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Calorie Restriction in Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT02411838
Recruitment Status : Unknown
Verified April 2016 by Laura Piccio, Washington University School of Medicine.
Recruitment status was:  Recruiting
First Posted : April 8, 2015
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Laura Piccio, Washington University School of Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Calorie restriction Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
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
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Blood biomarkers [ Time Frame: After two weeks, 3 and 6 months ]
    Serum levels of: adipokines (leptin, adiponectin and resistin)

  2. Blood biomarkers [ Time Frame: After two weeks, 3 and 6 months ]
    Pro-inflammatory cytokines (IL-6, TNFalpha),

  3. Blood biomarker [ Time Frame: After two weeks, 3 and 6 months ]
    cortisol

  4. Blood biomarker [ Time Frame: After two weeks, 3 and 6 months ]
    T regulatory cell number and in vitro function


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Contact: Laura Piccio, MD, PhD 314-747-4591 picciol@neuro.wustl.edu
Contact: Anne H Cross, MD 314-747-0405 crossa@neuro.wustl.edu

Locations
United States, Missouri
Washington University in St Louis Recruiting
St Louis, Missouri, United States, 63110
Contact: Laura Piccio, MD, PhD    314-747-4591    picciol@neuro.wustl.edu   
Contact: Laura Piccio, MD, PhD    314-747-0405    crossa@neuro.wustl.edu   
Principal Investigator: Laura Piccio, MD, PhD         
Principal Investigator: Anne H Cross, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Laura Piccio, MD, PhD Washington University School of Medicine
Principal Investigator: Anne H Cross, MD Washington University School of Medicine

Publications:
Responsible Party: Laura Piccio, Research Assistamt Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02411838     History of Changes
Other Study ID Numbers: 201307106
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Laura Piccio, Washington University School of Medicine:
Multiple sclerosis
calorie restriction
adipokines

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases