Effects of anti-Inflammatory-antioxidant-rich diet and co-supplemented synbiotics intervention in patients with progressive forms of multiple sclerosis: a single-center, single-blind randomized clinical trial

ABSTRACT

Background

Current evidence has demonstrated that patients with Multiple Sclerosis (MS) have dysbiotic gut microbiomes, and anti-inflammatory nutritional interventions can normalize this status. Therefore, we aimed to investigate the effects of dietary intervention in patients with progressive forms of MS.

Methods

Seventy patients with three forms of progressive MS (primary-progressive, secondary-progressive, and progressive-relapsing) were randomly assigned into intervention (daily synbiotics capsule plus anti-inflammatory-antioxidant rich diet) or control (placebo capsule plus dietary recommendations) groups for four months. Faecal calprotectin level, Impact of Vision Impairment (IVI), Gastrointestinal Symptom Rating Scale (GSRS), and anthropometric measurements were evaluated at baseline and trial cessation. Analysis of covariance was conducted and adjusted for age, gender, education level, family history & duration of MS, type of progressive MS, type of main drug, and physical activity.

Results

Sixty-nine participants were included in the final analysis (n of intervention = 34; n of control = 35). Synbiotics and dietary intervention significantly reduced Faecal calprotectin level after six months (110.5 ± 75.9–44.7 ± 49.3 ɥg/g, P < 0.001), and mean changes were statistically significant in comparison with control group. However, intervention did not elicit any change in the anthropometric measurements.

Conclusion

Synbiotics supplementation and adherence to an anti-inflammatory-antioxidant-rich diet reduced intestinal inflammation and improved clinical manifestations in progressive forms of MS.

Trial registration: Iranian Registry of Clinical Trials identifier: IRCT20141108019853N7..

KEYWORDS:

• Synbiotics
• Probiotics
• anti-Inflammatory agents
• antioxidants
• diet therapy
• faecal calprotectin
• progressive multiple sclerosis
• randomized controlled trial

Acknowledgements

This study was extracted from Ph.D. dissertation which was approved by School of Nutrition & Food Science, Isfahan University of Medical Sciences (code: IR.MUI.RESEARCH.REC.1400.195). The trial was also registered at the Iranian Registry of Clinical Trials (WHO-approved; n. IRCT20141108019853N7). The authors thank all the participants of the study for their enthusiastic of involvement and to the personnel of the clinic. Amir Reza Moravejolahkami: Conceptualization, Investigation, Writing – Original Draft, Formal analysis, Data Curation, Resources, Methodology, Software, Writing – Review & Editing. Ahmad Chitsaz: Project administration, Visualization, Validation, Supervision. Akbar Hassanzadeh: Software, Supervision. Zamzam Paknahad: Supervision, Funding acquisition, Writing – Review & Editing

Ethics approval

The study was approved by the Ethics committee of Isfahan University of Medical Sciences, Isfahan, Iran. (IR.MUI.RESEARCH.REC.1400.195).

Human and animal rights

No animals were involved in the study. All human procedures were followed in accordance with the Helsinki Declaration of 1975 as revised in 2013 (http://ethics.iit.edu/ecodes/node/3931).

Consent for publication

A written informed consent was obtained from the participants prior to the publication of this study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The datasets used and/or analyzed during the current study are available from the corresponding author, [Prof. Zamzam Paknahad; [email protected]], on reasonable request.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.

Notes on contributors

Amir Reza Moravejolahkami

Amir Reza Moravejolahkami is a Ph.D. of Nutrition (clinical dietitian, academic researcher), with a B.Sc. of anesthesiology with first class honours (at Isfahan University of Medical Sciences, Isfahan, Iran). This young researcher works on a Multiple Sclerosis clinic (M.S Isfahan Center) and likes to investigate the effects of dietary interventions on chronic auto-inflammatory disorders like multiple sclerosis. He is A BIG FAN OF SYNBIOTICS, PROBIOTICS, PREBIOTICS, and POSTBIOTICS.

Ahmad Chitsaz

Ahmad Chitsaz is a Professor of Neurology at Department of Neurology, Isfahan University of Medical Sciences, Isfahan, Iran.

Akbar Hassanzadeh

Akbar Hassanzadeh is a M. Sc. of Biostatistics at Department of Epidemiology and Biostatistics, Faculty of Health, Isfahan University of Medical Sciences, Isfahan, Iran.

Zamzam Paknahad

Zamzam Paknahad is a Professor of Nutrition at Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.