Multiple Sclerosis Clinical Trial
Official title:
A Pilot Study of Adipokines and Calorie Restriction in Multiple Sclerosis Patients
NCT number | NCT02411838 |
Other study ID # | 201307106 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | June 2017 |
Verified date | May 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University in St Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood biomarkers | Serum levels of: adipokines (leptin, adiponectin and resistin) | After two weeks, 3 and 6 months | |
Primary | Blood biomarkers | Pro-inflammatory cytokines (IL-6, TNFalpha), | After two weeks, 3 and 6 months | |
Primary | Blood biomarker | cortisol | After two weeks, 3 and 6 months | |
Primary | Blood biomarker | T regulatory cell number and in vitro function | After two weeks, 3 and 6 months | |
Secondary | Clinical - Disability on the Expanded Disability Status Scale (EDSS) | 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. | Two weeks, 3 and 6 months | |
Secondary | Clinical-Ambulation, hand and cognitive functions on the Multiple Sclerosis Functional Composite (MSFC) scale | The MSFC is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. (Cutter et al, 1999). | Two weeks, 3 and 6 months | |
Secondary | Clinical - Cognitive functions using the Symbol Digit Modality Test (SDMT). | The SDMT is a simple test to assess cognitive functions over time and assess response to treatment. | Two weeks, 3 and 6 months | |
Secondary | Clinical - Quality of life on the Multiple Sclerosis Quality of Life Inventory (MSQLI). | The MSQLI is a questionnaire to assess quality of life in MS patients. | Two weeks, 3 and 6 months | |
Secondary | Gut microbiome changes ( stool sample ) | A stool sample will be collected to assess the effect of the diet on the gut microbiome. | Two weeks, 3 and 6 months |
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