MedTrace Logo

Calorie Restriction in Multiple Sclerosis Patients

NCT02411838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-05-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Calorie restriction

Calorie restriction will be achieved by alternate day fasting. During the day of fasting the subject will be allowed to eat two salads with light dressing, not to go over approximately 500 calories. The CR group subjects will fast on day 2 (second day of steroids) and then continue to fast on alternate days until day 15. This is the end of the Acute CR phase of the Study, and patients may discontinue the study at this point. Chronic CR phase At the end of the Acute CR phase, both groups will be offered to enroll in the alternate day fasting regimen for 6 months (Chronic CR phase). During this phase, patients with a BMI \<28 will follow a regimen of fasting for two days per week while patients with BMI\>28 will follow a regimen of fasting for three days per week.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Laura Piccio, MD, PhD · Washington University School of Medicine

  • Anne H Cross, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411838 on ClinicalTrials.gov