Pilot Diet Study for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The goal of this project is to establish the feasibility of dietary research in Multiple
      Sclerosis (MS) patients as well as to provide preliminary data to support future clinical
      trials of diet in MS. This project is a pilot randomized trial of a dietary intervention in
      MS patients. The dietary intervention was designed to include dietary components that have
      been suggested to be of benefit in MS through basic science research and observational-type
      studies in MS patients and to exclude those that have been suggested to be detrimental. It is
      therefore rich in foods that are high in polyunsaturated fatty acids (particularly omega-3
      fatty acids), foods that are high in polyphenols and antioxidant vitamins such as berries and
      other fruits and vegetables, as well as whole grains, and excludes meat other than fish as
      well as dairy and refined sugars and limits salt. Subjects are randomly assigned to the
      dietary intervention or to the non-intervention group. The non-intervention group will be
      invited to attend regular meetings with a focus on wellness in MS however will not receive
      specific dietary instructions. At the end of the study those who were not in the dietary
      intervention group will have the opportunity to receive all of the materials used during the
      study should they wish to begin the diet.
    

Detailed description: 
      This is a pilot study of a carefully-designed dietary intervention that aims to help overcome
      obstacles to diet research in MS as well as provide needed preliminary data for future
      clinical trials. It incorporates elements with suggested benefits for MS including foods high
      in polyunsaturated fatty acids, polyphenols, and antioxidants, and excludes those that are
      potentially detrimental such as dairy and saturated fat from meat, refined sugars, and also
      limits salt content.

      The 15 participants randomized to the dietary intervention arm will undergo intensive
      training with a nutritionist and the PI regarding the mechanics of the diet. Menu
      suggestions, recipes, and grocery lists will be provided. This will be followed by regular
      meetings and contact with all study participants by e-mail and phone to maximize dietary
      adherence. The 15 subjects not in the dietary intervention group will have regular meetings
      at the center with a focus on wellness in MS in general. Adherence to the diet will be
      assessed through the use of multiple validated dietary questionnaires as well as through
      biological specimen analysis. Feedback will be requested to provide valuable advice from
      participants that can be applied to future clinical trials. Effects on general health and
      wellness outcomes such as BMI, lipid profile, fasting glucose, hemoglobin a1c, blood
      pressure, as well as effects on fatigue and cognition will be explored. Fecal specimens for
      microbiota analysis and blood samples for immunological profiling will be collected and
      stored for future analysis to help elucidate potential mechanisms for dietary effects.
    

Intervention name(s): Dietary Intervention; Non-dietary Intervention Arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be assigned to follow a specific diet for 6 months. This will involve meetings with the study nutritionist at least monthly as well as regular assessments related to adherence and effects.; Participants will be requested to follow their usual diet and attend monthly meetings at the MS center to discuss various topics with a focus on wellness in MS for 6 months.
Other intervention name(s): Monthly MS Center meeting attendance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Diet; Clinical Trial