Yale MS Center
New Haven, Connecticut, 06519, United States
NCT Number: NCT02282878
The purpose of this work is to investigate the influence of dietary salt intake on immune function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06519, United States
The purpose of this work is to investigate the influence of dietary salt intake on immune function in MS subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake. This is a 5-week pilot study of a dietary intervention of 25 subjects with MS or Clinically Isolated Syndrome (CIS) by 2010 Diagnostic Criteria who will be identified and recruited from the Yale MS Center and/or referred from outside MS centers. 25 age-matched healthy controls will be recruited from friends, family members, spouses and the patient waiting room at the Yale MS Center.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet
Time frame: Change from baseline at 2 weeks
Frequency of Th17 cells will be measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets
Time frame: Change from baseline at 2 weeks
Frequency of regulatory T cells as measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets
Yale University
Other
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