Calorie Restriction in Multiple Sclerosis Patients
A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis Patients
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Calorie restriction
What it measured
Main measures
Blood biomarkers
After two weeks, 3 and 6 months
Blood or spinal fluid markersImmune responseBlood biomarker
After two weeks, 3 and 6 months
Blood or spinal fluid markers
Other measures (5)
Clinical - Disability on the Expanded Disability Status Scale (EDSS)
Two weeks, 3 and 6 months
Disability progressionClinical-Ambulation, hand and cognitive functions on the Multiple Sclerosis Functional Composite (MSFC) scale
Two weeks, 3 and 6 months
Disability progressionThinking and memoryClinical - Cognitive functions using the Symbol Digit Modality Test (SDMT).
Two weeks, 3 and 6 months
Thinking and memoryClinical - Quality of life on the Multiple Sclerosis Quality of Life Inventory (MSQLI).
Two weeks, 3 and 6 months
Quality of life (reported by participants)Gut microbiome changes ( stool sample )
Two weeks, 3 and 6 months
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* 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.
Exclusion criteria
* 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Intermittent Fasting Confers Protection in CNS Autoimmunity by Altering the Gut Microbiota.Cell Metab · 2018
Results
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.Background
Piccio L, Cantoni C, Henderson JG, Hawiger D, Ramsbottom M, Mikesell R, Ryu J, Hsieh CS, Cremasco V, Haynes W, Dong LQ, Chan L, Galimberti D, Cross AH. Lack of adiponectin leads to increased lymphocyte activation and increased disease severity in a mouse model of multiple sclerosis. Eur J Immunol. 2013 Aug;43(8):2089-100. doi: 10.1002/eji.201242836. Epub 2013 Jun 7.Background
Piccio L, Stark JL, Cross AH. Chronic calorie restriction attenuates experimental autoimmune encephalomyelitis. J Leukoc Biol. 2008 Oct;84(4):940-8. doi: 10.1189/jlb.0208133. Epub 2008 Aug 4.
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History
Started
Feb 2014
Main results due
Dec 2016
Finished
Jun 2017