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The Immunomodulatory Effects of Oral Nanocurcumin in Multiple Sclerosis Patients

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03150966
Enrollment
41
Registered
2017-05-12
Start date
2016-06-08
Completion date
2017-11-07
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Nanocurcumin, MicroRNAs, Th17 cells, Treg cells

Brief summary

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. .

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.

Interventions

Patients will take 80 mg nanocurcumin in the form of capsules daily during the 6 month study period

DRUGPlacebo

Patients will take placebo in the form of capsules daily during 6 months study period

Sponsors

Tabriz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
EDSS measurment6 months after treatmentEDSS measurment by neurologist

Secondary

MeasureTime frameDescription
Th17 cells frequency6 months after treatmentFlowcytometry (Th17 cells produce inflammatory cytokine and increase inflammation)
IL-17 and RORγt expression6 months after treatmentqPCR method
IL-17 secretion levels6 months after treatmentELISA method
Treg cells frequency6 months after treatmentFlowcytometry (Treg cells produce anti-inflammatory cytokines)
TGF-β and FoxP3 expression6 months after treatmentqPCR method
TGF-β secretion levels6 months after treatmentELISA method
microRNAs (miRNA-106b and miRNA-25) expression6 months after treatmentEvaluate the diagnostic value of microRNAs in quantitative polymerase chain reaction
microRNAs (miRNA-326) expression6 months after treatmentEvaluate the diagnostic value of microRNAs in quantitative polymerase chain reaction (qPCR), in MS patients as compared with healthy control

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026