Calorie restriction for Multiple Sclerosis, Acute Relapsing

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple Sclerosis, Acute Relapsing+5 More
Calorie restriction - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether two different diets can help improve symptoms in people with MS.

Eligible Conditions
  • Multiple Sclerosis, Acute Relapsing
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Sclerosis, Acute Relapsing

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 34 Weeks

34 Weeks
Anthropometric Measures: Waist circumference
Anthropometric Measures: Weight
Blood Pressure
Blood work: IL-17
Blood work: IL-6
Blood work: NFL
Blood work: T17
Blood work: TNF-a
Blood work: adiponectin
Blood work: glucose
Blood work: insulin
Blood work: leptin
Blood work: lipids
Detailed body composition
Neuroinflammation
Patient reported outcomes: Fatigue Severity Scale (FSS)
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Total Body Composition
34 weeks
Anthropometric Measures: Height
Brief International Cognitive Assessment for MS (BICAMS)
Multiple Sclerosis

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Sclerosis, Acute Relapsing

Trial Design

2 Treatment Groups

Standard Glycemic Load
1 of 2
Low Glycemic Load
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Calorie restriction · No Placebo Group · N/A

Low Glycemic LoadExperimental Group · 3 Interventions: Glycemic load, Calorie restriction, Behavioral support · Intervention Types: Behavioral, Behavioral, Behavioral
Standard Glycemic LoadActiveComparator Group · 3 Interventions: Glycemic load, Calorie restriction, Behavioral support · Intervention Types: Behavioral, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calorie restriction
2014
N/A
~210
Behavioral support
2019
Completed Phase 4
~1340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 34 weeks

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,789 Previous Clinical Trials
2,271,776 Total Patients Enrolled
United States Department of DefenseFED
767 Previous Clinical Trials
202,141 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,419 Previous Clinical Trials
2,217,565 Total Patients Enrolled
Brooks Wingo, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are overweight or obese.
You are able to walk 100m without assistance.\n
You have not taken DMT in the past 6 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.