Calorie Restriction in Multiple Sclerosis Patients
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|ClinicalTrials.gov Identifier: NCT02411838|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 29, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: Calorie restriction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis Patients|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||June 2017|
No Intervention: Control group
Steroid treatment (10 total days), which is a standard therapy for significant MS relapses.
Experimental: Calorie restriction
The intervention in this group will be to undergo a regimen of calorie restriction through fasting every other day (named "alternate day fasting").
Specifically this group will undergo alternate day fasting plus the same steroid regimen as the control group (CR GROUP).
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 IVMP) 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.
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.
- 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
- Clinical - Disability on the Expanded Disability Status Scale (EDSS) [ Time Frame: Two weeks, 3 and 6 months ]Specifically we will assess at the different time points changes in the Standardized neurologic exam called EDSS which assess clinically disability in patients with MS.
- Clinical-Ambulation, hand and cognitive functions on the Multiple Sclerosis Functional Composite (MSFC) scale [ Time Frame: Two weeks, 3 and 6 months ]The MSFC is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. (Cutter et al, 1999).
- Clinical - Cognitive functions using the Symbol Digit Modality Test (SDMT). [ Time Frame: Two weeks, 3 and 6 months ]The SDMT is a simple test to assess cognitive functions over time and assess response to treatment.
- Clinical - Quality of life on the Multiple Sclerosis Quality of Life Inventory (MSQLI). [ Time Frame: Two weeks, 3 and 6 months ]The MSQLI is a questionnaire to assess quality of life in MS patients.
- Gut microbiome changes ( stool sample ) [ Time Frame: Two weeks, 3 and 6 months ]A stool sample will be collected to assess the effect of the diet on the gut microbiome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411838
|United States, Missouri|
|Washington University in St Louis|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Laura Piccio, MD, PhD||Washington University School of Medicine|
|Principal Investigator:||Anne H Cross, MD||Washington University School of Medicine|