Multiple Sclerosis Clinical Trial
Official title:
A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis
This is a pragmatic, single-blinded randomized trial of improving adherence to dietary interventions in patients with MS who are receiving monthly natalizumab infusions.
MS affects at least 400,000 people in the US alone, and its incidence has increased in the
past 50 years, likely due to changing environmental risk factors. Recent research suggests
that diet may be a critical factor in the development of MS. The "Western diet", high in
sugar, fat, and salt, may influence MS risk and progression by directly affecting the immune
system, altering gut bacteria, and changing metabolism.
Studying patients with MS who are overweight and obese may be relevant as obesity can cause
chronic low-grade inflammation, potentially worsening MS symptoms. Diet modification
represents an interesting potential therapy for MS, particularly calorie restriction and
fasting, which have been associated with reduced markers of inflammation. In addition to
these direct effects, weight optimization may lead to improvements in MS-related symptoms,
like fatigue, and overall quality of life.
This is a single-blinded randomized trial of adherence to a dietary intervention in patients
with MS who are receiving monthly natalizumab infusions. The study will evaluate how use of
technology may help patients with MS adhere to a calorie restricted diet. It will also
evaluate the effect of weight loss on fatigue and quality of life in patients with MS. A
second part of the study will evaluate if shortening the period during the day in which
people consume their typical food amounts leads to improvements in patient-reported outcomes.
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