Calorie Restriction in Multiple Sclerosis Patients
Completed · Not applicable
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02411838
- Run by
- Washington University School of Medicine
- People needed
- 17
- Starts
- 2014-02-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2020-05-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must be diagnosed with relapsing MS.
- Participants must be 18 - 60 years old.
- Participants will need to be experiencing a relapse as identified by their neurologist.
- Participants must have body mass index (BMI) of 23 or higher.
- Participants must not have other ongoing diseases in other systems.
You may not qualify if…
- History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
- Use of insulin pumps or insulin injections for diabetes.
- Use of drugs like Warfarin or Coumadin that need to monitor the intake of vegetables containing high levels of vitamin K.
- Patients that are required by a physician to follow a special diet or food restriction (diabetic, gastric bypass, soft/pureed food, etc.)
- Alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.
Where it is running
- Washington University in St Louis — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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