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Pilot Diet Study for Multiple Sclerosis

NCT02986893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-10-03

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Dietary Intervention

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.

BEHAVIORAL

Non-dietary Intervention Arm

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.

Sponsors & Collaborators

Principal Investigators

  • Ilana Katz Sand, MD · Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986893 on ClinicalTrials.gov