director: Mehdi Yousefi, Ph.D, Tabriz University of Medical Scienses
  • Study Chair: Hormoz Ayromlou, Neurologist, Tabriz University of Medical Scienses

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2016

Primary Completion (Actual)

August 10, 2017

Study Completion (Actual)

November 7, 2017

Study Registration Dates

First Submitted

May 6, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TabrizUMS-Nerve-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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