Clinical trial NCT02986893: Pilot Diet Study for Multiple Sclerosis
Official title: Pilot Study of a Dietary Intervention for Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Diet
Clinical Trial
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-65, inclusive
* Female
* Self-reported race of white or black
* Diagnosis of CIS with MRI consistent with MS, RRMS, or PPMS by McDonald 2010 criteria or SPMS by Lublin 2014 definition
* If the subject is receiving treatment with disease-modifying therapy, must be on that therapy for at least 3 months prior to randomization
* Willing and able to be randomized to dietary intervention with commitment to rigorously follow the dietary protocol and complete the necessary assessments over 6 months

Exclusion Criteria:

* MS exacerbation within 60 days of protocol start
* Intravenous corticosteroids within 60 days of protocol start
* Patients with severe medical or psychiatric illness that would interfere with their ability to comply with the protocol, or potentially cause the patient harm as determined by the treating physician
* Active smoking at the time of protocol start
* Taking supplements other than approved doses of vitamin D within 1 month of study start
* Pregnancy or planning pregnancy during the study period, breastfeeding

Primary outcomes:
measure: Food Frequency Questionnaire
timeFrame: at 6 months
measure: Carotenoids level
timeFrame: at 6 months
measure: Pooled fatty acids level
timeFrame: at 6 months
measure: Urinary sodium level
timeFrame: at 6 months
Secondary outcomes:
measure: Change in Blood pressure
timeFrame: Baseline, 3 months, 6 months
measure: Change in body mass index
timeFrame: Baseline, 3 months, 6 months
measure: Change in lipid profile
timeFrame: Baseline, 6 months
measure: Change in fasting glucose level
timeFrame: Baseline, 6 months
measure: Change in hemoglobin a1c level
timeFrame: Baseline, 6 months
measure: Change in Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: Baseline, 3 months, 6 months
measure: Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: Baseline, 3 months, 6 months
measure: Change in the Minimum Assessment of Cognitive Function in MS (MACFIMS)
timeFrame: Baseline, 6 months
measure: Neurological Fatigue Index-MS
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
name: Ilana Katz Sand, MD
role: PRINCIPAL_INVESTIGATOR
References: