NCT02411838

A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis Patients

Completed NA Last updated 27 May 2020

What this trial tests

NA trial testing Calorie restriction in Multiple Sclerosis in 17 participants. Completed in 1 June 2017.

Timeline

1 February 2014

Primary endpoint
1 December 2016

1 June 2017

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	17
Start date	1 February 2014
Primary completion	1 December 2016
Estimated completion	1 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Calorie restriction

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 60, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Blood biomarkers
  Time frame: After two weeks, 3 and 6 months
  Serum levels of: adipokines (leptin, adiponectin and resistin)
• Blood biomarkers
  Time frame: After two weeks, 3 and 6 months
  Pro-inflammatory cytokines (IL-6, TNFalpha),
• Blood biomarker
  Time frame: After two weeks, 3 and 6 months
  cortisol
• Blood biomarker
  Time frame: After two weeks, 3 and 6 months
  T regulatory cell number and in vitro function

Sponsor's own description

The investigators hypothesize that adipokine (soluble molecules produced by the adipose tissue) levels are altered in MS compared to control subjects. Additionally, the investigators hypothesize that calorie restriction (CR) will improve clinical recovery from an MS relapse, ameliorate the adipokine and metabolic-inflammatory profile in MS, and enhance immune-regulatory mechanisms.

This is a pilot study to determine the effects of CR in MS patients during an acute MS relapse (Acute CR phase) and for 6 months afterwards (Chronic CR phase). Calorie restriction will be achieved by following a regimen of alternate day fasting. The investigators will evaluate clinical outcomes and blood biomarkers at different time points.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intermittent Fasting Confers Protection in CNS Autoimmunity by Altering the Gut Microbiota.
   Cignarella F, Cantoni C, Ghezzi L, Salter A, et al · · 2018 · cited 431× · PMID 29874567 · DOI 10.1016/j.cmet.2018.05.006
2. The Gut Microbiota in Multiple Sclerosis: An Overview of Clinical Trials.
   Schepici G, Silvestro S, Bramanti P, Mazzon E. · · 2019 · cited 123× · PMID 31512505 · DOI 10.1177/0963689719873890
3. Dietary regulation in health and disease.
   Wu Q, Gao ZJ, Yu X, Wang P. · · 2022 · cited 98× · PMID 35871218 · DOI 10.1038/s41392-022-01104-w
4. Wellness and the Role of Comorbidities in Multiple Sclerosis.
   Moss BP, Rensel MR, Hersh CM. · · 2017 · cited 46× · PMID 28785958 · DOI 10.1007/s13311-017-0563-6
5. Leptin and Leptin Signaling in Multiple Sclerosis: A Narrative Review.
   Flores-Cordero JA, Aranaz-Murillo A, Vilariño-García T, Pérez-Pérez A, et al · · 2025 · cited 4× · PMID 40019662 · DOI 10.1007/s12017-025-08842-4